Remember me
Type 2 diabetes is a chronic condition where the body becomes resistant to the normal effects of insulin and gradually loses the capacity to produce enough insulin in the pancreas []. The onset of type 2 diabetes is associated with both nonmodifiable (eg, genetic) and modifiable (eg, health and behavioral) risk factors []. Worldwide, in 2020, type 2 diabetes was the ninth leading cause of death, affecting 7% of the population, with prevalence rates only expected to increase []. In Australia, type 2 diabetes impacts an estimated 1.2 million people [], with a further 2 million having prediabetes []. It is the fastest-growing chronic condition in Australia [], with health system expenditure estimated at Aus $3.4 billion (US $2.1 billion) per year []. Type 2 diabetes has a significant impact on individuals. Along with the symptoms of the disease itself, many people experience diabetes-related complications (eg, retinopathy, peripheral vascular disease, and ischemic heart disease) and are at increased risk of multimorbidity (eg, cardiometabolic, vascular, and mental health conditions), which collectively impact their quality of life, impair functioning, and increase financial and economic burden []. Type 2 diabetes disproportionately affects disadvantaged groups. For example, people of a low socioeconomic status and with low levels of education [], immigrants, and those from culturally and linguistically diverse backgrounds have increased risk of type 2 diabetes []. Furthermore, the intersection of disadvantage is likely to magnify risk and burden of disease [].
Management of type 2 diabetes is primarily focused on achieving glycemic control through modification of health behaviors (typically physical activity and nutrition) and, where required, medication. Evidence-based management of type 2 diabetes emphasizes person-centered, team-based care with integrated long-term treatment approaches, as well as the involvement of social community support [,]. Self-management, where the person with type 2 diabetes works in partnership with their social supports and health professionals to understand, manage, and optimize their health, is the goal. Management of modifiable risk factors is a core component of self-management, with such strategies focused on building positive health behaviors, including physical activity and nutrition, and optimizing psychological well-being [,]. Multidisciplinary, group-based approaches to lifestyle modification have consistently been shown to positively impact a range of health and well-being outcomes for people living with type 2 diabetes []. To support this in practice, the Australian National Diabetes Strategy (2021-2030) has called for a multisectoral response by government and communities to provide the integrated care required [].
UQ Health Care (a not-for-profit health care wholly owned enterprise of The University of Queensland) has established Logan Healthy Living as a specialist clinic designed to respond to this need []. Purposefully established in South East Queensland in the City of Logan, an area of Queensland with high burden of type 2 diabetes and intersectional disadvantage, Logan Healthy Living was designed with the aim of reducing the burden of disease on individuals, the community, and the health system []. The core service of Logan Healthy Living is a group-based lifestyle management program delivered by an interprofessional allied health team focusing on supporting people living with and at risk of type 2 diabetes in Logan. The program has 3 main foci: physical activity, healthy eating, and well-being []. Logan Healthy Living is a 4-year proof of concept delivered by a Queensland-first alliance among primary health care; tertiary hospital and health services; and government, community, and university sectors.
A key feature of the establishment of Logan Healthy Living was the integration of an outcome-based funding model—a model that prioritizes value-based care and patient-centered outcomes and leverages multisectoral partnerships. Critical to value-based care models is the collection and use of data to continually evaluate the impact of the service on the participants as well as the health system more broadly []. Moreover, leveraging this approach for practice-based evidence generated in “real-world” settings can add to the currently limited evidence on community-based, self-management programs for people living with or at risk of type 2 diabetes []. With dimensions at both the individual level and multiple ecological levels, the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework [,] offers a balanced and pragmatic approach to the evaluation of applied community-delivered programs considering factors such as the characteristics of the participants who take up the program (reach) and participant satisfaction (implementation). The RE-AIM framework has been applied across multiple evaluations, including diabetes health coaching [], diabetes prevention programs [], and telephone-delivered type 2 diabetes support []. To simultaneously support reporting for the outcome-based funding model and evaluate the real-world impact of a routinely delivered community program, a comprehensive continuous evaluation protocol informed by the RE-AIM framework was developed.
ObjectivesThe purpose of this paper is to describe the development of Logan Healthy Living and the protocol for program evaluation of this allied health care service. Specifically, we describe the context and setting of the service, the multisectoral partnership and co-design activities contributing to the service development, governance, and participants and recruitment channels. We then describe the protocol for the evaluation of the service according to the RE-AIM framework.
This protocol was prepared using the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist [].
Context and SettingLogan Healthy Living by UQ Health Care is located in the City of Logan in South East Queensland, Australia. With an estimated population size of 345,098 [], the City of Logan is identified as one of the most culturally and linguistically diverse and socioeconomically disadvantaged areas in Australia. The proportions of the population speaking a language other than English at home; being born overseas; identifying as Aboriginal or Torres Strait Islander, Māori, or Samoan; being unemployed; and having one or more chronic health conditions are above South East Queensland averages []. The region has also experienced rapid population growth and has an aging population []. The City of Logan has a strong focus on community services and fostering connection, with a wide range of no- and low-cost community social programs, including Logan City Council Libraries; arts, culture, and heritage initiatives; sport and recreation facilities (including the Active and Healthy program offering >100 weekly free and low-cost health and well-being activities); and parks and community gardens. Logan also has a diverse range of cultural groups and grassroots networks supporting community connection [].
In Logan, estimates of the prevalence of type 2 diabetes and associated indicators of burden of disease are consistently higher than state-based estimates for Queensland. Almost 20% (18.5%) of people aged ≥75 years living in Logan have type 2 diabetes (12.4% for those aged 55-74 years and 1.7% for those aged 18-54 years) [], with the third highest rate of insulin-treated type 2 diabetes in Australia (an indicator of advanced or nonresponsive progression of the disease) []. Type 2 diabetes accounts for 31% of potentially preventable hospitalizations in Logan, making it the leading cause of potentially preventable hospitalizations []. Those living with type 2 diabetes in the area are also disproportionately likely to die from diabetes-related causes, with the average diabetes-specific mortality rate in Logan being 32% higher than that for Queensland in general [].
Development of Logan Healthy LivingThe concept of a multisectoral, allied health–delivered lifestyle management program for people living with type 2 diabetes in Logan emerged from an existing partnership between UQ Health Care and Metro South Health (the region’s public health care provider) []. In 2014, Metro South Health and UQ Health Care established an innovative, integrated primary-specialist model of care for the medical management of people with complex diabetes, the “Beacon” model []. The Beacon model saw complex diabetes management provided within a community practice by a multidisciplinary team consisting of an endocrinologist from Logan Hospital, 2 to 3 general practitioners (GPs) with a special interest in diabetes from UQ Health Care, and a diabetes nurse educator from the Metro South Health community team who provided 1:1 consultation (at times before the GP with a special interest in diabetes to assist in triage). The aim of the Beacon model was to build capacity in primary care for managing complex diabetes through advanced management plans and subsequently diverting people with type 2 diabetes from tertiary care. While the Beacon model demonstrated favorable outcomes in changes in hemoglobin A1c (HbA1c) concentration and the percentage of patients meeting combined clinical targets of HbA1c concentration, blood pressure, and low-density lipoprotein cholesterol [], key stakeholders acknowledged that the Beacon model alone was not sufficient to address the rising community need. Moreover, it lacked a health behavior change program focused on self-management—a critical component for the management of type 2 diabetes [].
To address these needs, in approximately 2019, what would eventually be known as “Logan Healthy Living” was envisioned, expanding on the existing partnership between Metro South Health and UQ Health Care and integrating learnings from the Beacon model and UQ Health Care’s experience in delivering interprofessional, allied health services at other sites. The first phase of service development was establishing an alliance of partners underpinned by a commitment to prevent chronic disease and keep people well and out of hospital in Logan. UQ Health Care and Metro South Health led the establishment of the alliance, which in turn also included the Brisbane South Primary Health Network, The University of Queensland, and Griffith University. By early 2020, the alliance had established a proof-of-concept model for a comprehensive lifestyle management program delivered by an interprofessional team of allied health professionals and infused with a student allied health workforce.
Concurrently, in 2019, the Queensland Government established the state’s first prevention agency, Health and Wellbeing Queensland []. The concept of Logan Healthy Living, a service delivering comprehensive lifestyle management programs to support behavior change and self-management, was put to the board of Health and Wellbeing Queensland by UQ Health Care and Metro South Health on behalf of the alliance. The proposal was strongly aligned with the vision and strategic plan of the newly formed Health and Wellbeing Queensland, which included developing and trialing new models of care for the prevention and management of chronic disease. Here, the intention was to reduce pressure on the tertiary health care system, address health inequities, and build multisectoral partnerships that drive system-level change for improved health and well-being outcomes. In 2021, Health and Wellbeing Queensland joined the alliance, with UQ Health Care and Health and Wellbeing Queensland entering into a 4-year agreement (2021-2024) to support the delivery of a tailored lifestyle management program. UQ Health Care secured additional revenue agreements and financial contributors to deliver on the commitment to reduce financial barriers for participants. The UQ Health Care and Health and Wellbeing Queensland service-level agreement outlined a comprehensive suite of deliverables and biannual key performance indicators. These key performance indicators were designed to evaluate the program according to the RE-AIM indicators across the 3 priorities identified previously (reduce the burden of disease on individuals, the community, and the health system). Examples of the agreed upon key performance indicators are summarized in .
Table 1. Examples of key performance indicators for Logan Healthy Living.Evaluation domainKey performance indicatorReachParticipant’s type 2 diabetes status (at risk, newly diagnosed, complex, or chronic)The development and design of the service was community led and iteratively co-designed with key stakeholders, including consumers. Activities included participant journey mapping to inform program and resource development, consultation with student placement providers, and learning needs assessments for local GPs. A key event for consumer and stakeholder engagement was a half-day “design-jam” led by UQ Ventures and held on campus at Griffith University in Meadowbrook, where approximately 60 end users, delivery providers, academics, clinicians, community leaders, and representatives of other key stakeholders (eg, Metro South Health, Brisbane South Primary Health Network, and the Aboriginal and Torres Strait Islander Community Health Service) came together to progress their combined vision and implementation plan for the service. Subsequent planning days have also been hosted, which have similarly included Logan Healthy Living staff, key stakeholders, and consumers.
Simultaneously, the plan for routine collection of reporting and evaluation data was co-designed by key stakeholders, including researchers from The University of Queensland; the Logan Healthy Living Clinical and Operations Manager, administration team, and clinicians; and relevant content experts. Key to successfully collecting the range and breadth of data required was the intent to embed data collection into routine service delivery. Led by a researcher employed by the Health and Wellbeing Centre for Research Innovation (a research center jointly funded by The University of Queensland and Health and Wellbeing Queensland; SG), along with a senior academic experienced in evaluation (GH) and a data analyst (EW), a pragmatic data collection and consent process was co-designed and embedded into daily operations. Data are collected through both practice management software (Gensolve) and clinical trial software (REDCap [Research Electronic Data Capture]; Vanderbilt University) and facilitated day to day by the Logan Healthy Living clinical team, with technical and content support on an as-needed basis from The University of Queensland. Implementation of the data collection process was supported by on-site training sessions and a comprehensive manual developed by the data analyst. The Clinic and Operations Managers have been essential in establishing and building a culture for collaboration and prioritization of data collection.
FacilitiesLogan Healthy Living went live for operations in July 2021. The service initially operated from Griffith University Logan Healthcare Centre, where it was intentionally colocated with the Beacon Clinic and Metro South Health Chronic Disease Diabetes Service (which included diabetes educators, nurse practitioners, and a podiatry service). In February 2023, Logan Healthy Living moved into its permanent, purpose-built location in a dedicated health and medical clinic, Meadowbrook Medical Centre, colocated with the UQ Health Care Meadowbrook GP clinic and the Logan Hospital endocrinology outpatient services (Logan Endocrine and Diabetes Service). The Meadowbrook Medical Centre is centrally located in the City of Logan and positioned within the community’s transport and retail hub, Logan Hospital, and the Logan Healthy Kids Club and Good Start programs operated by Children’s Health Queensland. The site is also set to become part of a larger health precinct, with a planned staged expansion of Logan Hospital and an additional 2 private hospitals.
Logan Healthy Living occupies 400 m2 at Meadowbrook Medical Centre and includes a gym floor, 5 curtained consultation spaces, 2 individual consultation rooms, 2 large private rooms (used for staff or student rooms or for group education sessions), and an integrated open space dedicated to delivering group education. The open gym includes a range of exercise equipment, including cardiovascular training equipment (treadmill and stationary bicycle), parallel bars, steps and stairs, and resistance and balance training equipment. UQ Health Care invested in state-of-the-art resistance training machines by HUR Australia [] that use air resistance and SmartTouch software for automatically programming and tracking load and equipment position (eg, seat heights), with participants tapping on and off the equipment with a personalized radio-frequency identification wristband. HUR Australia equipment was selected to reduce the barriers and improve safety with resistance training for older adults and new exercisers; the HUR Australia equipment is fully automated and applies smooth and consistent resistance across the range of motion.
The clinic is staffed by a range of allied health professionals, including physiotherapy, exercise physiology, dietetics, diabetes education, and health psychology professionals. With its student-infused model, the service also provides clinical education and placements for students from Griffith University and The University of Queensland. These include clinical placements for physiotherapy, exercise physiology, dietetics, and psychology students (ranging from 4 to 20 weeks in length) and project placements in a wide range of health disciplines such as nutrition and dietetics, pharmacy, social work, and health service management. Students from a range of disciplines work together to provide an interprofessional model of care. Beyond providing health care services, Logan Healthy Living is also further embedding itself into the community by contributing to the development and career selection of a locally based workforce, with the aim to promote workforce sustainability in the region. Examples of these activities include facility tours with question-and-answer sessions and opportunities for work experience with the Logan Healthy Living team for local high school students with interest in health careers.
GovernanceLogan Healthy Living is governed by a multisectoral steering committee that is cochaired by UQ Health Care and Health and Wellbeing Queensland. Beyond UQ Health Care and Health and Wellbeing Queensland, the steering committee includes representatives from The University of Queensland, Griffith University, Metro South Health, Logan Hospital, Brisbane South Primary Health Network, and Logan Healthy Living participants. Members of the steering committee are responsible for providing program leadership and direction (eg, understand strategic implications and outcomes and accept responsibility for program strategy and overall benefit realization) and governance (eg, risk identification and mitigation, stakeholder management, and monitoring of progress) and maximizing program benefits (eg, monitor program outputs and monitor implementation and evaluation). Additional stakeholders are also consulted by the steering committee, such as broader consumer groups, the Aboriginal and Torres Strait Islander Community Health Service, Children’s Health Queensland, and Diabetes Australia.
Logan Healthy Living is connected to the broader community governance of the Logan region through the Meadowbrook Partnership Group. Established in 2018, the group comprises representatives from key organizations who are positioned to influence integration and impact in Logan. Membership includes Brisbane South Primary Health Network; Logan City Council; Metro South Health; Economic Development Queensland; Loganlea State High School; The University of Queensland; Griffith University; and the Department of State Development, Infrastructure, Local Government, and Planning. Collectively, the membership represents state, federal, primary care, education, and local government stakeholders. All members have strong community relationships and understanding of local issues. Logan Healthy Living (clinical and operations manager) and UQ Health Care (chief executive officer) are members of the Meadowbrook Partnership Group. shows the network of key stakeholders involved in the development and delivery of Logan Healthy Living.
Figure 1. Logan Healthy Living key stakeholder network. Program Cost, Participants, Referral Pathways, and Intake ProcessLogan Healthy Living delivers services at no cost to participants. Where possible, reimbursement for the lifestyle management program is sought through Medicare, Australia’s universal health insurance scheme that provides free or subsidized health care (Medicare Benefits Schedule) and selected medication (Pharmaceutical Benefits Scheme, including diabetes medications) for Australian and New Zealand citizens, permanent residents, and some temporary residents. Specifically, Logan Healthy Living seeks reimbursement through the Medicare Benefits Schedule (group allied health service for type 2 diabetes), which funds 1 intake assessment (Aus $74.80 [US $46.99]) and 8 group sessions (Aus $18.65 [US $11.72] per session per person) per calendar year []. To claim Medicare benefits, the group sessions must include between 2 and 12 people; last at least 60 minutes; and be delivered by a credentialed diabetes educator, accredited exercise physiologists, or accredited practicing dietitian []. While the lifestyle management program is the primary service, participants are also able to access 1:1 consultations with health professionals on an as-needed basis.
To be eligible for the Logan Healthy Living lifestyle management program, participants must have a diagnosis of type 2 diabetes and be aged ≥16 years. While the program is intended for people living in the Logan region, no one is excluded from the service based on their geographical address. Participants may be excluded if it is identified by the clinical team that a group program may not be a feasible method of service delivery (ie, a participant requiring 1:1 education support). At Logan Healthy Living, services are currently delivered in English, and there is no access to free interpreter services (eg, through state or national government programs). However, clinical services have been delivered to participants who do not speak English when supported by a carer or support person.
Participants are primarily referred to the program by GPs using a referral form for group allied health services under Medicare for patients with type 2 diabetes. Participants are also able to self-refer through an expression of interest form on the service’s website. Word of mouth and marketing activities support self-referrals, such as the service’s website and newsletter, referrals from specialists (eg, the Logan Endocrine and Diabetes Service), and local advertising (eg, booths at local shopping centers, open days, and notice boards). Self-referrals may also be driven more broadly through the activities and promotion of the service by members of the alliance (eg, Metro South Health, Health and Wellbeing Queensland, Brisbane South Primary Health Network, UQ Health Care, Griffith University, and The University of Queensland). Where participants self-refer and do not have a GP referral, they are encouraged to obtain one so that the service can be reimbursed through Medicare; however, in cases in which there are barriers, this does not preclude admission into the lifestyle management program. For example, participants may experience financial barriers to primary care. While visits to GPs are subsidized by Medicare in Australia for some people, visits often attract a gap payment; services that provide no-gap primary care (bulk bill only) are limited; and some participants may not be eligible to enroll in Medicare and, therefore, ineligible for subsidized consultations. Participants can re-enroll in the program once per calendar year.
Upon presenting to Logan Healthy Living, participants are booked for an intake assessment, which is arranged over 2 appointments (appointments 1.1 and 1.2). The first appointment (1.1) is focused on medical history screening (using referral information where possible) and physical assessments. If it is identified at this first appointment that more information is required to safely prescribe exercise, the team may place the participant’s referral on hold until medical authorization to exercise is provided by the referring GP or (if self-referred) the participant’s usual GP. The second appointment (1.2) is focused on identifying barriers to participation in the lifestyle management program, goal setting, and an introduction to the exercise program. In between the 2 appointments, participants complete web-based, self-report surveys and are invited to indicate whether they agree or disagree to providing written informed consent for their data to be included in a research data registry (further details on ethics are described in the evaluation protocol in the Ethical Considerations section). Screening for completion of surveys and consent forms is conducted by the reception team, with face-to-face support for completion provided by the clinicians at the second appointment if required. After completion of the intake assessment, participants are allocated to the next available group according to their support needs and whether they are most suited for a “recently” diagnosed or “chronic” group allocation based on time since diagnosis.
Logan Healthy Living Lifestyle Management ProgramOverviewThe lifestyle management program is the primary service delivered by Logan Healthy Living. The program was developed and is delivered in line with the American Diabetes Association Standards of Care in Diabetes [], which outline recommendations for a range of factors related to the management of people with type 2 diabetes. In particular, the Logan Healthy Living lifestyle management program follows the key recommendations for diabetes self-management education and support, medical nutrition therapy, routine physical activity, health behavior counseling, and psychosocial care. The program incorporates a range of behavior change strategies (as described in the Behavior Change Technique Taxonomy by Michie et al []), including goals and planning (eg, goal setting and action planning), feedback and monitoring (eg, biofeedback), social support (eg, unspecified, emotional, and practical), shaping knowledge (eg, instruction on how to perform the behavior), comparison of behavior (eg, demonstration of the behavior), repetition and substitution (eg, graded tasks), comparison and outcomes (eg, credible source), identity (eg, framing and reframing), and self-belief (eg, verbal persuasion about capability) [].
Program StructureThe lifestyle management program is delivered face-to-face in groups over 8 weeks using an interprofessional model of care. Each week includes one 2-hour session that comprises a 60-minute education workshop and a 60-minute supervised exercise (“movement”) session. Each group has a maximum of 10 participants and is assigned an education workshop and an exercise lead (either health psychologist and exercise physiologist or diabetes educator and physiotherapist, respectively) who supports and provides services to the group throughout the 8 weeks. “Recharge” sessions are offered at 1, 3, 6, 9, and 12 months following completion of the 8-week program to provide an opportunity for participants to reconnect with their health care team, review their goals, and participate in a follow-up assessment before being discharged at 12 months. The 1-month recharge is conducted face-to-face, with the remaining sessions conducted via telephone. The education workshops and supervised movement sessions are conducted on-site at Logan Healthy Living, with movement sessions conducted in the fully equipped, on-site gym.
Program ContentA week-by-week overview of the topics, key concepts, and resources provided in the education workshops is detailed in . The education workshops were designed to be patient centered and focus on diabetes self-management education with the clinical support needed to facilitate the knowledge, decision-making, and skill mastery necessary for diabetes self-care. Education workshop topics are integrated with social prescribing, where opportunities for community engagement related to that week’s content are signposted to support longer-term behavior change and address the broader social determinants of health. In addition to being signposted to local programs, participants are signposted to Health and Wellbeing Queensland’s suite of prevention programs, including 10,000 Steps and Deadly Choices []. The supervised movement session comprises an individually prescribed exercise program targeting combinations of cardiovascular fitness, strength, or flexibility depending on participant presentations. All participants are provided with the opportunity to have an individually prescribed home exercise program or access to Physitrack [], an app that supports home exercise prescription and monitoring.
Table 2. Overview of the education workshop topics for the Logan Healthy Living lifestyle management program.WeekDescriptionKey conceptsHandouts1Welcome and orientationAcknowledgment of CountryaaAn Acknowledgment of Country is delivered at the beginning of each week.
bHbA1c: hemoglobin A1c.
cDESMOND: Diabetes Education and Self-Management for Ongoing and Newly Diagnosed.
Evaluation Protocol for the Logan Healthy Living Lifestyle Management ProgramGuided by the RE-AIM framework, the evaluation protocol was developed in partnership with the Health and Wellbeing Centre for Research Innovation at The University of Queensland and the other members of the steering committee and was designed to inform the service-level agreement and key questions regarding the uptake, effectiveness, costs, and sustainability of the program.
Study DesignThe evaluation is a single-arm intervention design where participants are evaluated at intake to the service (before the program); at the end of the supervised program (8 weeks); and at approximately 1, 3, 6, 9, and 12 months after the end of the supervised program. For participants who do not re-enroll in the program, annual follow-ups are conducted at 2, 3, and 4 years.
MeasuresOverviewA summary of measures that are being collected from participants to describe contextual information, program effectiveness, and acceptability is provided in , with further details and outcomes from other data sources described in the following sections. All self-report surveys are administered using REDCap, service-level data are extracted from practice management software, and physical measures are administered by clinicians on-site.
Table 3. Outline of participant self-report measures and timing of assessmentsa.MeasuresStructured programExtended follow-upsaAll self-reported 12-month assessments (except smoking) are repeated annually at the 2-, 3-, and 4-year follow-ups.
bSmoking status is assessed at intake, and change in smoking status is assessed at 8 weeks and 12 months.
cHbA1c: hemoglobin A1c.
Reach OutcomesProgram UptakeProgram uptake will be described by reporting the number of participants who enroll in and commence the lifestyle management program compared to those considered ineligible. These outcomes will be tracked using appointment data from the practice management software, Gensolve. Withdrawals from the program and reasons for withdrawal will be tracked by clinicians using REDCap.
Sociodemographic and Other Contextual CharacteristicsDemographic data are collected at intake on time since diagnosis of type 2 diabetes, age, sex assigned at birth, gender, postcode, First Nations status, country of birth, language spoken at home, highest level of education, occupation, and employment status. Other contextual information is collected at intake and tracked throughout the program. Smoking status is assessed at intake, and smoking changes are collected at the 8-week and 12-month follow-ups. Use of digital health technologies (eg, apps, wearables, and telehealth) is collected at intake, 8 weeks, 12 months, and then annually. Community involvement is collected at each of the assessments except for the 1-month follow-up by asking participants to report whether they take part in the following activities outside the home: social-based groups, exercise-based groups, combined social and exercise groups, and art and craft–based activities.
Effectiveness OutcomesDiabetes-Related DistressThe primary effectiveness outcome for the evaluation is diabetes-related distress. Diabetes-related distress will be assessed using the Problem Areas in Diabetes scale []. The Problem Areas in Diabetes scale is a self-report, validated questionnaire that comprises 20 items assessing diabetes-related problems, with participants asked to indicate whether each item is “not a problem,” “a small problem,” “a moderate problem,” or “a somewhat serious problem.” Scores of ≥40 to 40 are considered “severe distress”; distress on specific items is considered when the total is not ≥40 but the score on one or more items is ≥3. Participants have “no evidence of distress” when both previous definitions are not met.
Health BehaviorsPhysical activity will be assessed using the Active Australia Survey, a validated self-report measure []. The Active Australia Survey is designed to measure participation in leisure-time physical activity. It offers a short and reliable set of questions that can be easily administered via self-report or interview. Sitting time will be measured using an adapted version of the AusDiab multicontext sitting questionnaire, which asks participants to recall weekday and weekend day sitting time over the previous 7 days [].
Nutrition-related behaviors will be assessed using 14 self-report items sourced from the 13-item Diet Quality Tool by O’Reilly and McCann [] and 4 items from the evaluation of the Get Healthy Service [], with redundant items removed. The Diet Quality Tool [] has been validated in an Australian clinical population and reflects overall dietary quality relative to national recommendations. The New South Wales Get Healthy Service items, derived from population surveys—daily servings of fruit and vegetables as per the National Nutrition Survey [], as well as daily servings of sweetened drinks per day and takeaway meals per week from the New South Wales Population Health Survey []—are useful stand-alone items for comparing results to those of other interventions such as the Get Healthy Service.
Alcohol consumption will be assessed using the brief 3-item version of the Alcohol Use Disorders Identification Test. The Alcohol Use Disorders Identification Test provides both a continuous score that correlates with alcohol consumption and adverse drinking consequences and a valid screening tool for detecting alcohol use disorders and risky drinking with validity in numerous populations, including primary care samples [].
Quality of LifeQuality of life will be assessed via self-report using the EQ-5D-5L. The EQ-5D-5L is a widely used and validated tool to measure health-related quality of life []. The questionnaire comprises 5 dimensions—mobility, self-care, usual activities, pain or discomfort, and anxiety or depression—and participants are asked to report their level of difficulty with each dimension: no problems, slight problems, moderate problems, severe problems, and extreme problems. It also asks participants to self-rate their health on a numerical scale from 0 to 100.
Self-Management Self-EfficacySelf-management self-efficacy will be measured via self-report using the Patient Motivation Questionnaire []. The Patient Motivation Questionnaire comprises 10 statements related to patients’ understanding and confidence in the self-management of their condition. The score is calculated as a total out of 10, with 8 items required to be completed.
LonelinessLoneliness will be assessed via self-report using a valid and reliable scale that asks 4 questions to capture different aspects of loneliness []. The first 3 questions are from the University of California, Los Angeles, 3-item loneliness scale. Scores from the 3 items are used to determine whether the participants are lonely (scores of 6-9) or not lonely (scores of 3-5). The final question is a direct question on how often the respondent feels lonely.
Anthropometric MeasuresA combination of directly measured and self-report methods will be used to assess weight (kg) and waist circumference (cm). Directly measured weight will be assessed during the 1.1 intake appointment, the 8-week group appointment, and any subsequent face-to-face recharge appointments (not including the 1-month follow-up). Where participants do not attend face-to-face follow-up appointments for direct measures, they will be asked to self-report their weight and waist circumference. Instructional videos will be provided on how participants can best self-administer these measures. The combination of self-report and direct measures is standard practice at the clinic to allow for flexibility in collecting the data in a timely way with respect to the measurement time points while also allowing participants to have measures directly taken if they are at the clinic at the time of their follow-up.
HbA1c MeasuresHbA1c level will be collected using a combination of approaches. For all participants, data will be collected by state pathology laboratories, with the tests conducted closest to intake and the 1-month follow-up after the supervised program (ie, approximately 3 months after baseline) being requested from relevant data custodians. A subsample of participants will have their HbA1c levels collected via finger prick at intake and at the 1-month follow-up, with the point-of-care protocol introduced in January 2024 due to availability of resources.
Physical Function MeasuresThe 2-minute step test [], time to complete 5 sit-to-stand exercises [], and grip strength [] will be assessed at intake and at 8 weeks to evaluate physical function.
Health Care UseHealth care use will be assessed using a self-report measure of use of GP, hospital, and emergency services at baseline and the 12-month follow-up based on questions adapted from those used in the Household, Income, and Labour Dynamics in Australia Survey [,]. In addition, Queensland Health records will be used to quantify emergency department presentations, hospital admissions, bed days, and potentially preventable hospital admissions related to type 2 diabetes (according to the Queensland Health key performance indicator attribute sheets for diabetes-related potentially preventable hospital admissions).
Adoption OutcomesAdoption will be described by estimating the number of referrals and their referral sources.
Implementation OutcomesFidelityFidelity will be assessed using adherence to the program, where adherence is the number of sessions attended. These data will be drawn from the practice management software.
AppropriatenessAppropriateness of the program will be assessed by continuing to monitor program adaptations. These will be tracked using a log similar to that in .
AcceptabilityAcceptability will be determined by assessing participant satisfaction. Participant satisfaction will be assessed using a 4-point Likert scale at the end of the supervised group component of the program (8 weeks), where 1=not at all satisfied, 2=somewhat satisfied, 3=satisfied, and 4=highly satisfied. Participants will be asked to rate their overall service satisfaction, satisfaction with the quality of the services, satisfaction with the first appointment being scheduled within a reasonable period, satisfaction with the staff providing the service, and satisfaction with the written information.
CostsCost of delivery will be assessed using appointment data collected using the practice management software and overall operating costs.
Maintenance OutcomesPrimarily, participant maintenance will be considered using their longer-term outcomes collected at approximately 12 months after the 8-week structured program. Additional perspective will be provided by the extent of re-enrollment after 12 months (or as early as 9 months if clinically indicated), as well as the long-term outcomes at the 2-, 3-, and 4-year follow-ups among those who do not re-enroll in the program.
Sample SizeThe number of participants receiving treatment is not connected to an a priori sample size requirement as it would be in a traditional intervention study. Nonetheless, it is useful to consider how much evaluation data provide an adequate degree of power to detect changes in outcomes. These approximate requirements, based on simple bivariate tests and presented in , show that even a brief evaluation with few participants should be adequate for some outcomes (such as physical activity), whereas a long-running evaluation with many participants might be required to detect the expected changes in sitting time or potentially clinically meaningful changes in quality of life based on the EQ-5D-5L visual analog scale.
Table 4. Approximate number of evaluated participants required to detect 0- to 8-week changes in effectiveness outcomes with 80% to 90% power and 5% 2-tailed significance.MeasureEffect sizeAssumed values, r (SD)Required number of participantsa
Comments (0)