Abstract

Background The effectiveness of exercise interventions to improve activities of daily living function in people with dementia is inconclusive. This study aimed to assess the long-term cost-effectiveness of the PrAISED intervention from a National Health Service (NHS) perspective.

Method This novel robust economic analysis used a Markov model to evaluate the incremental cost-effectiveness ratio (ICER) over a lifetime horizon of 15 years for a cohort of patients. Sensitivity analyses were conducted to investigate the uncertainty and robustness of high-impacting parameters and results.

Results This study included 365 adults, aged 65 years and above with 183 and 182 randomised to the PrAISED and standard care groups respectively. The PrAISED intervention had mean per-patient cost of £60,465 for the PrAISED arm and £54,604 for standard care. The Praised intervention gained an incremental QALYs of 0.05 resulting in an ICER of £129,614 per QALY. The sensitivity analysis of the intervention cost varied the ICER value between £68,173 and £191,054/QALY. To achieve the recommended NICE willingness to pay threshold value of less than £30,000/QALYs would require the intervention cost to be reduced from £1,236 (current cost) to £263 to break even and be cost-effective. The sensitivity analyses revealed that there was a 40% probability of standard care dominating the PrAISED treatment.

Conclusions Although the PrAISED intervention was a low-cost intervention, it did not produce a cost-effective intervention in this analysis. The flexibility of the PrAISED program to adapt to government policy during the COVID-19 pandemic was positive.

Trial registration ISRCTN15320670

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

ISRCTN15320670

Funding Statement

This work was funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Reference Number RP-PG-0614-20007). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval was provided by the Yorkshire and The Humber – Bradford Leeds National Research Ethics Service (NRES) Committee Reference 18/YH/0059, with IRAS project identification 236099 and research governance departments in each organisation. All participants gave written informed consent to take part in the research.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

The datasets used and/or analysed during the current study are available from the corresponding author on request or please contact the Principal Investigator Rowan H Harwood for datasets used in the PrAISED study.

ABBREVIATIONADLActivities of Daily LivingCEACCost-Effectiveness Analysis CurveCSICarer Strain IndexDADDisability Assessment for DementiaDEMQoLDementia Quality of LifeEQ-5DEuroqol-five DimensionICERIncremental Cost-Effectiveness RatioHEAPHealth Economics Analysis PlanNHSNational Health ServiceNICENational Institute for Care and ExcellencePSAProbabilistic Sensitivity AnalysisQALYQuality Adjusted Life YearSDStandard DeviationWTPWillingness-To-Pay