The effectiveness and health-economic evaluation of "Partner in Balance," a blended self-management program for early-stage dementia caregivers: study protocol for a cluster-randomized controlled trial

• Published in: Trials 2023, Vol.24 (1)
• Main Authors: Osstyn, Sander L, Handels, Ron, Boots, Lizzy M. M, Balvert, Sanne C. E, Evers, Silvia M. A. A, de Vugt, Marjolein E
• Format: Report
• Language: English
• Subjects: Care and treatment; Caregivers; Dementia; Economic aspects; Education; Self-care, Health; Social aspects; Study and teaching
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-023-07423-9

Background Informal caregivers of people with dementia are crucial in dementia care. However, they are insufficiently supported and report caregiver burdens, which urges the need for cost-effective interventions aimed at supporting caregivers. This paper presents the design of a study evaluating the effectiveness, cost-effectiveness, and cost-utility of a blended self-management program for early-stage dementia caregivers. Methods/design A pragmatic, cluster randomized controlled trial with a shared control group will be conducted. Participants will be informal caregivers of people with early-stage dementia and will be recruited by local care professionals. Randomization will be carried out at the level of the care professional level in a ratio of 35% to 65% (control arm vs. intervention arm). Participants in the control arm will receive care as usual and the intervention arm will receive the blended care self-management program "Partner in Balance" within a usual care setting in the Netherlands. Data will be collected at baseline and at 3-, 6-, 12-, and 24-month follow-ups. The primary outcome for effectiveness (part 1) is care management self-efficacy. For the health-economic evaluation (part 2) total care costs and the quality of life for individuals with dementia (cost-effectiveness) and quality-adjusted life years (cost-utility) will be the base case analysis. Secondary outcomes (parts 1 and 2) will include depression, anxiety, perceived informal caregiving stress, service-use self-efficacy, quality of life, caregivers' gain, and perseverance time. A process evaluation (part 3) will investigate the internal and external validity of the intervention. Discussion In this trial, we plan to evaluate the effectiveness, cost-effectiveness, and cost-utility of "Partner in Balance" among informal caregivers of people with dementia. We expect to find a significant increase in care management self-efficacy, and the program to be cost-effective, and provide valuable insights to stakeholders of "Partner in Balance." Trial registration ClinicalTrials.gov, NCT05450146. Registered on 4 November 2022. Keywords: Dementia, Economic evaluation, Cost-effectiveness, Cost-utility, Online intervention, Cluster RCT, Blended care, Informal care, Self-efficacy