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: Current controlled trials in cardiovascular medicine Vol. 24; no. 1; p. 427
• 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: Journal Article
• Language: English
• Published: England BioMed Central Ltd 22.06.2023; BioMed Central; BMC
• Subjects: Activities of daily living; Care and treatment; Caregivers; Clinical trials; Cluster RCT; Consent; Cost analysis; Cost-Benefit Analysis; Cost-effectiveness; Cost-utility; Dementia; Dementia - diagnosis; Dementia - therapy; Economic aspects; Economic evaluation; Economic impact; Education; Humans; Institutionalization; Internet access; Intervention; Mental depression; Mental health; Online intervention; Performance evaluation; Professionals; Quality of Life; Randomized Controlled Trials as Topic; Self-care, Health; Self-Management - methods; Social aspects; Study and teaching; Study Protocol; Netherlands; Online intervention; Informal care; Economic evaluation; Self-efficacy; Blended care; Cluster RCT; Cost-effectiveness; Cost-utility; Dementia
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-023-07423-9

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. 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. 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." ClinicalTrials.gov, NCT05450146. Registered on 4 November 2022.