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

Trials

Study Protocol

Sanne C. E. Balvert¹  Silvia M. A. A. Evers²  Marjolein E. de Vugt³  Sander L. Osstyn³  Ron Handels³  Lizzy M. M. Boots³ 

[1] Department of Clinical Neuropsychology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands;Department of Health Services Research and Care and Public Health Research Institute (CAPHRI), Maastricht University, PO Box 6166200 MD, Maastricht, The Netherlands;Centre of Economic Evaluations & Machine Learning, Trimbos Institute, Utrecht, The Netherlands Institute of Mental Health and Addiction, Utrecht, The Netherlands;Department of Psychiatry and Neuropsychology and Alzheimer Center Limburg, School for Mental Health and Neuroscience (MHeNS), Maastricht University, PO Box 6166200 MD, Maastricht, The Netherlands;

关键词: Dementia;    Economic evaluation;    Cost-effectiveness;    Cost-utility;    Online intervention;    Cluster RCT;    Blended care;    Informal care;    Self-efficacy;   

DOI  :  10.1186/s13063-023-07423-9

 received in 2023-03-28, accepted in 2023-05-29,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundInformal 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/designA 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.DiscussionIn 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 registrationClinicalTrials.gov, NCT05450146. Registered on 4 November 2022.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 3

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