Effectiveness of a digitally supported care management programme to reduce unmet needs of family caregivers of people with dementia: study protocol for a cluster randomised controlled trial (GAIN)

Trials

Ina Zwingmann¹  Armin Keller²  Christina Dornquast³  Bernhard Michalowsky³  Melanie Boekholt³  Dilshad Afrin³  Wolfgang Hoffmann⁴  Jochen René Thyrian⁴  Olga A. Klein⁵  Stefan Teipel⁶  Ingo Kilimann⁶  Adina Dreier-Wolfgramm⁷ 

[1] Department for Psychosomatic and Psychotherapeutical Medicine, University Hospital Rostock, Rostock, Germany;Department of Nursing and Management, Faculty of Business and Social Sciences, Hamburg University of Applied Sciences (HAW), Hamburg, Germany;Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE), site Rostock/Greifswald, Greifswald, Germany;Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE), site Rostock/Greifswald, Greifswald, Germany;Institute for Community Medicine, Section Epidemiology and Community Health, University Medicine Greifswald, Greifswald, Germany;Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE), site Rostock/Greifswald, Rostock, Germany;Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE), site Rostock/Greifswald, Rostock, Germany;European University of Applied Sciences (EU FH), Rostock, Germany;Institute of Medical Psychology and Medical Sociology, Medical Faculty, University of Rostock, Rostock, Germany;

关键词: Caregiver of people with dementia;    Caregiver health;    Unmet needs;    Care management system;    Cluster randomised controlled trial;   

DOI  :  10.1186/s13063-021-05290-w

来源: Springer

【 摘 要 】

BackgroundUp to two-thirds of dementia care is provided by family caregivers who often experience high burden, little support and adverse health outcomes. Enabling and supporting family caregivers to provide care at home prevents early institutionalisation of the person with dementia and alleviates the economic burden of dementia in the long term. General practitioners (GPs), as the first point of contact, have a key role in identifying and managing burden and care needs of family caregivers. However, in routine care, this opportunity is often limited by time constraints and even if caregiver needs are recognised, detailed information about regionally available support and advice on healthcare services is often lacking.MethodsThis is a cluster randomised, controlled trial investigating the clinical use and cost-effectiveness of a digitally supported care management programme for caregivers of people with dementia (PwD). Five hundred family caregivers will be randomised at GP offices, specialist practices and memory clinics, with about n=250 participants per arm. Participants are eligible if they are the primary family caregiver of a PwD, are at least 18 years of age and provide informed consent. Participants in the intervention group will receive an individualised care management plan, which will be carried out by qualified study nurses in collaboration with the treating GP. All participants will receive a baseline assessment and a 6-months follow-up assessment. Participants in the wait-list control group will receive usual care. Starting at the 6 months’ follow-up, the former controls will also receive an individualised management plan. Primary outcomes are the number of unmet needs (incl. the Camberwell Assessment of Need for the Elderly, CANE) and health-related quality of life (EQ-5D-5L) at 6 months. Secondary outcomes include caregiver burden (Zarit Burden Interview, ZBI), social support (Lubben Social Network Scale, LSNS), the use of medical and non-medical services (Questionnaire for the Use of Medical and Non-Medical Services, FIMA) and resource utilisation (Resource Utilisation in Dementia, RUD). The primary analysis will be based on intention-to-treat. Between- and within-group analyses and a cost-effectiveness analysis will be conducted to estimate the effect of the tablet PC-based care management programme. This trial is funded by the German Federal Joint Committee (G-BA) Innovation Fund.DiscussionThe findings of this trial will be useful in informing and improving current healthcare system structures and processes to support family dementia caregivers within routine care practices.Trial registrationClinicalTrials.gov NCT04037501. Registered on 30 July 2019.

【 授权许可】

CC BY