Olga A Klein1, Melanie Boekholt2, Dilshad Afrin2, Christina Dornquast2, Adina Dreier-Wolfgramm3, Armin Keller4, Bernhard Michalowsky2, Ina Zwingmann5, Stefan Teipel6,7, Jochen René Thyrian2,8, Ingo Kilimann6,7, Wolfgang Hoffmann2,8. 1. Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE), site Rostock/Greifswald, Rostock, Germany. olga.klein@dzne.de. 2. Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE), site Rostock/Greifswald, Greifswald, Germany. 3. Institute of Medical Psychology and Medical Sociology, Medical Faculty, University of Rostock, Rostock, Germany. 4. Department of Nursing and Management, Faculty of Business and Social Sciences, Hamburg University of Applied Sciences (HAW), Hamburg, Germany. 5. Department for Psychosomatic and Psychotherapeutical Medicine, University Hospital Rostock, Rostock, Germany. 6. Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE), site Rostock/Greifswald, Rostock, Germany. 7. European University of Applied Sciences (EU FH), Rostock, Germany. 8. Institute for Community Medicine, Section Epidemiology and Community Health, University Medicine Greifswald, Greifswald, Germany.
Abstract
BACKGROUND: Up 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. METHODS: This 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. DISCUSSION: The 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 REGISTRATION: ClinicalTrials.gov NCT04037501 . Registered on 30 July 2019.
RCT Entities:
BACKGROUND: Up 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. METHODS: This 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. DISCUSSION: The 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 REGISTRATION: ClinicalTrials.gov NCT04037501 . Registered on 30 July 2019.
Entities:
Keywords:
Care management system; Caregiver health; Caregiver of people with dementia; Cluster randomised controlled trial; Unmet needs
Authors: I Zwingmann; W Hoffmann; B Michalowsky; A Dreier-Wolfgramm; J Hertel; D Wucherer; T Eichler; I Kilimann; F Thiel; S Teipel; J R Thyrian Journal: Aging Ment Health Date: 2017-11-20 Impact factor: 3.658
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Authors: Olga A Klein; Melanie Boekholt; Dilshad Afrin; Christina Dornquast; Adina Dreier-Wolfgramm; Armin Keller; Bernhard Michalowsky; Ina Zwingmann; Stefan Teipel; Jochen René Thyrian; Ingo Kilimann; Wolfgang Hoffmann Journal: Trials Date: 2021-07-06 Impact factor: 2.279