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1000 Titel
  • 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)
1000 Autor/in
  1. Klein, Olga A. |
  2. Boekholt, Melanie |
  3. Afrin, Dilshad |
  4. Dornquast, Christina |
  5. Dreier-Wolfgramm, Adina |
  6. Keller, Armin |
  7. Michalowsky, Bernhard |
  8. Zwingmann, Ina |
  9. Teipel, Stefan |
  10. Thyrian, Jochen René |
  11. Kilimann, Ingo |
  12. Hoffmann, Wolfgang |
1000 Erscheinungsjahr 2021
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2021-06-16
1000 Erschienen in
1000 Quellenangabe
  • 22(1):401
1000 Copyrightjahr
  • 2021
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1186/s13063-021-05290-w |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8206900/ |
1000 Publikationsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • 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.
1000 Sacherschließung
lokal Surveys and Questionnaires [MeSH]
lokal Caregiver of people with dementia
lokal Cost-Benefit Analysis [MeSH]
lokal Aged [MeSH]
lokal Study Protocol
lokal Caregiver health
lokal Humans [MeSH]
lokal Care management system
lokal Caregivers [MeSH]
lokal Dementia/diagnosis [MeSH]
lokal Cluster randomised controlled trial
lokal Randomized Controlled Trials as Topic [MeSH]
lokal Quality of Life [MeSH]
lokal Dementia/therapy [MeSH]
lokal Social Support [MeSH]
lokal Unmet needs
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0002-7159-4294|https://frl.publisso.de/adhoc/uri/Qm9la2hvbHQsIE1lbGFuaWU=|https://frl.publisso.de/adhoc/uri/QWZyaW4sIERpbHNoYWQ=|https://frl.publisso.de/adhoc/uri/RG9ybnF1YXN0LCBDaHJpc3RpbmE=|https://frl.publisso.de/adhoc/uri/RHJlaWVyLVdvbGZncmFtbSwgQWRpbmE=|https://frl.publisso.de/adhoc/uri/S2VsbGVyLCBBcm1pbg==|https://frl.publisso.de/adhoc/uri/TWljaGFsb3dza3ksIEJlcm5oYXJk|https://frl.publisso.de/adhoc/uri/WndpbmdtYW5uLCBJbmE=|https://frl.publisso.de/adhoc/uri/VGVpcGVsLCBTdGVmYW4=|https://frl.publisso.de/adhoc/uri/VGh5cmlhbiwgSm9jaGVuIFJlbsOp|https://frl.publisso.de/adhoc/uri/S2lsaW1hbm4sIEluZ28=|https://frl.publisso.de/adhoc/uri/SG9mZm1hbm4sIFdvbGZnYW5n
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