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Background <p>Informal caregivers provide a large part of the care required by people living with dementia. With disease progression, the burden on caregivers typically increases. Dyadic interventions, addressing both the caregiver and the person living with dementia simultaneously, can help to stabilize home care settings. This study examines the effectiveness and cost-effectiveness of an app-assisted dementia care intervention.</p> Methods <p><i>Living@home</i> is a two-arm, randomized, controlled, multi-center interventional study designed to evaluate the effectiveness of a dyadic, app-based intervention on home care stability as well as the cost-effectiveness of this approach. The inclusion criteria are a formal diagnosis of dementia and living in their own home for the person with dementia, as well as access to a smartphone and internet for the informal caregiver. A total of 554 dyads will be recruited in five participating memory clinics and randomized (1:1 ratio, using block randomization) into either the intervention or the control group. The intervention group will receive personalized dementia care management for a period of 12 months. A mobile health app connecting caregivers with a Family Care Specialist offers informal caregivers access to memory clinics and Care Specialists at any time, monitoring of their health situation through real-time data collection, overview of care-related tasks, information and alerts tailored to the reported individual caregiver burden. The control group receives care-as-usual. Both groups will be assessed at baseline and after 12 months. The primary outcome is the caregiver’s perseverance time (Perseverance Time Scale), and crucial secondary supportive outcomes are neuropsychiatric symptoms in the person living with dementia (Neuropsychiatric Inventory), and the caregiver’s perceived burden (Zarit Burden Interview). Further secondary outcomes include the caregiver’s resilience and self-efficacy, the dyads’ physiological stress level (as measured by hair cortisol concentrations), health-related quality of life, caregiver depression and anxiety, dyads’ unmet needs, and cost-effectiveness. Intervention effects will be estimated by using multivariate regression analyses.</p> Discussion <p>Evidence on the effectiveness and cost-effectiveness of the intervention created from this study can help to inform decision makers and support the transition of the intervention to standard care.</p> Trial registration <p>ClinicalTrials.gov NCT07251088, Registered&#xa0;25.11.2025</p>

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Protocol of a dyadic, app-supported collaborative care intervention trial for informal caregivers of people living with dementia—the multi-center living@home study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月18日

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  • Eva Gläser,
  • Fabian Kleinke,
  • Milena Armanowski,
  • Maresa Buchholz,
  • Andreas Fellgiebel,
  • Marius Gerdes,
  • Wolfgang Hoffmann,
  • Bernhard Holle,
  • Ingo Kilimann,
  • Kerstin Köhler,
  • Stefanie Köhler,
  • Franziska Maier,
  • Ingo Matthäus,
  • Nils Pfeuffer,
  • Anika Rädke,
  • Dorota Sarwinska,
  • Björn H. Schott,
  • Frank Schwärzler,
  • Enno Swart,
  • Stefan Teipel,
  • Neeltje van den Berg,
  • Tim Wendisch,
  • Jens Wiltfang,
  • Alexandra Wuttke,
  • Bernhard Michalowsky

摘要

Background

Informal caregivers provide a large part of the care required by people living with dementia. With disease progression, the burden on caregivers typically increases. Dyadic interventions, addressing both the caregiver and the person living with dementia simultaneously, can help to stabilize home care settings. This study examines the effectiveness and cost-effectiveness of an app-assisted dementia care intervention.

Methods

Living@home is a two-arm, randomized, controlled, multi-center interventional study designed to evaluate the effectiveness of a dyadic, app-based intervention on home care stability as well as the cost-effectiveness of this approach. The inclusion criteria are a formal diagnosis of dementia and living in their own home for the person with dementia, as well as access to a smartphone and internet for the informal caregiver. A total of 554 dyads will be recruited in five participating memory clinics and randomized (1:1 ratio, using block randomization) into either the intervention or the control group. The intervention group will receive personalized dementia care management for a period of 12 months. A mobile health app connecting caregivers with a Family Care Specialist offers informal caregivers access to memory clinics and Care Specialists at any time, monitoring of their health situation through real-time data collection, overview of care-related tasks, information and alerts tailored to the reported individual caregiver burden. The control group receives care-as-usual. Both groups will be assessed at baseline and after 12 months. The primary outcome is the caregiver’s perseverance time (Perseverance Time Scale), and crucial secondary supportive outcomes are neuropsychiatric symptoms in the person living with dementia (Neuropsychiatric Inventory), and the caregiver’s perceived burden (Zarit Burden Interview). Further secondary outcomes include the caregiver’s resilience and self-efficacy, the dyads’ physiological stress level (as measured by hair cortisol concentrations), health-related quality of life, caregiver depression and anxiety, dyads’ unmet needs, and cost-effectiveness. Intervention effects will be estimated by using multivariate regression analyses.

Discussion

Evidence on the effectiveness and cost-effectiveness of the intervention created from this study can help to inform decision makers and support the transition of the intervention to standard care.

Trial registration

ClinicalTrials.gov NCT07251088, Registered 25.11.2025