Dyadic, App-supported Collaborative Care Intervention Trial for Family Caregivers of People Living With Dementia

NCT07251088 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 554

Last updated 2025-11-26

No results posted yet for this study

Summary

In Germany, approximately 1.8 million individuals are living with dementia, representing a considerable share of those requiring long-term care. Many people with dementia (PlwD) express the desire to remain in their home environment for as long as possible. However, the progressive cognitive and physical decline associated with the disease renders caregiving increasingly time-intensive and places a substantial burden on family members. In the absence of sufficient support structures, maintaining home-based care becomes difficult, creating additional strain on the health care system.

The study aims to address these challenges through an innovative intervention. Its primary objectives are: (1) to evaluate whether a dyadic care management model, delivered by specialized nurses with expertise in dementia care and supported by a mobile health application that provides direct access to caregiving experts and memory clinics, can help stabilize the home care situation; (2) to determine whether this approach reduces caregiver burden; and (3) to assess its effectiveness in alleviating neuropsychiatric symptoms in PlwD, compared to usual care.

Conditions

  • Dementia
  • Nurse Care Coordination
  • Informal Caregiver

Interventions

OTHER

Experimental arm

Dyads in the intervention group will receive individualized dementia care management over a twelve-month period, with the objective of identifying and effectively addressing the unmet needs of people living with dementia (PlwD) and their caregivers. The intervention is complemented by a mobile health application used by both caregivers and Care Specialists, providing caregivers with continuous access to care managers and memory clinics whenever challenges or burdens arise. The app facilitates ongoing monitoring of caregivers' health status and burden through regular real-time data collection, aggregation, and transmission to the care manager, thereby enabling timely and needs-based interventions or re-interventions. Consequently, the frequency and intensity of the intervention are tailored to the dyads' individual circumstances and reported levels of burden.

Sponsors & Collaborators

  • University Medicine Rostock, Rostock

    collaborator UNKNOWN
  • AGAPLESION ELISABETHENSTIFT gGmbH

    collaborator UNKNOWN
  • AOK - Die Gesundheitskasse für Niedersachsen

    collaborator UNKNOWN
  • Gemeinnützige Gesellschaft für Psychiatrie Reutlingen mbH

    collaborator UNKNOWN
  • Georg-August-Universität Göttingen

    collaborator UNKNOWN
  • IKK gesund plus

    collaborator UNKNOWN
  • Karlsruher Institut für Technologie

    collaborator UNKNOWN
  • Otto-von-Guericke-Universität Magdeburg

    collaborator UNKNOWN
  • Universität Konstanz

    collaborator UNKNOWN
  • Universität zu Köln

    collaborator UNKNOWN
  • University Medicine Greifswald

    collaborator OTHER
  • Federal Joint Committee

    collaborator OTHER_GOV
  • German Center for Neurodegenerative Diseases (DZNE)

    lead OTHER

Principal Investigators

  • Bernhard Michalowsky, PD Dr. Dr. · German Center for Neurodegenerative Diseases (DZNE)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-06-30
Completion
2028-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07251088 on ClinicalTrials.gov