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

NCT ID: NCT07251088

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 554 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-12-31

Brief 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.

Detailed Description

In Germany, approximately 84% of the five million individuals in need of care are supported at home by informal caregivers, most commonly family members. Only 21% receive professional assistance from care or support services, highlighting the substantial responsibility placed on families. People living with dementia (PlwD) constitute a particularly large share of these care recipients. On average, they require around 36 hours of informal care per week-considerably more than individuals affected by conditions such as cancer (16 hours/week) or stroke (24 hours/week).

Both PlwD and their caregivers, often conceptualized as a dyad, frequently express a strong preference for remaining in their home environment and sustaining home-based care for as long as possible. While many caregivers provide support over extended periods and may even perceive their role as meaningful, the progressive cognitive and physical decline of PlwD, combined with neuropsychiatric symptoms and caregivers' perceived sense of obligation, can result in considerable psychological and physical strain. Such strain is commonly associated with depression, anxiety, diminished subjective well-being, reduced self-efficacy, and social withdrawal. Consequently, the sustainability of home care is often precarious. Indeed, 40% of caregivers of community-dwelling PlwD report being unable to maintain care for longer than one year, leading to institutionalization.

Although support services for caregivers have been steadily expanded in recent years, their utilization remains limited. Barriers include a lack of awareness, organizational hurdles, and, paradoxically, the high demands of caregiving itself, which can hinder access to such services. In the absence of sufficient support, informal care is increasingly substituted by professional long-term care, thereby intensifying pressure on already limited workforce and financial resources within the health care system. This transition is also frequently accompanied by feelings of guilt among caregivers.

Evidence regarding the effectiveness of interventions to support caregivers is mixed. Randomized controlled trials have only partly demonstrated significant reductions in caregiver burden. A meta-analysis indicated that individualized, structured multicomponent interventions-comprising various support modules-are most effective. While there is some evidence for cost-effectiveness, it is constrained by small sample sizes. A model-based analysis suggests that dyadic interventions, which target both PlwD and caregivers, may prolong the feasibility of home-based care and could be cost-effective. However, findings remain inconsistent: a meta-analysis of randomized controlled trials reported positive outcomes in 13 studies but no effect in 9 others. Effectiveness appears to depend strongly on the duration and intensity of interventions. One explanation may be that caregiver needs during periods of heightened burden were not adequately or promptly addressed.

Digital health interventions, such as remote, app-based solutions, offer the potential to overcome these limitations by providing flexible and immediate support at critical moments. Nevertheless, research in this field remains limited, and it is still unclear to what extent digital approaches can stabilize home care situations for PlwD and their families.

Conditions

Dementia; Nurse Care Coordination; Informal Caregiver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Care as usual

Care as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Individualized Dementia Care Management

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 realtime 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.

Group Type: EXPERIMENTAL

Experimental arm

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Individualized Dementia Care Management

Eligibility Criteria

Inclusion Criteria

• formal dementia diagnosis
• living in their own home for the person with dementia
• access to a smartphone and internet for the informal caregiver
• informed consent of the participant

Exclusion Criteria

• not able to provide written consent
• if a legal representative is present, they may give their consent

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medicine Rostock, Rostock

UNKNOWN

Sponsor Role: collaborator

AGAPLESION ELISABETHENSTIFT gGmbH

UNKNOWN

Sponsor Role: collaborator

AOK - Die Gesundheitskasse für Niedersachsen

UNKNOWN

Sponsor Role: collaborator

Gemeinnützige Gesellschaft für Psychiatrie Reutlingen mbH

UNKNOWN

Sponsor Role: collaborator

Georg-August-Universität Göttingen

UNKNOWN

Sponsor Role: collaborator

IKK gesund plus

UNKNOWN

Sponsor Role: collaborator

Karlsruher Institut für Technologie

UNKNOWN

Sponsor Role: collaborator

Otto-von-Guericke-Universität Magdeburg

UNKNOWN

Sponsor Role: collaborator

Universität Konstanz

UNKNOWN

Sponsor Role: collaborator

Universität zu Köln

UNKNOWN

Sponsor Role: collaborator

University Medicine Greifswald

OTHER

Sponsor Role: collaborator

Federal Joint Committee

OTHER_GOV

Sponsor Role: collaborator

German Center for Neurodegenerative Diseases (DZNE)

OTHER

Sponsor Role: lead

Responsible Party

Bernhard Michalowsky

Research Group leader

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernhard Michalowsky, PD Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

German Center for Neurodegenerative Diseases (DZNE)

Locations

Institut für Technik der Informationsverarbeitung

Karlsruhe, Baden-Wurttemberg, Germany

Universität Konstanz

Konstanz, Baden-Wurttemberg, Germany

Gemeinnützige Gesellschaft für Psychiatrie Reutlingen mbh

Reutlingen, Baden-Wurttemberg, Germany

AGAPLESION Elisabethenstift

Darmstadt, Hesse, Germany

AOK Niedersachsen

Hanover, Lower Sachsony, Germany

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, Germany

Universitätsmedizin Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany

DZNE

Greifswald, Mecklenburg-Vorpommern, Germany

Universitätsmedizin Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Universität zu Köln

Cologne, North Rhine-Westphalia, Germany

Otto-von-Guericke-Universität Magdeburg

Magdeburg, Saxony, Germany

IKK gesund plus

Magdeburg, Saxony, Germany

Countries

Germany

Central Contacts

Bernhard Michalowsky, PD Dr. Dr.

Role: CONTACT

bernhard.michalowsky@dzne.de

+49 3834 86-8530

Eva Gläser

Role: CONTACT

eva.glaeser@dzne.de

+49 3834 86 8534

Facility Contacts

Frank Schwärzler, Dr.

Role: primary

frank.schwaerzler@pprt.de

+49 712192000929

Andreas Fellgiebel, Univ.-Prof. Dr. med.

Role: primary

andreas.fellgiebel@agaplesion.de

+49 6151 4034001

Björn Hendrik Schott, PD Dr. Dr.

Role: primary

bjoernhendrik.schott@med.uni-goettingen.de

+49 5513963752

Stefan Teipel, Prof. Dr. med.

Role: primary

stefan.teipel@med.uni-rostock.de

+49 381494 9480

Franziska Maier, Dr.

Role: primary

franziska.maier@uk-koeln.de

+49 2214785401

References

Scharf A, Michalowsky B, Radke A, Kleinke F, Schade S, Platen M, Buchholz M, Pfaff M, Iskandar A, van den Berg N, Hoffmann W. Identifying and Addressing Unmet Needs in Dementia: The Role of Care Access and Psychosocial Support. Int J Geriatr Psychiatry. 2025 Apr;40(4):e70066. doi: 10.1002/gps.70066.

Reference Type: BACKGROUND

PMID: 40148225 (View on PubMed)

Eichler T, Thyrian JR, Hertel J, Richter S, Wucherer D, Michalowsky B, Teipel S, Kilimann I, Dreier A, Hoffmann W. Unmet Needs of Community-Dwelling Primary Care Patients with Dementia in Germany: Prevalence and Correlates. J Alzheimers Dis. 2016;51(3):847-55. doi: 10.3233/JAD-150935.

Reference Type: BACKGROUND

PMID: 26890767 (View on PubMed)

Michalowsky B, Eichler T, Thyrian JR, Hertel J, Wucherer D, Laufs S, Flessa S, Hoffmann W. Medication cost of persons with dementia in primary care in Germany. J Alzheimers Dis. 2014;42(3):949-58. doi: 10.3233/JAD-140804.

Reference Type: BACKGROUND

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Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.

Reference Type: BACKGROUND

PMID: 12021425 (View on PubMed)

Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.

Reference Type: BACKGROUND

PMID: 7203086 (View on PubMed)

Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25.

Reference Type: BACKGROUND

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Scharf A, Kleinke F, Michalowsky B, Radke A, Pfitzner S, Muhlichen F, Buchholz M, van den Berg N, Hoffmann W. Sociodemographic and Clinical Characteristics of People Living with Dementia and Their Associations with Unmet Healthcare Needs: Insights from the Baseline Assessment of the InDePendent Study. J Alzheimers Dis. 2024;99(2):559-575. doi: 10.3233/JAD-231173.

Reference Type: BACKGROUND

PMID: 38669533 (View on PubMed)

Kleinke F, Michalowsky B, Radke A, Platen M, Muhlichen F, Scharf A, Mohr W, Penndorf P, Bahls T, van den Berg N, Hoffmann W. Advanced nursing practice and interprofessional dementia care (InDePendent): study protocol for a multi-center, cluster-randomized, controlled, interventional trial. Trials. 2022 Apr 11;23(1):290. doi: 10.1186/s13063-022-06249-1.

Reference Type: BACKGROUND

PMID: 35410437 (View on PubMed)

Other Identifiers

01NVF24315

Identifier Type: -

Identifier Source: org_study_id