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

NCT07251088 | Not Yet Recruiting

• 1 other identifier: 01NVF24315
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 12

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.

Conditions

Dementia; Nurse Care Coordination; Informal Caregiver

Keywords

Dementia; Dementia Care; Caregiver of people with dementia; Dyade; digital health intervention

Outcome Measures

Primary Outcomes (3)

• Stability of the home care arrangement (Perseverance Time Scale)

  For the Perseverance Time Scale, informal caregivers are asked (self-assessment) to estimate how long they believe they can continue to provide informal care and, thus, their current care situation. Response options are: less than one week, less than one month, less than six months, less than one year, less than two years, and two years or more. This measure is central to evaluating the long-term stability of home-based care - an essential aspect of dementia care, given the chronic and progressive nature of the disease.

  12 months after baseline assessment

• Neuropsychiatric symptoms (NPI-Q)

  Another primary outcome is the presence of neuropsychiatric symptoms in PlwD, assessed with the Neuropsychiatric Inventory Questionnaire (NPI-Q), completed by the informal caregiver via face-to-face interviews with the study nurse. Neuropsychiatric symptoms are well-documented contributors to caregiver burden, underlining the dyadic nature of selected primary outcomes. Each of the 12 domains of the NPI-Q includes a survey item that captures the key symptom associated with that domain. For each question, respondents indicate whether the symptom has been present ("Yes") or absent ("No"). If the response is "No," the informant proceeds to the next item. If "Yes," they are asked to rate the severity of the symptom experienced during the past month on a 3-point scale, as well as the caregiver distress caused by the symptom on a 5-point scale. The NPI score can becalculated by adding the scores of the first 10 ir 12 items, higher scores indicate higher presence of psychopathology.

  12 months after baseline assessment

• Caregiver burden (ZBI)

  The third primary outcome is the caregiver burden itself, measured via the Zarit Burden Interview (12-item version), which will be self-completed by caregivers. This tool is among the most commonly applied instruments in informal dementia caregiver research, enabling comparability across studies. While the most commonly used form of the Zarit Burden Interview is a 22-item version, the shortened 12-item version has demonstrated comparable psychometric properties (Bedard et al., 2001), offering a time-efficient alternative that reduces respondent burden. Each item on the interview is a statement which the caregiver is asked to rate using a 5-point scale. Response options range from 0 (never) to 4 (nearly always). The result of the instrument is a sum between 0 and 48, higher results indicate a higher subjective level of burden.

  12 months after baseline assessment

Study Arms (2)

Care as usual

NO INTERVENTION

Care as usual

Individualized Dementia Care Management

EXPERIMENTAL

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.

Other: Experimental arm

Interventions

Experimental arm 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.

Also known as: Individualized Dementia Care Management

Individualized Dementia Care Management

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• German Center for Neurodegenerative Diseases (DZNE): lead
• University Medicine Rostock, Rostock: collaborator
• AGAPLESION ELISABETHENSTIFT gGmbH: collaborator
• AOK - Die Gesundheitskasse für Niedersachsen: collaborator
• Gemeinnützige Gesellschaft für Psychiatrie Reutlingen mbH: collaborator
• Georg-August-Universität Göttingen: collaborator
• IKK gesund plus: collaborator
• Karlsruher Institut für Technologie: collaborator
• Otto-von-Guericke-Universität Magdeburg: collaborator
• Universität Konstanz: collaborator
• Universität zu Köln: collaborator
• University Medicine Greifswald: collaborator
• Federal Joint Committee: collaborator

Study Sites (12)

Institut für Technik der Informationsverarbeitung

Karlsruhe, Baden-Wurttemberg, 76131, Germany

Location

Universität Konstanz

Konstanz, Baden-Wurttemberg, 78464, Germany

Location

Gemeinnützige Gesellschaft für Psychiatrie Reutlingen mbh

Reutlingen, Baden-Wurttemberg, 72764, Germany

Location

AGAPLESION Elisabethenstift

Darmstadt, Hesse, 64287, Germany

Location

AOK Niedersachsen

Hanover, Lower Sachsony, 30173, Germany

Location

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location

Universitätsmedizin Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

DZNE

Greifswald, Mecklenburg-Vorpommern, 17487, Germany

Location

Universitätsmedizin Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Universität zu Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Otto-von-Guericke-Universität Magdeburg

Magdeburg, Saxony, 39120, Germany

Location

IKK gesund plus

Magdeburg, Saxony, 39124, Germany

Location

Related Publications (8)

• 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.

  PMID: 40148225 BACKGROUND

• 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.

  PMID: 26890767 BACKGROUND

• 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.

  PMID: 25125471 BACKGROUND

• 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.

  PMID: 12021425 BACKGROUND

• 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.

  PMID: 7203086 BACKGROUND

• 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.

  PMID: 23184421 BACKGROUND

• 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.

  PMID: 38669533 BACKGROUND

• 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.

  PMID: 35410437 BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Bernhard Michalowsky, PD Dr. Dr.

  German Center for Neurodegenerative Diseases (DZNE)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernhard Michalowsky, PD Dr. Dr.

CONTACT

+49 3834 86-8530; bernhard.michalowsky@dzne.de

Eva Gläser

CONTACT

+49 3834 86 8534; eva.glaeser@dzne.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Group leader

Model Details: Specially qualified nurses (caregiver experts) will provide individualized dementia care management to dyads in the intervention group over a period of twelve months, with the aim of identifying and effectively addressing the unmet needs of both people living with dementia (PlwD) and their caregivers.

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: November 26, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (12)