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.
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
not able to provide written consent
if a legal representative is present, they may give their consent
Parallel
Experimental arm
Other interventionDyads 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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
German Center for Neurodegenerative Diseases (DZNE)
Lead sponsor
University Medical Center 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
Karlsruhe Institute of Technology
Collaborator
Otto-von-Guericke-Universität Magdeburg
Collaborator
Universität Konstanz
Collaborator
Universität zu Köln
Collaborator
University Medicine Greifswald
Collaborator
Federal Joint Committee
Collaborator
