Clinical trial NCT04037501: Effectiveness of a Care Management System to Reduce Unmet Needs of Informal Caregivers of People With Dementia
Official title: "Care Management for Caregivers of People With Dementia: Effectiveness of a Care Management System to Reduce Unmet Needs of Informal Caregivers of People With Dementia"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Caregiver Burnout
Carer Stress Syndrome
Relatives
Partner, Domestic
Keywords: Caregiver of people with dementia
Caregiver health
Care management system
Collaborative care
Informal care coordination
Dementia
Medical management
Unmet needs
Lead sponsor: German Center for Neurodegenerative Diseases (DZNE)
Sponsor class: OTHER
Collaborators: name: Gemeinsamer Bundesausschuss (GBA)
name: University Medicine Greifswald
First posted: 2019-07-30
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test the effectiveness of a computer assisted care management system to identify and reduce unmet needs for and to improve quality of life of informal caregivers of people with dementia.

Detailed description: The identification of care needs of informal caregivers of people with dementia (PwD) at home is of particular importance to provide timely appropriate support and health care services to this vulnerable group. Family doctors and specialists have a key role in identifying the burden and care needs of informal caregivers. However, this often remains a challenge in everyday practice. In addition, the regionally available support and health care offers are often unknown. A computer-assisted care management system (CMS) can support the identification of unmet care needs and suggest individual, regional offers via a constantly updated database. On the basis of a standardized self-assessment, the VMS identifies personal, social, nursing and medical care needs of informal caregivers of PwD. The investigators apply the system in family and specialist practices as well as in memory clinics where it generates modularized recommendations for interventions based on predefined algorithms. The aim of the study is to test the effectiveness of a CMS to reduce the number of unmet care needs and to improve quality of life of informal caregivers of PwD. The study design is a cluster-randomized, controlled intervention study with two arms and two assessment times. The setting includes family and specialist practices for neurology and/ or psychiatry as well as memory clinics. The CMS will be used in the practices of the intervention group. Informal caregivers of PwD answer a self-administered questionnaire on a tablet PC. From the input, the system generates a list of unmet care needs based on predefined algorithms, and assigns these to individual intervention recommendations. The doctor evaluates each recommendation and forwards a validated list and possibly further intervention recommendations to a study assistant (Care Manager, CM). In a subsequent home visit, the care manager systematically collects additional information, specifies and concretizes the intervention recommendations and supports the informal caregivers of PwD in the implementation of the recommendations. In subsequent telephone contacts, the status of the implementation of the intervention recommendations will be discussed and the care manager coordinates the informal caregivers individual support. Patients of the control group will receive Care as Usual (CAU). After 6 months, a blinded, systematic, computer-based follow-up assessment will be conducted in both groups by hitherto uninvolved study assistants

Eligibility criteria: Inclusion Criteria:

* 18+ years
* main caregiver of a PwD (Hauptversorgungsperson)
* PwD lives at home
* written informed consent of caregiver

Exclusion Criteria:

* caregiver not living in the study region MV
* not able to provide written consent
* unable to fill out self-administered questionnaire an/or to be interviewed

Primary outcomes:
measure: Change in number of Unmet Needs
timeFrame: Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)
measure: Change in Quality of Life
timeFrame: Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]
Secondary outcomes:
measure: Change in Caregiver Burden
timeFrame: Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]
measure: Social Support
timeFrame: Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)
measure: Use of medical and non-medical services
timeFrame: : Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: German Center for Neurodegenerative Diseases (DZNE)
state: Mecklenburg-Western Pomerania
Study officials:
affiliation: German Center for Neurodegenerative Diseases (DZNE)
name: Wolfgang Hoffmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klein OA, Boekholt M, Afrin D, Dornquast C, Dreier-Wolfgramm A, Keller A, Michalowsky B, Zwingmann I, Teipel S, Thyrian JR, Kilimann I, Hoffmann W. Effectiveness of a digitally supported care management programme to reduce unmet needs of family caregivers of people with dementia: study protocol for a cluster randomised controlled trial (GAIN). Trials. 2021 Jun 16;22(1):401. doi: 10.1186/s13063-021-05290-w.