Effectiveness of a Care Management System to Reduce Unmet Needs of Informal Caregivers of People With Dementia

NCT ID: NCT04037501

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-09

Study Completion Date

2023-03-01

Brief Summary

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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

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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

Conditions

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Dementia Caregiver Burnout Carer Stress Syndrome Relatives Partner, Domestic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Group Type EXPERIMENTAL

Care Management

Intervention Type OTHER

A computerized Care Management System (CMS) will identify unmet needs of the informal caregiver of PwD and generates suggestions for interventions. Based on these, the treating physician develops an individualized treatment and care plan and assigns specific tasks to the care manager. Upon a home visit in the caregivers' home the care manager evaluates the need for additional tasks. Based on the complete list of tasks, the care manager initiates the implementation of respective actions. Via monthly telephone calls and optional home visits the care manager monitors the status of implementation and actively coordinates the support and care for the informal caregiver recommended intervention

care as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Care Management

A computerized Care Management System (CMS) will identify unmet needs of the informal caregiver of PwD and generates suggestions for interventions. Based on these, the treating physician develops an individualized treatment and care plan and assigns specific tasks to the care manager. Upon a home visit in the caregivers' home the care manager evaluates the need for additional tasks. Based on the complete list of tasks, the care manager initiates the implementation of respective actions. Via monthly telephone calls and optional home visits the care manager monitors the status of implementation and actively coordinates the support and care for the informal caregiver recommended intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gemeinsamer Bundesausschuss (GBA)

UNKNOWN

Sponsor Role collaborator

University Medicine Greifswald

OTHER

Sponsor Role collaborator

German Center for Neurodegenerative Diseases (DZNE)

OTHER

Sponsor Role lead

Responsible Party

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Wolfgang Hoffmann

Site speaker

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wolfgang Hoffmann, MD

Role: PRINCIPAL_INVESTIGATOR

German Center for Neurodegenerative Diseases (DZNE)

Locations

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German Center for Neurodegenerative Diseases (DZNE)

Greifswald, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 34134744 (View on PubMed)

Other Identifiers

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01VSF18030

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GR009

Identifier Type: -

Identifier Source: org_study_id

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