- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04037501
Effectiveness of a Care Management System to Reduce Unmet Needs of Informal Caregivers of People With Dementia (GAIN)
March 16, 2023 updated by: Wolfgang Hoffmann, German Center for Neurodegenerative Diseases (DZNE)
"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"
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
192
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mecklenburg-Western Pomerania
-
Greifswald, Mecklenburg-Western Pomerania, Germany, 17489
- German Center for Neurodegenerative Diseases (DZNE)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
|
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
|
No Intervention: care as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in number of Unmet Needs
Time Frame: Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)
|
A standardized assessment implemented as computer-assisted intervention management system (CMS) addresses caregiver burden, medical needs, home care needs, psychosocial needs (depression, sleep quality, pain, hearing, seeing, teeth problems, dementia related problems caused by PwD, medical aids).
Based on predefined algorithms the CMS will generate a list of recommended intervention to address each of the unmet needs.
|
Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)
|
Change in Quality of Life
Time Frame: Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]
|
The questionnaire SF-12 (Short form of SF-36) will be used to assess quality of life.
The SF-12 is a physical scale score that represents general health perception, physical functioning, physical role functioning, and pain.
The mental health score represents emotional role functioning, mental well-being, negative affectivity, and social functioning.
The mean score is set to 50.
Scores higher than 50 indicate better physical or mental health than the mean while scores lower than 50 indicate worse physical mental health than the mean.
|
Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Caregiver Burden
Time Frame: Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]
|
Informal caregiver burden will be assessed using the 7-item (short) version of the Zarit-Burden Interview; ZBI-7.
The short version ZBI is a caregiver self-report measure to examine burden which is associated with functional/behavioural impairments in the social, psychological and physiological context and home care situation.It contains 7 items using a 5-point scale.
Response options range from 0 (Never) to 4 (Nearly/Always).
Total scores range from 0 indicating low burden to 88 indicating high burden.
|
Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]
|
Social Support
Time Frame: Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)
|
Social support will be assessed using the Lubben Social Network Scale (LSNS).
This scale is a self-report measure of social engagement including family and friends on a 12 item scale.
Total scores ranging from 0 to 90.
High scores indicate strong social networks.
|
Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)
|
Use of medical and non-medical services
Time Frame: : Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]
|
The use of medical and non-medical services will be assessed using the Questionnaire for the Use of Medical and Non-Medical Services in Old Age [Fragebogen zur Inanspruchnahme medizinischer und nicht-medizinischer Versorgungsleistungen im Alter".
The FIMA examines socio-economic variables and other medical factors to determine health-related costs.
|
: Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wolfgang Hoffmann, MD, German Center for Neurodegenerative Diseases (DZNE)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 9, 2020
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
March 1, 2023
Study Registration Dates
First Submitted
July 26, 2019
First Submitted That Met QC Criteria
July 26, 2019
First Posted (Actual)
July 30, 2019
Study Record Updates
Last Update Posted (Actual)
March 17, 2023
Last Update Submitted That Met QC Criteria
March 16, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GR009
- 01VSF18030 (Other Grant/Funding Number: Gemeinsamer Bundesausschuss (GBA))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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