DementiaGAINNCT04037501
Effectiveness of a Care Management System to Reduce Unmet Needs of Informal Caregivers of People With Dementia
A study testing Care Management in people with Dementia and Caregiver Burnout, run by German Center for Neurodegenerative Diseases (DZNE) at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Caregiver Burnout, Carer Stress Syndrome
- What is being tested?
- Care Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteGermany
- Study dates
- 9 Oct 2020to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years
- main caregiver of a PwD (Hauptversorgungsperson)
- PwD lives at home
- written informed consent of caregiver
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
German Center for Neurodegenerative Diseases (DZNE)
Greifswald, Mecklenburg-Vorpommern, 17489
About this study
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"
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.
Read the 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
- Conditions
- Dementia, Caregiver Burnout, Carer Stress Syndrome, Relatives, Partner, Domestic
- Being tested
- Care Management
- Keywords
- Caregiver of people with dementia, Caregiver health, Care management system, Collaborative care, Informal care coordination, Dementia, Medical management, Unmet needs
- Medical subject headings
- Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care ManagementOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Care Management |
| care as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of Unmet Needs
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.
Measured: 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
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.
Measured: Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]
Secondary outcomes (3)
Change in Caregiver Burden
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.
Measured: Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]
Social Support
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.
Measured: 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
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.
Measured: : Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start9 Oct 2020
- Primary completion31 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)
- Sponsor type
- University, hospital or other
- Collaborators
- Gemeinsamer Bundesaussschuss, University Medicine Greifswald
- Responsible party
- Principal investigator, Wolfgang Hoffmann, German Center for Neurodegenerative Diseases (DZNE)
- Investigators
- Wolfgang Hoffmann, MD, Principal investigator, German Center for Neurodegenerative Diseases (DZNE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037501
- Sponsor's protocol ID
- GR009
- Other IDs
- 01VSF18030
- Acronym
- GAIN
- Status last verified
- Mar 2023
- First submitted
- 26 Jul 2019
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34134744
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT04037501
- Acronym / sponsor ID
- GAIN / GR009
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)University, hospital or other
- Collaborators
- Gemeinsamer Bundesaussschuss, University Medicine Greifswald
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Care Management |
| care as usual | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18+ years
- main caregiver of a PwD (Hauptversorgungsperson)
- PwD lives at home
- written informed consent of caregiver
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care ManagementA 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 | Other | Intervention |
Primary outcome
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.
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.
3 secondary outcomes
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)]
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)
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)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Derived from this study: PubMed 34134744Klein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Hoffmann, MD principal investigator
German Center for Neurodegenerative Diseases (DZNE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Management in people with Dementia and Caregiver Burnout, run by German Center for Neurodegenerative Diseases (DZNE) at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04037501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.