- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01459783
Comparative Effectiveness of Dementia Care Strategies in Underserved Communities
May 6, 2015 updated by: RAND
Dementia is a condition that is growing in prevalence and which harms not only the afflicted individual but also adversely affects the health of their family and other informal caregivers.
New methods for delivering comprehensive assistance to persons with dementia and their caregivers are known to be effective and can delay nursing home placement, but this study will discover 1) whether more face-to-face involvement rather than telephone delivery of this assistance will work better among poor patients in Los Angeles, and 2) if one method is better than the other, what are the differences in costs between them.
These data will enable administrators in public health care settings around the US and non-profit foundations addressing dementia patient and caregiver needs to decide what method provides the best value and the best outcome relative to its cost.
Study Overview
Study Type
Interventional
Enrollment (Actual)
144
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
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California
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Sylmar, California, United States, 91342-1495
- Olive View-UCLA Medical Center
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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
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Caregivers of persons with dementia
- Caregivers must either live with the care recipient (person with dementia) or be the identified primary support
- Caregiver relationship must have been present for the prior 6 months
- Caregivers must have telephone access
- Caregivers must speak English or Spanish
- Care recipients must have a prior dementia diagnosis
- Care recipients must be living in the community other than a nursing facility
Exclusion Criteria:
- Persons with dementia, lacking an informal caregiver who can communicate in Spanish or English, or living in a long term care facility
- Caregiver lacks the capacity to consent to study participation
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dementia care management in person
The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.
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Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues.
Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems.
An electronic tracking tool and resource manual guide delivery of the care management protocols.
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Active Comparator: Dementia care management telephone only
The dementia care management protocol will be delivered via telephonic meetings only.
Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.
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Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues.
Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems.
An electronic tracking tool and resource manual guide delivery of the care management protocols.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Caregiver Burden at 6 and 12 Months
Time Frame: 0, 6 and 12 months
|
The Zarit Burden Interview (BI) is a widely used validated measure to assess stressors experienced by caregivers of persons with dementia.
Originally a 29-item instrument, the 22-item modified version is easily completed by telephone.
This instrument covers five constructs of burden: health, psychological well-being, finances, social life, and relationship with impaired person and an overall summary score of caregiver burden.
Higher Zarit scores indicate greater caregiver burden.
The minimum possible score is 0, and the maximum possible score is 110.
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0, 6 and 12 months
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Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months
Time Frame: 0, 6 and 12 months
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The Revised Memory and Behavior Problem Checklist (RMBPC) was developed by Teri and colleagues.
The RMBPC instrument assess 24 care receiver problems in the areas of behavior, memory, and depression and whether each behavior had occurred in the prior week.
Higher RMBPC scores mean worse memory/behavior problems.
The minimum possible score for number of problems is zero, and the maximum score for number of problems is 24.
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0, 6 and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Caregiver Depression at 6 and 12 Months
Time Frame: 0, 6 and 12 months
|
The Patient Health Questionnaire - Nine (PHQ-9) is a 9-item self-report measure of depressive symptoms over the previous 2 weeks.
The PHQ-9 is the depression module of the PRIME- MD diagnostic instrument for common mental disorders.
It covers each of the 9 DSM-IV depression criteria scoring them as "0" (not at all) to "3" (nearly every day).
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0, 6 and 12 months
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Change in Caregiver Quality of Life at 6 and 12 Months
Time Frame: 0, 6 and 12 months
|
The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia, incorporates non-health related issues as well as positive aspects of caregiving, and has demonstrated feasibility as a phone-based instrument in both English and Spanish.
Eighty items are distributed across 10 scales: assistance with ADLs, assistance with IADLs, personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving.
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0, 6 and 12 months
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Change in Care Recipient Quality of Life at 6 and 12 Months
Time Frame: 0, 6 and 12 months
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The investigators will evaluate patient health-related quality of life (HRQOL) by proxy (caregiver) assessment using the 15-item Health Utilities Index (HUI2), a generic health state classification system with preference-based utility weights derived from the general population.
The HUI is one of the more widely used utility measures and has been used in previous studies of elderly with dementia and their caregivers.
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0, 6 and 12 months
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Change in Process Measures of Dementia Care Quality at 6 and 12 Months
Time Frame: 0, 6 and 12 months
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The investigators will collect caregiver survey identified care process measures to assess which medical care processes that are specific to dementia occurred as a potential mediator of change in outcomes.
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0, 6 and 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joshua Chodosh, M.D., MSHS, RAND
- Principal Investigator: Barbara Vickrey, M.D., MPH, RAND
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
March 1, 2011
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
January 18, 2011
First Submitted That Met QC Criteria
October 25, 2011
First Posted (Estimate)
October 26, 2011
Study Record Updates
Last Update Posted (Estimate)
May 22, 2015
Last Update Submitted That Met QC Criteria
May 6, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HQ217RC4
- 1RC4AG038804-01 (U.S. NIH Grant/Contract)
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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Clinical Trials on Dementia care management
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VA Greater Los Angeles Healthcare SystemUniversity of California, Los AngelesUnknown
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German Center for Neurodegenerative Diseases (DZNE)German Federal Ministry of Education and Research; University Medicine Greifswald and other collaboratorsCompletedNeurodegenerative Diseases | Cognitive Impairment | DementiaGermany
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German Center for Neurodegenerative Diseases (DZNE)University Medicine GreifswaldActive, not recruiting
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Corporal Michael J. Crescenz VA Medical CenterCompleted
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Kaohsiung Medical University Chung-Ho Memorial...Completed
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University of California, Los AngelesPatient-Centered Outcomes Research Institute; Yale University; University of... and other collaboratorsCompleted
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Chang Gung Memorial HospitalChang Gung University of Science and TechnologyCompleted
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Chang Gung Memorial HospitalChang Gung University of Science and Technology; National Science and Technology...Not yet recruiting