DementiaNCT01459783
Comparative Effectiveness of Dementia Care Strategies in Underserved Communities
A study testing Dementia care management in people with Dementia, run by RAND at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Dementia care management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Olive View-UCLA Medical Center
Sylmar, California, 91342-1495
About this study
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.
- Conditions
- Dementia
- Being tested
- Dementia care management
- Keywords
- Caregivers, Comparative Effectiveness Research, Cost Effectiveness, Patient Care Management, Social Work
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia care managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dementia care management in person | Active comparator | 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. Receives: Behavioral: Dementia care management |
| Dementia care management telephone only | Active comparator | 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. Receives: Behavioral: Dementia care management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Caregiver Burden at 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.
Measured: 0, 6 and 12 months
Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months
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.
Measured: 0, 6 and 12 months
Secondary outcomes (4)
Change in Caregiver Depression at 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).
Measured: 0, 6 and 12 months
Change in Caregiver Quality of Life at 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.
Measured: 0, 6 and 12 months
Change in Care Recipient Quality of Life at 6 and 12 Months
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.
Measured: 0, 6 and 12 months
Change in Process Measures of Dementia Care Quality at 6 and 12 Months
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.
Measured: 0, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Olive View-UCLA Education & Research Institute, Alzheimer's Association, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Joshua Chodosh, M.D., MSHS, Principal investigator, RANDBarbara Vickrey, M.D., MPH, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459783
- Sponsor's protocol ID
- HQ217RC4
- Other IDs
- 1RC4AG038804-01
- Status last verified
- May 2015
- First submitted
- 18 Jan 2011
- Last updated
- 22 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chodosh J, Colaiaco BA, Connor KI, Cope DW, Liu H, Ganz DA, Richman MJ, Cherry DL, Blank JM, Carbone Rdel P, Wolf SM, Vickrey BG. Dementia Care Management in an Underserved Community: The Comparative Effectiveness of Two Different Approaches. J Aging Health. 2015 Aug;27(5):864-93. doi: 10.1177/0898264315569454. Epub 2015 Feb 4.
PubMed 25656074
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Dementia Care Strategies in Underserved Communities
- ClinicalTrials.gov ID
- NCT01459783
- Acronym / sponsor ID
- HQ217RC4
- Conditions
- Dementia
- Keywords
- Caregivers, Comparative Effectiveness Research, Cost Effectiveness, Patient Care Management, Social Work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Olive View-UCLA Education & Research Institute, Alzheimer's Association, National Institute on Aging (NIA)
- Study start
- Mar 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Posted 22 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dementia care management in person | Active comparator | Behavioral: Dementia care managementThe 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. |
| Dementia care management telephone only | Active comparator | Behavioral: Dementia care managementThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Dementia care managementCare 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. | Behavioural | Dementia care management in person, Dementia care management telephone only |
Primary outcome
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.
Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months
Time frame: 0, 6 and 12 months
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.
4 secondary outcomes
Change in Caregiver Depression at 6 and 12 Months
Time frame: 0, 6 and 12 months
Change in Caregiver Quality of Life at 6 and 12 Months
Time frame: 0, 6 and 12 months
Change in Care Recipient Quality of Life at 6 and 12 Months
Time frame: 0, 6 and 12 months
Change in Process Measures of Dementia Care Quality at 6 and 12 Months
Time frame: 0, 6 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25656074Chodosh J, Colaiaco BA, Connor KI, Cope DW, Liu H, Ganz DA, Richman MJ, Cherry DL, Blank JM, Carbone Rdel P, Wolf SM, Vickrey BG. Dementia Care Management in an Underserved Community: The Comparative Effectiveness of Two Different Approaches. J Aging Health. 2015 Aug;27(5):864-93. doi: 10.1177/0898264315569454. Epub 2015 Feb 4.
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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.
Joshua Chodosh, M.D., MSHS principal investigator
RAND
Barbara Vickrey, M.D., MPH principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia care management in people with Dementia, run by RAND at 1 site in United States.
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 7 inclusion and 2 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 22 May 2015. 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 United States. 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?
Yes. Results are posted in the registry (first posted 22 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Caregiver Burden at 6 and 12 Months (time frame: 0, 6 and 12 months). 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 NCT01459783, 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 22 May 2015.