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Comparative Effectiveness of Dementia Care Strategies in Underserved Communities

This study has been completed.
Sponsor:
Collaborators:
Olive View-UCLA Education & Research Institute
Alzheimer's Association
National Institute on Aging (NIA)
Information provided by (Responsible Party):
RAND
ClinicalTrials.gov Identifier:
NCT01459783
First received: January 18, 2011
Last updated: May 6, 2015
Last verified: May 2015
Results First Received: February 25, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition: Dementia
Intervention: Behavioral: Dementia care management

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult caregivers (CG) lived with dementia care recipient (CR) or were the main support for >6 months. CRs had to live in the community (no nursing home). Admin data (ICD-9 codes) yielded eligible CRs from Olive View Med Center+local clinics. CRs got recruitment mailings to give to CG. CG were also recruited at CR's memory clinic+community outreach

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A research assistant (RA) got informed consent either in-person at clinic or by phone for outreach/admin data sources. Contact info was sent to the survey group who completed enrollment and a baseline survey; then participants were randomized by the RA. Between the survey and randomization, 3 CGs were found ineligible and 4 duplicates were found.

Reporting Groups
  Description
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.

Dementia care management: 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.

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.

Dementia care management: 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 and proactive follow-up.


Participant Flow for 2 periods

Period 1:   Baseline to 6 Months
    Dementia Care Management in Person   Dementia Care Management Telephone Only
STARTED   71   73 
COMPLETED   39   53 
NOT COMPLETED   32   20 
Death                1                0 
Withdrawal by Subject                12                6 
Lost to Follow-up                19                14 

Period 2:   6 Months to 12 Months
    Dementia Care Management in Person   Dementia Care Management Telephone Only
STARTED   39   53 
COMPLETED   20   23 
NOT COMPLETED   19   30 
Death                0                1 
Withdrawal by Subject                6                5 
Lost to Follow-up                2                7 
Study ended before 12-month follow-up                11                17 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Dementia care management: 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.

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.

Dementia care management: 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 and proactive follow-up.

Total Total of all reporting groups

Baseline Measures
   Dementia Care Management in Person   Dementia Care Management Telephone Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 71   73   144 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 48.07  (14.28)   50.95  (12.71)   49.53  (13.53) 
[1] This is the caregiver age.
Gender [1] 
[Units: Participants]
     
Female   48   46   94 
Male   23   27   50 
[1] This is the caregiver's gender
Race/Ethnicity, Customized [1] 
[Units: Participants]
     
African American   6   3   9 
Caucasian or Euro-American   7   6   13 
Hispanic or Latino   52   60   112 
Other   6   4   10 
[1] This is the caregiver's race/ethnicity
Education [1] 
[Units: Participants]
     
Less than high school   25   27   52 
High school graduate or GED   19   13   32 
Some college or 2-year degree   12   22   34 
4-year college or more   15   11   26 
[1] This is the caregiver's educational attainment
Language spoken with friends and family [1] 
[Units: Participants]
     
English   25   24   49 
Spanish   39   46   85 
Other   7   3   10 
[1] This is the caregiver's language spoken with friends and family
Relationship type to care recipient [1] 
[Units: Participants]
     
Spouse   9   16   25 
Son/Daughter   36   41   77 
Brother/sister   1   1   2 
Cousin/other relative   6   1   7 
Other   19   14   33 
[1] This is the caregiver's relationship to the care recipient/person with dementia.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Caregiver Burden at 6 and 12 Months   [ Time Frame: 0, 6 and 12 months ]

2.  Primary:   Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months   [ Time Frame: 0, 6 and 12 months ]

3.  Secondary:   Change in Caregiver Depression at 6 and 12 Months   [ Time Frame: 0, 6 and 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Change in Caregiver Quality of Life at 6 and 12 Months   [ Time Frame: 0, 6 and 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Change in Care Recipient Quality of Life at 6 and 12 Months   [ Time Frame: 0, 6 and 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Change in Process Measures of Dementia Care Quality at 6 and 12 Months   [ Time Frame: 0, 6 and 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Joshua Chodosh or Barbara Vickrey
Organization: University of California Los Angeles
phone: 310-206-7671
e-mail: jchodosh@mednet.ucla.edu


Publications of Results:

Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT01459783     History of Changes
Other Study ID Numbers: HQ217RC4
1RC4AG038804-01 ( US NIH Grant/Contract Award Number )
Study First Received: January 18, 2011
Results First Received: February 25, 2015
Last Updated: May 6, 2015
Health Authority: United States: Institutional Review Board