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Comparative Effectiveness of Dementia Care Strategies in Underserved Communities

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ClinicalTrials.gov Identifier: NCT01459783
Recruitment Status : Completed
First Posted : October 26, 2011
Results First Posted : May 22, 2015
Last Update Posted : May 22, 2015
Sponsor:
Collaborators:
Olive View-UCLA Education & Research Institute
Alzheimer's Association
National Institute on Aging (NIA)
Information provided by (Responsible Party):
RAND

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Dementia
Intervention Behavioral: Dementia care management
Enrollment 144

Recruitment Details 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 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.
Arm/Group Title Dementia Care Management in Person Dementia Care Management Telephone Only
Hide Arm/Group Description

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.

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.

Period Title: Baseline to 6 Months
Started 71 73
Completed 39 53
Not Completed 32 20
Reason Not Completed
Death             1             0
Withdrawal by Subject             12             6
Lost to Follow-up             19             14
Period Title: 6 Months to 12 Months
Started 39 53
Completed 20 23
Not Completed 19 30
Reason Not Completed
Death             0             1
Withdrawal by Subject             6             5
Lost to Follow-up             2             7
Study ended before 12-month follow-up             11             17
Arm/Group Title Dementia Care Management in Person Dementia Care Management Telephone Only Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 71 73 144
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 73 participants 144 participants
48.07  (14.28) 50.95  (12.71) 49.53  (13.53)
[1]
Measure Description: This is the caregiver age.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 73 participants 144 participants
Female
48
  67.6%
46
  63.0%
94
  65.3%
Male
23
  32.4%
27
  37.0%
50
  34.7%
[1]
Measure Description: This is the caregiver's gender
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 73 participants 144 participants
African American 6 3 9
Caucasian or Euro-American 7 6 13
Hispanic or Latino 52 60 112
Other 6 4 10
[1]
Measure Description: This is the caregiver's race/ethnicity
Education   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 73 participants 144 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]
Measure Description: This is the caregiver's educational attainment
Language spoken with friends and family   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 73 participants 144 participants
English 25 24 49
Spanish 39 46 85
Other 7 3 10
[1]
Measure Description: This is the caregiver's language spoken with friends and family
Relationship type to care recipient   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 73 participants 144 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]
Measure Description: This is the caregiver's relationship to the care recipient/person with dementia.
1.Primary Outcome
Title Change in Caregiver Burden at 6 and 12 Months
Hide Description 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.
Time Frame 0, 6 and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dementia Care Management in Person Dementia Care Management Telephone Only
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 71 73
Mean (Standard Deviation)
Unit of Measure: units on a scale
Unadjusted score at 6 months 29.99  (17.51) 30.09  (19.6)
Unadjusted score at 12 months 28.1  (18.53) 28.13  (11.84)
Baseline score 30.07  (16.99) 30.91  (17.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dementia Care Management in Person, Dementia Care Management Telephone Only
Comments Analyses were intention-to-treat. Due to attrition and those ineligible for 12-month follow-up due to study ending before that time, we created survey non-response weights for each wave. Prior to the study, a sample size of 125 participants per group was based on the two primary outcomes, with a Type I Error of 0.025 (Bonferroni adjustment), setting a 0.5-SD difference in outcomes as clinically important, 80% power, 0.45 SD difference in difference in outcomes between groups, and 25% attrition.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments We adopted Bonferroni adjustment for multiple testing and used a significance level of .05/3 = 0.017 to interpret the results for our primary outcomes.
Method Regression, Linear
Comments Multivariate analyses included non-response weights and controlled for study arm, stratification variables, baseline values, & intervention duration.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
-5.13 to 6.95
Estimation Comments The difference in differences at 12 months is reported as in-person arm minus phone arm values from a multivariable analysis. A positive adjusted difference means worse burden for the in-person arm compared to the phone arm.
2.Primary Outcome
Title Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months
Hide Description 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.
Time Frame 0, 6 and 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dementia Care Management in Person Dementia Care Management Telephone Only
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 71 73
Mean (Standard Deviation)
Unit of Measure: units on a scale
unadjusted 6 month post intervention 9.68  (5.53) 8.53  (5.33)
12 month unadjusted post-intervention 8.2  (5.86) 9.26  (5.26)
Baseline score 9.44  (4.92) 9.43  (5.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dementia Care Management in Person, Dementia Care Management Telephone Only
Comments Analyses were intention-to-treat. Due to attrition and those ineligible for 12-month follow-up due to study ending before that time, we created survey non-response weights for each wave. Prior to the study, a sample size of 125 participants per group was based on the two primary outcomes, with a Type I Error of 0.025 (Bonferroni adjustment), setting a 0.5-SD difference in outcomes as clinically important, 80% power, 0.45 SD difference in difference in outcomes between groups, and 25% attrition.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments We used Bonferroni adjustment for multiple testing and a significance level of .05/3 = 0.017 to interpret the results for our primary outcomes. The behavior measure is analyzed two ways: total number of problems (reported here), and reaction score.
Method Regression, Linear
Comments Multivariate analyses included non-response weights and controlled for study arm, stratification variables, baseline values, & intervention duration.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-1.74 to 3.55
Estimation Comments The difference in differences at 12 months is reported as in-person arm minus phone arm values from a multivariable analysis. A positive adjusted difference means worse problems for the in-person arm compared to the phone arm.
3.Secondary Outcome
Title Change in Caregiver Depression at 6 and 12 Months
Hide Description 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).
Time Frame 0, 6 and 12 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Change in Caregiver Quality of Life at 6 and 12 Months
Hide Description 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.
Time Frame 0, 6 and 12 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change in Care Recipient Quality of Life at 6 and 12 Months
Hide Description 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.
Time Frame 0, 6 and 12 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change in Process Measures of Dementia Care Quality at 6 and 12 Months
Hide Description 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.
Time Frame 0, 6 and 12 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dementia Care Management in Person Dementia Care Management Telephone Only
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Dementia Care Management in Person Dementia Care Management Telephone Only
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dementia Care Management in Person Dementia Care Management Telephone Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)   0/73 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dementia Care Management in Person Dementia Care Management Telephone Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/71 (0.00%)   0/73 (0.00%) 
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
Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT01459783     History of Changes
Other Study ID Numbers: HQ217RC4
1RC4AG038804-01 ( U.S. NIH Grant/Contract )
First Submitted: January 18, 2011
First Posted: October 26, 2011
Results First Submitted: February 25, 2015
Results First Posted: May 22, 2015
Last Update Posted: May 22, 2015