Trial Outcomes & Findings for Comparative Effectiveness of Dementia Care Strategies in Underserved Communities (NCT NCT01459783)

Last Updated: 2015-05-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

144 participants

Primary outcome timeframe

0, 6 and 12 months

Results posted on

2015-05-22

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	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.
Baseline to 6 Months STARTED	71	73
Baseline to 6 Months COMPLETED	39	53
Baseline to 6 Months NOT COMPLETED	32	20
6 Months to 12 Months STARTED	39	53
6 Months to 12 Months COMPLETED	20	23
6 Months to 12 Months NOT COMPLETED	19	30

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Baseline to 6 Months Death	1	0
Baseline to 6 Months Withdrawal by Subject	12	6
Baseline to 6 Months Lost to Follow-up	19	14
6 Months to 12 Months Death	0	1
6 Months to 12 Months Withdrawal by Subject	6	5
6 Months to 12 Months Lost to Follow-up	2	7
6 Months to 12 Months Study ended before 12-month follow-up	11	17

Baseline Characteristics

Comparative Effectiveness of Dementia Care Strategies in Underserved Communities

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dementia Care Management in Person n=71 Participants 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 n=73 Participants 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 n=144 Participants Total of all reporting groups
Age, Continuous	48.07 years STANDARD_DEVIATION 14.28 • n=5 Participants	50.95 years STANDARD_DEVIATION 12.71 • n=7 Participants	49.53 years STANDARD_DEVIATION 13.53 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	46 Participants n=7 Participants	94 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	27 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized African American	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants
Race/Ethnicity, Customized Caucasian or Euro-American	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	52 participants n=5 Participants	60 participants n=7 Participants	112 participants n=5 Participants
Race/Ethnicity, Customized Other	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants
Education Less than high school	25 participants n=5 Participants	27 participants n=7 Participants	52 participants n=5 Participants
Education High school graduate or GED	19 participants n=5 Participants	13 participants n=7 Participants	32 participants n=5 Participants
Education Some college or 2-year degree	12 participants n=5 Participants	22 participants n=7 Participants	34 participants n=5 Participants
Education 4-year college or more	15 participants n=5 Participants	11 participants n=7 Participants	26 participants n=5 Participants
Language spoken with friends and family English	25 participants n=5 Participants	24 participants n=7 Participants	49 participants n=5 Participants
Language spoken with friends and family Spanish	39 participants n=5 Participants	46 participants n=7 Participants	85 participants n=5 Participants
Language spoken with friends and family Other	7 participants n=5 Participants	3 participants n=7 Participants	10 participants n=5 Participants
Relationship type to care recipient Spouse	9 participants n=5 Participants	16 participants n=7 Participants	25 participants n=5 Participants
Relationship type to care recipient Son/Daughter	36 participants n=5 Participants	41 participants n=7 Participants	77 participants n=5 Participants
Relationship type to care recipient Brother/sister	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Relationship type to care recipient Cousin/other relative	6 participants n=5 Participants	1 participants n=7 Participants	7 participants n=5 Participants
Relationship type to care recipient Other	19 participants n=5 Participants	14 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 0, 6 and 12 months

Outcome measures

Outcome measures
Measure	Dementia Care Management in Person n=71 Participants 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 n=73 Participants 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.
Change in Caregiver Burden at 6 and 12 Months Unadjusted score at 6 months	29.99 units on a scale Standard Deviation 17.51	30.09 units on a scale Standard Deviation 19.6
Change in Caregiver Burden at 6 and 12 Months Unadjusted score at 12 months	28.1 units on a scale Standard Deviation 18.53	28.13 units on a scale Standard Deviation 11.84
Change in Caregiver Burden at 6 and 12 Months Baseline score	30.07 units on a scale Standard Deviation 16.99	30.91 units on a scale Standard Deviation 17.98

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Dementia Care Management in Person n=71 Participants 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 n=73 Participants 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.
Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months unadjusted 6 month post intervention	9.68 units on a scale Standard Deviation 5.53	8.53 units on a scale Standard Deviation 5.33
Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months 12 month unadjusted post-intervention	8.2 units on a scale Standard Deviation 5.86	9.26 units on a scale Standard Deviation 5.26
Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months Baseline score	9.44 units on a scale Standard Deviation 4.92	9.43 units on a scale Standard Deviation 5.27

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 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.

Outcome measures

Outcome data not reported

Adverse Events

Dementia Care Management in Person

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dementia Care Management Telephone Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joshua Chodosh or Barbara Vickrey

University of California Los Angeles

Phone: 310-206-7671

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place