Comparative Effectiveness of Dementia Care Strategies in Underserved Communities

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01459783

Enrollment

144

Registered

2011-10-26

Start date

2011-03-31

Completion date

2013-10-31

Last updated

2015-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

Caregivers, Comparative Effectiveness Research, Cost Effectiveness, Patient Care Management, Social Work

Brief 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. 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.

Interventions

BEHAVIORALDementia 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. An electronic tracking tool and resource manual guide delivery of the care management protocols.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Caregiver Burden at 6 and 12 Months	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	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.

Secondary

Measure	Time frame	Description
Change in Caregiver Depression at 6 and 12 Months	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).
Change in Caregiver Quality of Life at 6 and 12 Months	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.
Change in Care Recipient Quality of Life at 6 and 12 Months	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.
Change in Process Measures of Dementia Care Quality at 6 and 12 Months	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.

Countries

United States

Participant flow

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.

Participants by arm

Arm	Count
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.	71
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.	73
Total	144

Withdrawals & dropouts

Period	Reason	FG000	FG001
6 Months to 12 Months	Death	0	1
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
6 Months to 12 Months	Withdrawal by Subject	6	5
Baseline to 6 Months	Death	1	0
Baseline to 6 Months	Lost to Follow-up	19	14
Baseline to 6 Months	Withdrawal by Subject	12	6

Baseline characteristics

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

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 71	0 / 73
serious Total, serious adverse events	0 / 71	0 / 73

Outcome results

Primary

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.