Comparative Effectiveness of Dementia Care Strategies in Underserved Communities

Dementia Clinical Trial

Official title:

Comparative Effectiveness of Dementia Care Strategies in Underserved Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459783
• Other study ID #: HQ217RC4
• Secondary ID: 1RC4AG038804-01
• Status: Completed
• Phase: N/A
• First received: January 18, 2011
• Last updated: May 6, 2015
• Start date: March 2011
• Est. completion date: October 2013

Study information

• Verified date: May 2015
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• 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. An electronic tracking tool and resource manual guide delivery of the care management protocols.

Locations

Country	Name	City	State
United States	Olive View-UCLA Medical Center	Sylmar	California

Sponsors (4)

Lead Sponsor	Collaborator
RAND	Alzheimer's Association, National Institute on Aging (NIA), Olive View-UCLA Education & Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Heal — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	0, 6 and 12 months	No
Primary	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.	0, 6 and 12 months	No
Secondary	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).	0, 6 and 12 months	No
Secondary	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.	0, 6 and 12 months	No
Secondary	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.	0, 6 and 12 months	No
Secondary	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.	0, 6 and 12 months	No