Comparative Effectiveness of Dementia Care Strategies in Underserved Communities

NCT01459783 | Completed Results DMC

• 2 other identifiers: HQ217RC41RC4AG038804-01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (4)

• Change in Caregiver Depression at 6 and 12 Months

  0, 6 and 12 months

• Change in Caregiver Quality of Life at 6 and 12 Months

  0, 6 and 12 months

• Change in Care Recipient Quality of Life at 6 and 12 Months

  0, 6 and 12 months

• Change in Process Measures of Dementia Care Quality at 6 and 12 Months

  0, 6 and 12 months

Study Arms (2)

Dementia care management in person

ACTIVE COMPARATOR

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.

Behavioral: Dementia care management

Dementia care management telephone only

ACTIVE COMPARATOR

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.

Behavioral: Dementia care management

Interventions

Dementia care management BEHAVIORAL

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.

Dementia care management in person; Dementia care management telephone only

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RAND: lead
• Olive View-UCLA Education & Research Institute: collaborator
• Alzheimer's Association: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Olive View-UCLA Medical Center

Sylmar, California, 91342-1495, United States

Location

Related 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 Health. 2015 Aug;27(5):864-93. doi: 10.1177/0898264315569454. Epub 2015 Feb 4.

  PMID: 25656074 RESULT

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Joshua Chodosh or Barbara Vickrey
• Organization: University of California Los Angeles

jchodosh@mednet.ucla.edu

310-206-7671

Study Officials

• Joshua Chodosh, M.D., MSHS

  RAND

  PRINCIPAL INVESTIGATOR

• Barbara Vickrey, M.D., MPH

  RAND

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: October 26, 2011
• Study Start: March 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 22, 2015
• Results First Posted: May 22, 2015

Record last verified: 2015-05

Locations

US (1)