Comparative Effectiveness of Dementia Care Strategies in Underserved Communities

This study has been completed.
Sponsor:
Collaborators:
Olive View-UCLA Education & Research Institute
Alzheimer's Association
Information provided by (Responsible Party):
RAND
ClinicalTrials.gov Identifier:
NCT01459783
First received: January 18, 2011
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Dementia
Behavioral: Dementia care management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Comparative Effectiveness of Dementia Care Strategies in Underserved Communities

Resource links provided by NLM:


Further study details as provided by RAND:

Primary Outcome Measures:
  • Change in caregiver burden at 6 and 12 months [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
    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.

  • Change in care recipient memory and problem behaviors at 6 and 12 months [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
    The Revised Memory and Behavior Problem Checklist (RMBPC) was developed by Teri and colleagues. The behavior portion of the RMBPC instrument rates three domains of care receiver problems (behavior, memory, and depression) and caregiver's reaction to each of these problems. The 3 domain subscales and the summary score each have a corresponding subscale for caregiver reaction to these 3 problem types.


Secondary Outcome Measures:
  • Change in caregiver depression at 6 and 12 months [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 144
Study Start Date: March 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Active Comparator: 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.
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459783

Locations
United States, California
Olive View-UCLA Medical Center
Sylmar, California, United States, 91342-1495
Sponsors and Collaborators
RAND
Olive View-UCLA Education & Research Institute
Alzheimer's Association
Investigators
Principal Investigator: Joshua Chodosh, M.D., MSHS RAND
Principal Investigator: Barbara Vickrey, M.D., MPH RAND
  More Information

No publications provided

Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT01459783     History of Changes
Other Study ID Numbers: HQ217RC4, 1RC4AG038804-01
Study First Received: January 18, 2011
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by RAND:
Caregivers
Comparative Effectiveness Research
Cost Effectiveness
Patient Care Management
Social Work

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014