Comparative Effectiveness of Dementia Care Strategies in Underserved Communities

This study is enrolling participants by invitation only.
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: January 29, 2013
Last verified: January 2013

January 18, 2011
January 29, 2013
March 2011
August 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01459783 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Comparative Effectiveness of Dementia Care Strategies in Underserved Communities
Comparative Effectiveness of Dementia Care Strategies in Underserved Communities

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Dementia
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 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.
    Intervention: Behavioral: Dementia care management
  • 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.
    Intervention: Behavioral: Dementia care management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
250
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01459783
HQ217RC4, 1RC4AG038804-01
Yes
RAND
RAND
  • Olive View-UCLA Education & Research Institute
  • Alzheimer's Association
  • National Institute on Aging (NIA)
Principal Investigator: Joshua Chodosh, M.D., MSHS RAND
Principal Investigator: Barbara Vickrey, M.D., MPH RAND
RAND
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP