Comparative Effectiveness of Dementia Care Strategies in Underserved Communities

Brief Summary

Official Title: “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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
  • Study Primary Completion Date: October 2013

Interventions Used in this Clinical Trial

  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • 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.
  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in caregiver burden at 6 and 12 months
    • Time Frame: 0, 6 and 12 months
      Safety Issue?: No
  • Change in care recipient memory and problem behaviors at 6 and 12 months
    • Time Frame: 0, 6 and 12 months
      Safety Issue?: No

Secondary Measures

  • Change in caregiver depression at 6 and 12 months
    • Time Frame: 0, 6 and 12 months
      Safety Issue?: No
  • Change in caregiver quality of life at 6 and 12 months
    • Time Frame: 0, 6 and 12 months
      Safety Issue?: No
  • Change in care recipient quality of life at 6 and 12 months
    • Time Frame: 0, 6 and 12 months
      Safety Issue?: No
  • Change in process measures of dementia care quality at 6 and 12 months
    • Time Frame: 0, 6 and 12 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • RAND
  • Collaborator
    • Olive View-UCLA Education & Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joshua Chodosh, M.D., MSHS, Principal Investigator, RAND
    • Barbara Vickrey, M.D., MPH, Principal Investigator, RAND

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01459783