Skip to main content
OpenTrials
Completed

NCT Number: NCT01459783

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Olive View-UCLA Medical Center

Sylmar, California, 91342-1495, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Caregiver Burden at 6 and 12 Months

    Time frame: 0, 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.

  2. Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months

    Time frame: 0, 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.

Secondary outcomes

  1. Change in Caregiver Depression at 6 and 12 Months

    Time frame: 0, 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).

  2. Change in Caregiver Quality of Life at 6 and 12 Months

    Time frame: 0, 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.

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

    Time frame: 0, 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.

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

    Time frame: 0, 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.

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

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

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 26, 2011
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.