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PACT: Providers and Alzheimer's Caregivers Together

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00182897
First received: September 12, 2005
Last updated: November 9, 2006
Last verified: November 2006
  Purpose

The primary goal of the study is documentation of effectiveness of a home-based intervention to reduce caregiver burden related to dementia caregiving, improve caregiver health status, and reduce caregiver and care recipient resource utilization.


Condition Intervention
Alzheimer's Disease
Dementia
Behavioral: Skills Building for Caregiver Health and Care-recipient

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Providers and Alzheimer's Caregivers Together

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • General well-being, measured with the revised Rand General Well-Being Scale
  • caregiver’s level of distress with care recipient behaviors, measured with the Revised Memory and Behavior Problems Checklist at Baseline, within 2 weeks of home care ending and six months.

Secondary Outcome Measures:
  • Determine the cost-effectiveness of home-based intervention; data will be collected at Baseline, within 2 weeks of home care ending and six months.

Estimated Enrollment: 120
Study Start Date: October 2000
Estimated Study Completion Date: November 2005
Detailed Description:

This study focuses on an underserved, understudied population: African American and White homebound persons with dementia and their caregivers (CGs). Severe dementia, frailty, multiple disabling co-morbid diseases, lack of transportation, inability to afford or obtain a sitter for the care recipient (CR), and lack of time in a CG's burdened daily schedule may prevent care dyads (caregivers and their family member with dementia) from receiving services in primary care settings and from participating in clinical studies. Homebound issues may be particularly important for African American CGs, yet the minority CG literature has not addressed relevant issues for homebound dyads. Nor are the chronic needs of homebound dementia care dyads adequately attended by the current home health care system, which now focuses on skilled nursing care. This study has been designed to address these research deficits. The study will examine the benefit (through improving depression, anxiety, and health perception) and the cost-effectiveness of home-based dementia caregiving interventions, with attention to both the informal care provided by the CG and the use of formal care services.

Care dyads will be randomized to either Usual Care or Enhanced Care. Both Usual Care and Enhanced Care caregivers will receive usual home health care delivered by home health nurses on the schedule determined by the patient's needs and set by the home care agency. For the Enhanced Care caregivers, to ensure protocol adherence, using the same schedule as the home health visits, trained interventionists from the research staff will deliver the intervention. The interventionists will teach dementia family caregivers to cope with difficult care recipient behaviors and challenges to caregiving and will teach caregivers how to cope with their own responses to caregiving. Following established protocols and using fifth grade level pamphlets and educational material, the interventionists will tailor the intervention sessions to meet the individual needs of each care dyad in their own home environment. Enhanced Care sessions will not exceed 60 minutes. Research specialists will perform data collection visits in the care dyads’ homes at baseline, within 2 weeks of home care ending and six months.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Care Recipient - Inclusion Criteria (must have all)

  • Documented diagnosis of dementia or Mini-Mental State Exam score <23
  • Functional impairment: presence of two IADL (Instrumental Activities of Daily Living) impairment (transportation, shopping) or one Activities of Daily Living (ADL) impairment (bathing, toileting)

Caregiver - Inclusion Criteria (must have all)

  • At least 21 years old
  • A family member of the care recipient
  • Must have a telephone
  • Must plan to remain in the area for the duration of the intervention and follow-up
  • Must have been a caregiver for more than 6 months
  • Must provide at least 4 hours of supervision or direct assistance per day for the care recipient

Exclusion Criteria:

Care Recipient

  • Any terminal illness with life expectancy of less than 6 months
  • Active treatment (chemotherapy or radiation therapy) for cancer
  • More than three acute medical hospitalizations in the past year (other than psychiatric or Alzheimer’s Disease related admissions)
  • Schizophrenia
  • Dementia secondary to head trauma
  • Blindness or deafness if either disability prohibits them from data collection or participation in the interventions

Caregiver

  • Any terminal illness with life expectancy of less than 6 months
  • Active treatment (chemotherapy or radiation therapy) for cancer
  • More than three acute medical hospitalizations in the past year
  • Imminent placement of care recipient into a nursing home (within 6 months)
  • Involvement in another clinical trial for caregivers, including REACH
  • Miscellaneous barriers such as transportation, commitment, hesitancy, etc.
  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: NCT00182897

Locations
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
Investigators
Principal Investigator: Linda Nichols, PhD Program Director, Interprofessional Team Training & Development, Veterans Affairs Medical Center; Associate Professor, Preventive Medicine and Medicine, University of Tennessee Health Science Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00182897     History of Changes
Other Study ID Numbers: IA0081, 5R01AG016328
Study First Received: September 12, 2005
Last Updated: November 9, 2006
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
caregiver
home health care
coping

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

ClinicalTrials.gov processed this record on November 20, 2014