Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2000-10-31
2005-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Skills Building for Caregiver Health and Care-recipient
Eligibility Criteria
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Inclusion Criteria
* Functional impairment: presence of two IADL (Instrumental Activities of Daily Living) impairment (transportation, shopping) or one Activities of Daily Living (ADL) impairment (bathing, toileting)
* 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
* 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.
21 Years
ALL
Yes
Sponsors
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National Institute of Nursing Research (NINR)
NIH
National Institute on Aging (NIA)
NIH
Principal Investigators
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Linda Nichols, PhD
Role: PRINCIPAL_INVESTIGATOR
Program Director, Interprofessional Team Training & Development, Veterans Affairs Medical Center; Associate Professor, Preventive Medicine and Medicine, University of Tennessee Health Science Center
Locations
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University of Tennessee Health Science Center
Memphis, Tennessee, United States
Countries
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References
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Burns R, Nichols LO, Martindale-Adams J, Graney MJ, Lummus A. Primary care interventions for dementia caregivers: 2-year outcomes from the REACH study. Gerontologist. 2003 Aug;43(4):547-55. doi: 10.1093/geront/43.4.547.
Connell CM, Gibson GD. Racial, ethnic, and cultural differences in dementia caregiving: review and analysis. Gerontologist. 1997 Jun;37(3):355-64. doi: 10.1093/geront/37.3.355.
Haley WE, Roth DL, Coleton MI, Ford GR, West CA, Collins RP, Isobe TL. Appraisal, coping, and social support as mediators of well-being in black and white family caregivers of patients with Alzheimer's disease. J Consult Clin Psychol. 1996 Feb;64(1):121-9. doi: 10.1037//0022-006x.64.1.121.
Hall GR, Buckwalter KC, Stolley JM, Gerdner LA, Garand L, Ridgeway S, Crump S. Standardized care plan. Managing Alzheimer's patients at home. J Gerontol Nurs. 1995 Jan;21(1):37-47. doi: 10.3928/0098-9134-19950101-08.
Other Identifiers
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IA0081
Identifier Type: -
Identifier Source: org_study_id