FACTS / NCT01194128

Study ID(s) and Acronym(s)
NCT01194128 // R01 NR009573 // FACTS
Current Status of Trial
Ongoing
Study Aim
Caregiver Focused
Study Design
RCT
Blinding
Double-blind
Intervention type
Non-pharmacological
Intervention
Psychoeducational Support//Information Only control
Dosage and Duration
The experiemntal group: Psychoeducational Support: comprised of 3 modules - one on the clinical aspects of frailty, one on advanced care planning, and one aimd at improving the emotional well-being of family caregivers. The intervention will be delivered via 11 sessions lasting 90mins each distributed over a six month period. All family caregivers will begin with the Basic Knowledge Module. Modules Two and Three will be delivered in alternating sessions, based on caregiver need and preference, a strategy successfully used in the REACH intervention trial//Information only control group: will receive a portion of the standardized packet of written information that is also provided to the treatment group. This packet will contain several fact sheets from a nationally-recognized expert source in caregiving (the Family Caregiver Alliance's National Center on Caregiving) and a national information and advocacy group (the National Citizens' Coalition for Nursing Home Reform). The fact sheets are relevant to the placement of a family member into a nursing home and are linked to the content areas covered in the intervention
Absolute Number of Participants
216
Health Status/Diagnosis
Caregiver
Main Diagnostic Criteria
Family member of institutionalized person; Provided a minimum of 3 months of in-home care prior to institutionalization
Country or Countries of Recruitment
United States (USA)
Unit of Allocation and/or Setting
Care home residents
Study start date
January 2008
Study completion date
Estimated primary completion date: March 2012
Primary outcomes
Primary Outcome Measures: Depression; State Anxiety; Caregiver Burdene; Complicated Grief//Secondary Ourcome Measures: Prescription Medication Use; Social Activities; Quality of life AD (of the AD patient); Texas Revised Inventory of Grief; After-death bereaved family member interview; Overall rating scale for patient focussed, family centered care
Key Points
The care recipient must be 50 years or older and have been permanently placed within a long-term care facility within the last 120 days with impairment in at least 3 of 6 Activities of Daily Living