Patients with dementia and family caregivers were recruited from March 2006 to June 2008 through media announcements and mailings by social agencies targeting caregivers. Study procedures were explained to interested caregivers contacting the research team (telephone, return postcard), and a brief telephone eligibility screen was administered. Eligible patients had a physician diagnosis of probable dementia (using criteria from NINCDS/ADRDA [National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association]) or a Mini-Mental State Examination (MMSE)15 (link) score less than 24; they also were 21 years or older and English speaking, needed help with daily activities or had behavioral symptoms, and lived with or within 5 miles of family caregivers. Eligible caregivers provided oversight or care for 8 or more hours weekly, planned to live in the area for 9 months, were not seeking nursing home placement, and reported difficulty managing patient functional decline or behaviors.
Exclusion criteria for dyads were terminal illnesses with life expectancy of less than 9 months, active treatments for cancer, more than 3 acute hospitalizations in the past year, or involvement in another caregiver trial. Patients were excluded if they had schizophrenia or bipolar disorder, had dementia secondary to probable head trauma, or had an MMSE score of 0 and were bed-bound.
Written informed consent was obtained from caregivers prior to baseline interviews using forms approved by the institutional review board. Caregivers provided proxy patient consent and patient assent was obtained for each patient-related assessment using scripts approved by the institutional review board. Families were compensated $20 at each interview for their participation.
Following baseline interviews, dyads were randomized to the COPE or control group and reassessed by telephone at 4 and 9 months by interviewers masked to participant group. Consistent with other trials,13 (link),16 caregivers of patients placed in nursing homes prior to 4 months (n=7) were reassessed at 4 months (but not 9 months) in areas amenable to reporting. Caregivers of patients who died (n=21) were not reassessed at 4 months (n=9) or 9 months (n=12) nor included in analyses, as outcome measures were not relevant.
Exclusion criteria for dyads were terminal illnesses with life expectancy of less than 9 months, active treatments for cancer, more than 3 acute hospitalizations in the past year, or involvement in another caregiver trial. Patients were excluded if they had schizophrenia or bipolar disorder, had dementia secondary to probable head trauma, or had an MMSE score of 0 and were bed-bound.
Written informed consent was obtained from caregivers prior to baseline interviews using forms approved by the institutional review board. Caregivers provided proxy patient consent and patient assent was obtained for each patient-related assessment using scripts approved by the institutional review board. Families were compensated $20 at each interview for their participation.
Following baseline interviews, dyads were randomized to the COPE or control group and reassessed by telephone at 4 and 9 months by interviewers masked to participant group. Consistent with other trials,13 (link),16 caregivers of patients placed in nursing homes prior to 4 months (n=7) were reassessed at 4 months (but not 9 months) in areas amenable to reporting. Caregivers of patients who died (n=21) were not reassessed at 4 months (n=9) or 9 months (n=12) nor included in analyses, as outcome measures were not relevant.
