A Biobehavioral Home-Based Intervention and the Well-being of Patients With Dementia and Their Caregivers The COPE Randomized Trial

Context Optimal treatment to postpone functional decline in patients with dementia is not established. Objective To test a nonpharmacologic intervention realigning environmental demands with patient capabilities. Design, Setting, and Participants Prospective 2-group randomized trial (Care of Persons with Dementia in their Environments [COPE]) involving patients with dementia and family caregivers (community-living dyads) recruited from March 2006 through June 2008 in Pennsylvania. Interventions Up to 12 home or telephone contacts over 4 months by health professionals who assessed patient capabilities and deficits; obtained blood and urine samples; and trained families in home safety, simplifying tasks, and stress reduction. Control group caregivers received 3 telephone calls and educational materials. Main Outcome Measures Functional dependence, quality of life, frequency of agitated behaviors, and engagement for patients and well-being, confidence using activities, and perceived benefits for caregivers at 4 months. Results Of 284 dyads screened, 270 (95%) were eligible and 237 (88%) randomized. Data were collected from 209 dyads (88%) at 4 months and 173 (73%) at 9 months. At 4 months, compared with controls, COPE patients had less functional dependence (adjusted mean difference, 0.24; 95% CI, 0.03-0.44; P=.02; Cohen d=0.21) and less dependence in instrumental activities of daily living (adjusted mean difference, 0.32; 95% CI, 0.09-0.55; P=.007; Cohen d=0.43), measured by a 15-item scale modeled after the Functional Independence Measure; COPE patients also had improved engagement (adjusted mean difference, 0.12; 95% CI, 0.07-0.22; P=.03; Cohen d=0.26), measured by a 5-item scale. COPE caregivers improved in their wellbeing (adjusted mean difference in Perceived Change Index, 0.22; 95% CI, 0.080.36; P=.002; Cohen d=0.30) and confidence using activities (adjusted mean difference, 0.81; 95% CI, 0.30-1.32; P=.002; Cohen d=0.54), measured by a 5-item scale. By 4 months, 64 COPE dyads (62.7%) vs 48 control group dyads (44.9%) eliminated 1 or more caregiver-identified problems (chi(2)(1)=6.72, P=.01). Conclusion Among community-living dyads, a nonpharmacologic biobehavioral environmental intervention compared with control resulted in better outcomes for COPE dyads at 4 months. Although no group differences were observed at 9 months for patients, COPE caregivers perceived greater benefits. Trial Registration clinicaltrials.gov Identifier: NCT00259454 JAMA. 2010; 304(9): 983-991 www.jama.com