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Gitlin LN, Winter L, Dennis MP, Hodgson N, Hauck WW. A Biobehavioral Home-Based Intervention and the Well-being of Patients With Dementia and Their Caregivers: The COPE Randomized Trial. JAMA. 2010;304(9):983–991. doi:10.1001/jama.2010.1253
Author Affiliations: Jefferson Center for Applied Research on Aging and Health, Thomas Jefferson University, Philadelphia, Pennsylvania (Drs Gitlin, Winter, Dennis, and Hodgson); Sycamore Consulting, New Hope, Pennsylvania (Dr Hauck).
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 well-being (adjusted mean difference in Perceived Change Index, 0.22; 95% CI, 0.08-0.36; 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 (χ21 = 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
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