A biobehavioral home-based intervention and the well-being of patients with dementia and their caregivers: the COPE randomized trial.
BACKGROUND
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.


METHODS
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.


METHODS
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.


METHODS
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 (chi(2/1) = 6.72, P = . 01).


CONCLUSIONS
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.


BACKGROUND
clinicaltrials.gov Identifier: NCT00259454.
Gitlin
Laura N
LN
Jefferson Center for Applied Research on Aging and Health, Thomas Jefferson University, 130 S Ninth St, Ste 513, Philadelphia, PA 19130, USA. laura.gitlin@jefferson.edu
Winter
Laraine
L
Dennis
Marie P
MP
Hodgson
Nancy
N
Hauck
Walter W
WW
D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D001521:Behavior Therapy; D017028:Caregivers; D003704:Dementia / Q000150:complications / Q000451:nursing / Q000503:physiopathology* / Q000628:therapy*; D005260:Female; D006304:Health Status; D006699:Home Care Services; D006801:Humans; D007398:Interpersonal Relations; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome
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