Background:
Given the current lack of disease-modifying therapies, it is important to explore new modelsof longitudinal care for older adults with dementia that focus on improving quality of life anddelaying functional decline. In a previous clinical trial, we demonstrated that collaborativecare for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well ascaregiver stress. However, these improvements in quality of life were not associated withdelays in subjects’ functional decline.Trial designParallel randomized controlled clinical trial with 1:1 allocation.ParticipantsA total of 180 community-dwelling patients aged [greater than or equal to]45 years who are diagnosed with possibleor probable Alzheimer’s disease; subjects must also have a caregiver willing to participate inthe study and be willing to accept home visits. Subjects and their caregivers are enrolled fromthe primary care and geriatric medicine practices of an urban public health system servingIndianapolis, Indiana, USA.InterventionsAll patients receive best practices primary care including collaborative care by a dementiacare manager over two years; this best practices primary care program represents the localadaptation and implementation of our prior collaborative care intervention in the urban publichealth system. Intervention patients also receive in-home occupational therapy delivered intwenty-four sessions over two years in addition to best practices primary care. The focus ofthe occupational therapy intervention is delaying functional decline and helping both subjectsand caregivers adapt to functional impairments. The in-home sessions are tailored to thespecific needs and goals of each patient-caregiver dyad; these needs are expected to changeover the course of the study.ObjectiveTo determine whether best practices primary care plus home-based occupational therapydelays functional decline among patients with Alzheimer’s disease compared to subjectstreated in the control group.OutcomesThe primary outcome is the Alzheimer’s Disease Cooperative Studies Group Activities ofDaily Living Scale; secondary outcome measures are two performance-based measuresincluding the Short Physical Performance Battery and Short Portable Sarcopenia Measure.Outcome assessments for both the caregiver-reported scale and subjects’ physicalperformance scales are completed in the subject’s home.RandomizationEligible patient-care giver dyads will be stratified by clinic type and block randomized with acomputer developed randomization scheme using a 1:1 allocation ratio.BlindingSingle blinded. Research assistants completing the outcome assessments were blinded to thesubjects’ treatment group.Trial statusOngoingClinicalTrial.Gov identifierNCT01314950; date of completed registration 10 March 2011; date first patient randomized 9March 2011