Alzheimer's disease multiple intervention trial (ADMIT): Study protocol for a randomized controlled clinical trial

Christopher Callahan, Malaz Boustani, Arlene A. Schmid, Mary Austrom, Douglas K. Miller, Sujuan Gao, Carrie S. Morris, Mickey Vogel, Hugh Hendrie

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background: Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer's disease reduces patients' neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects' functional decline.Trial design: Parallel randomized controlled clinical trial with 1:1 allocation.Participants: A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer's disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA.Interventions: All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study.Objective: To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer's disease compared to subjects treated in the control group.Outcomes: The primary outcome is the Alzheimer's Disease Cooperative Studies Group Activities of Daily Living Scale; secondary outcome measures are two performance-based measures including the Short Physical Performance Battery and Short Portable Sarcopenia Measure. Outcome assessments for both the caregiver-reported scale and subjects' physical performance scales are completed in the subject's home.Randomization: Eligible patient-care giver dyads will be stratified by clinic type and block randomized with a computer developed randomization scheme using a 1:1 allocation ratio.Blinding: Single blinded. Research assistants completing the outcome assessments were blinded to the subjects' treatment group.Trial status: Ongoing. ClinicalTrial.Gov identifier: NCT01314950; date of completed registration 10 March 2011; date first patient randomized 9 March 2011.

Original languageEnglish
Article number92
JournalTrials
Volume13
DOIs
StatePublished - Jun 27 2012

Fingerprint

Clinical Protocols
Caregivers
Alzheimer Disease
Randomized Controlled Trials
Primary Health Care
Practice Guidelines
Occupational Therapy
Urban Health
Outcome Assessment (Health Care)
Random Allocation
Dementia
Quality of Life
Sarcopenia
Independent Living
House Calls
Activities of Daily Living
Geriatrics
Patient Care
Public Health
Medicine

Keywords

  • Alzheimer's disease
  • behavioral interventions
  • functional decline
  • primary care

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Alzheimer's disease multiple intervention trial (ADMIT) : Study protocol for a randomized controlled clinical trial. / Callahan, Christopher; Boustani, Malaz; Schmid, Arlene A.; Austrom, Mary; Miller, Douglas K.; Gao, Sujuan; Morris, Carrie S.; Vogel, Mickey; Hendrie, Hugh.

In: Trials, Vol. 13, 92, 27.06.2012.

Research output: Contribution to journalArticle

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