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Comparative effectiveness of behavioral interventions to prevent or delay dementia
Investigator (PI): Smith, Glenn E
Performing Organization (PO): (Current): University of Florida, College of Public Health and Health Professions, Department of Clinical and Health Psychology / (352) 273-6617
(Past): Mayo Clinic, Department of Psychiatry and Psychology / (507) 284-2511
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2015
Final Year: 2020
Record Source/Award ID: PCORI/CER-1306-01897-IC
Funding: Total Award Amount: $2,072,271
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: People with a formal diagnosis of mild cognitive impairment (MCI) are at risk of progressing to dementia, typically Alzheimer disease. However, research increasingly shows that behavioral intervention can limit functional decline and maintain quality of life, key outcomes of importance to these patients and their families. Families want to engage behavioral interventions to maintain their highest level of function but are not sure what works best for which outcomes. We currently provide a 10-day, 50-hour program representing an intensive state-of-the-art behavioral approach to preventing progression in MCI. It is offered 12 times per year across Mayo Clinic sites in Minnesota, Florida, and Arizona. Nearly 150 patients per year are already completing this program. The five daily components are one hour each of 1) daily physical exercise, 2) computer-based cognitive exercise, 3) patient and family education, 4) separate support groups for MCI patients and their care partners, and 5) memory support system compensation training developed in a previous NIH study. There is research providing some supporting evidence for each of these separate interventions but little comparing each component to the others. Thus, we cannot say for sure which components deliver the highest value for patients and their families, nor if any are unnecessary given the presence of the other components. In the proposed study we will (1) engage past consumers/patients and their care partners in the prioritization of outcomes for persons diagnosed with MCI, and in the evaluation of likely contributions of different behavioral interventions to those outcomes; (2) incorporate the results of #1 into a study comparing the effectiveness of each of the five components of the program to the other components; and (3) demonstrate the use of a novel research design and data analysis method for the evaluation of multicomponent interventions that allows all participants to receive 80% of the intervention. In the first quarter year we will survey past program participants to finalize outcome priorities and design issues. Once the trial launches, we will use all three Mayo sites to enroll 364 people with MCI and their program partners in the study. We propose a novel method of offering the program while randomly suppressing one of the components per session to evaluate what is lost by the absence of any given component. Over the 25 sessions there will be more than 70 couples randomized to each condition. The outcomes we will study involve daily function and cognition in the MCI patient; quality of life, mood, and self-efficacy in MCI patient and caregiver; and caregiver burden. These measures are completed at baseline, end of treatment, and at 3- and 6-month follow-up. The methods we use to assure that the interventions are delivered in the same way at all sites will also permit us to share these interventions with other providers after the study is complete.
MeSH Terms:
  • Arizona
  • Behavior Therapy /methods
  • Caregivers
  • Clinical Trials as Topic
  • Cognition Disorders /*therapy
  • Comparative Effectiveness Research
  • Dementia /*prevention & control
  • /*therapy
  • * Exercise
  • Florida
  • Humans
  • Memory
  • Minnesota
  • National Institutes of Health (U.S.)
  • Outcome Assessment, Health Care
  • Quality of Life
Country: United States || United States
State: Florida || Minnesota
Zip Code: 32611 / 55905
UI: 20143540
CTgovId: NCT02265757
Project Status: Completed
Record History: ('2019: Project extended to 2019. 2017: Project extended to 2018 and changed PO and PI email address.',) ('Project initial year changed from 2014 to 2015 per PCORI (institutional change), and project extended to 2020, 2/17/2020',)