This research project is in progress. PCORI will post its findings here within 90 days after our final review is complete. In the meantime, results have been published in peer-reviewed journals, as listed below.
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 1 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:
- 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
- Incorporate the results of #1 into a study comparing the effectiveness of each of the five components of the program to the other components
- 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 followup. 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.
Results of This Project
^Glenn E. Smith was affiliated with the Mayo Clinic when this project was funded.