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. 2017 Nov 27;6(11):e223.
doi: 10.2196/resprot.8103.

Behavioral Interventions to Prevent or Delay Dementia: Protocol for a Randomized Comparative Effectiveness Study

Glenn Smith  1 , Melanie Chandler  2 , Dona Ec Locke  3 , Julie Fields  4 , Vaishali Phatak  5 , Julia Crook  6 , Sherrie Hanna  4 , Angela Lunde  4 , Miranda Morris  2 , Michelle Graff-Radford  2 , Christine A Hughes  4 , Susan Lepore  4 , Andrea Cuc  3 , Maria Caselli  3 , Duane Hurst  3 , Jennifer Wethe  3 , Andrea Francone  3 , Jeanne Eilertsen  3 , Pauline Lucas  3 , Charlene Hoffman Snyder  3 , LeeAnn Kuang  3 , Marigrace Becker  7 , Pamela Dean  8 , Nancy Diehl  6 , Marvin Lofquist  9 , Shirley Vanderhook  9 , Diana Myles  10 , Denise Cochran  9
Affiliations

Behavioral Interventions to Prevent or Delay Dementia: Protocol for a Randomized Comparative Effectiveness Study

Glenn Smith et al. JMIR Res Protoc. .

Abstract

Background: Currently, people at risk for dementia and their caregivers are confronted with confusing choices about what behavioral interventions are most effective.

Objective: The objective of this study is to determine which empirically supported behavioral interventions most impact the outcomes highly valued by patients with mild cognitive impairment and their partners.

Methods: This protocol describes a comparative effectiveness trial targeting 300 participants with mild cognitive impairment and their study partners. The trial is being conducted at the Mayo Clinic campuses in Arizona, Florida, Minnesota, and the University of Washington in Seattle. The study examines the contribution of five behavioral interventions (yoga, memory compensation training, computerized cognitive training, support groups, and wellness education) on primary outcomes of participant and partner quality of life and self-efficacy. In this unique 10-day multicomponent intervention, groups of couples were randomized to have one of the five interventions withheld while receiving the other four. Although the longitudinal follow-up is still under way, enrollment results are available and reported.

Results: In total, 272 couples have been enrolled in the trial and follow-up visits continue. Outcomes will be assessed at the end-of-intervention and 6-, 12-, and 18-month follow-ups. We anticipate reporting on our primary and secondary outcomes across time points in the next 2 years.

Conclusions: This paper describes the protocol for a randomized comparative effectiveness study of behavioral interventions to prevent or delay dementia. We describe of the rationale, design, power analysis, and analysis plan. Also because enrollment is complete and we are in follow-up phases of the study, we have included enrollment data from the trial.

Trial registration: ClinicalTrials.gov NCT02265757; http://clinicaltrials.gov/ctsshow/ NCT02265757 (Archived by WebCite at http://www.webcitation.org/6ueRfwSYv).

Keywords: behavioral research; cognition disorders; dementia; secondary prevention.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Recruitment and enrollment.
See this image and copyright information in PMC

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