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

Abstract

BackgroundCurrently, people at risk for dementia and their caregivers are confronted with confusing choices about what behavioral interventions are most effective.ObjectiveThe 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.MethodsThis 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.ResultsIn 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.ConclusionsThis 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)

A Survey of Patient and Partner Outcome and Treatment Preferences in Mild Cognitive Impairment

“…Based on these results we will use patient QoL as the primary outcome in the multi-center randomized comparative effectiveness trial we have underway [ 26 ]. That trial seeks to directly determine the impact of each intervention on the outcomes considered herein.…”

Comparative Effectiveness of Behavioral Interventions on Quality of Life for Older Adults With Mild Cognitive Impairment

“…Full details of the study protocol and recruitment have been reported previously 12 and are summarized below. The trial protocol can be found in Supplement 1 .…”

“… 25 All measures were completed at baseline, treatment end, 6 months after intervention, and 12 months after intervention. Six- and 12-month data collection was part of a 1-day booster session that included a refresher for each of the 4 components originally provided (described further elsewhere 12 ). All outcome data were collected before the commencement of the booster session.…”

Functional ability is associated with higher adherence to behavioral interventions in mild cognitive impairment

“…A complete description of the study protocol was reported by Smith et al (2017) and the primary outcome analysis is reported in . A brief description is summarized below.…”