Comparative Effectiveness of Behavioral Interventions on Quality of Life for Older Adults With Mild Cognitive Impairment: A Randomized Clinical Trial

Abstract

Importance: Recommendations to engage in behavioral strategies to combat clinically significant cognitive and behavioral symptoms are routinely given to persons with mild cognitive impairment (MCI). The comparative effectiveness of these behavioral interventions is not well understood.

Objective: To compare the incremental effects of combinations of 5 behavioral interventions on outcomes of highest importance to patients with MCI.

Design, setting, and participants: In this multisite, cluster randomized, multicomponent comparative effectiveness trial, 272 patients from 4 academic medical outpatient centers (Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Scottsdale, Arizona; Mayo Clinic, Jacksonville, Florida; and University of Washington, Seattle) were recruited from September 1, 2014, to August 31, 2016, with last follow-up March 31, 2019. All participants met the National Institute on Aging-Alzheimer's Association criteria for MCI.

Interventions: The intervention program was modeled on the Mayo Clinic Healthy Action to Benefit Independence and Thinking (HABIT) program, a 50-hour group intervention conducted during 2 weeks, including memory compensation training, computerized cognitive training, yoga, patient and partner support groups, and wellness education. In our study, 1 of 5 interventions was randomly selected to be withheld for each intervention group. Participants and their partners had 1-day booster sessions at 6 and 12 months after intervention.

Main outcomes and measures: Quality-of-life measurement of participants with MCI at 12 months was the primary outcome, selected based on the preference rankings of previous program participants. Mood, self-efficacy, and memory-based activities of daily living were also highly ranked.

Results: A total of 272 participants (mean [SD] age, 75 [8] years; 160 [58.8%] male and 112 [41.2%] female) were enrolled in this study, with 56 randomized to the no yoga group, 54 to no computerized cognitive training, 52 to no wellness, 53 to no support, and 57 to no memory support system. The greatest effect size for quality of life was between the no computerized cognitive training and no wellness education groups at 0.34 (95% CI, 0.05-0.64). In secondary analyses, wellness education had a greater effect on mood than computerized cognitive training (effect size, 0.53; 95% CI, 0.21-0.86), and yoga had a greater effect on memory-related activities of daily living than support groups (effect size, 0.43; 95% CI, 0.13-0.72).

Conclusions and relevance: These results provide further support for behavioral interventions for persons with MCI. Different outcomes were optimized by different combinations of interventions. These findings provide an initial exploration of the effect of behavioral interventions on patient-advocated outcomes in persons with MCI.

Trial registration: ClinicalTrials.gov identifier: NCT02265757.

Conflict of interest statement

Conflict of Interest Disclosures: Drs Chandler, Locke, Crook, Fields, Ball, and Smith reported receiving grants from Patient-Centered Outcomes Research Institute (PCORI) during the conduct of the study. Dr Locke reported receiving grants from the National Institutes of Health and the State of Arizona outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Recruitment CONSORT Chart

AZ indicates Arizona; CCT, computerized cognitive training; FL, Florida; MCI, mild cognitive impairment; MN, Minnesota; MSS, memory support system; and WA, Washington.

Figure 2.. Effect Sizes by Study Arm and Intervention

Effect sizes were estimated from linear mixed-effects regression models, in which a 1-unit increase in the effect size corresponded to a 1-SD improvement in patient outcome. Baseline SDs were 5.59 for quality of life (QOL) (A), 4.95 for memory-related activities of daily living (mADLs) (D), 8.11 for mood (B), and 14.00 for self-efficacy (C). Treatment occurred for 10 days over a 2-week period. CCT indicates computerized cognitive training; EOT, end of treatment; and MSS, memory support system. Error bars represent 95% CIs for the effect sizes.