Results Summary
What was the research about?
Patients with mild cognitive impairment, or MCI, have problems with memory, language, and thinking. These problems differ from the usual problems caused by aging. Doctors sometimes recommend activities to improve patients’ memory and ability to perform daily tasks.
In this study, the research team looked at combinations of five activities and their effect on quality of life for patients with MCI:
- Training about reminders. Patients learned to use a combined calendar, to-do list, and journaling tool to help them remember tasks and events.
- Brain training app. Patients and partners did activities on tablet computers to improve thinking.
- Physical exercise. Patients and their partners took yoga classes from trained instructors. Classes included breathing exercises and meditation.
- Support groups. Patients met in groups to talk about how MCI affected their lives. Patients’ partners met to talk about caregiving.
- Health classes. Patients and their partners attended group classes. Topics included sleep health, nutrition, exercise, and healthy brain aging.
The research team compared five groups of patients with MCI. Each group completed four of the five activities. For example, one group did all activities except exercise. Another group did all activities except the brain training app.
What were the results?
After one year, patients in the five groups had similar improvement in
- Quality of life
- Confidence in managing MCI
- How well they could do daily activities requiring memory
Compared with all patients, patients who didn’t receive health classes reported worse mood. Patients who didn’t use brain training apps reported better mood.
Who was in the study?
The study included 272 patients with MCI and their partners. All received care at one of four clinics in Minnesota, Florida, Arizona, and Washington State. The average age was 75, and all patients were white and non-Hispanic. Patients had an average of 16 years of schooling.
What did the research team do?
The research team assigned patients by chance to one of the five groups. Patients did the activities for four hours each day for 10 days over two weeks.
Patients filled out a survey before they started the activities, right after the activities, and again one year later. At the same times, patients’ partners filled out a survey on how well patients could do daily activities requiring memory.
Patients and partners of patients with MCI helped design the study.
What were the limits of the study?
Patients in the study were white and well educated. Results may differ for patients of other backgrounds. Because the study didn’t include a group of patients who did not receive activities, the research team can’t be sure that the improvements were a result of the activities and not something else.
Future research could continue to examine ways to improve quality of life for patients with MCI.
How can people use the results?
Patients with MCI, their partners, and doctors can use the results when considering how to improve patient quality of life.
Professional Abstract
Objective
To compare the effectiveness of five behavioral interventions on improving quality of life, mood, self-efficacy, and performance of memory-based activities of daily living for patients with mild cognitive impairment (MCI)
Study Design
| Design Elements | Description |
|---|---|
| Design | Cluster randomized trial |
| Population | 272 patients with MCI and their partners |
| Interventions/ Comparators |
|
| Outcomes |
Primary: patient-reported quality of life Secondary: patient-reported mood and self-efficacy in managing MCI; partner-reported performance of memory-based activities of daily living |
| Timeframe | 1-year follow-up for primary outcome |
This cluster randomized trial compared the effectiveness of five commonly used behavioral interventions on improving quality of life and other outcomes for patients with MCI.
Researchers randomized patients to one of five groups. Each group received four of the five interventions in classes at medical outpatient centers. For example, one group received all interventions except physical exercise; another group received all interventions except computerized cognitive training. Over a two-week period, patients received four hours of the interventions each day for 10 days. The interventions were
- Memory compensation training. Patients learned to use a combined calendar, to-do list, and journaling tool to help them remember tasks and events.
- Computerized cognitive training. Patients and partners did activities on tablet computers to improve cognition.
- Physical exercise. Patients and partners took yoga classes, led by trained instructors, that included breathing exercises and meditation.
- Patient and partner support groups. Patients met in groups to talk about their MCI and how it affected their lives. Partners of patients with MCI met in separate groups to talk about caregiving.
- Classes on learning to live with cognitive impairment. Patients and partners attended group classes on topics like sleep health, nutrition, exercise, and healthy brain aging.
The study included 272 patients with MCI and their partners who received care at one of four outpatient medical centers in Minnesota, Florida, Arizona, and Washington State. All patients were white and non-Hispanic. The average age was 75, and patients had an average of 16 years of schooling.
Before starting the interventions, right after the intervention, and then one year later, patients completed a survey on quality of life, mood, and self-efficacy. At the same times, patients’ partners completed surveys on how well patients performed memory-based activities of daily living.
Patients and partners of patients with mild cognitive impairment helped design the study.
Results
After one year, patients in the five groups showed similar improvement in patient-reported quality of life and self-efficacy and partner-reported memory-based activities of daily living.
For patient-reported mood, patients in two groups showed differences from the average of all patients. Patients who did not receive classes on learning to live with cognitive impairment reported worse mood (p=0.01), and patients who did not receive computerized cognitive training reported better mood (p=0.01).
Limitations
Study participants were white and well educated. Results may differ for patients of other backgrounds. Without a no-treatment comparison, this study cannot establish with certainty that improvement from before to after the interventions was a result of those interventions.
Conclusions and Relevance
In this study, researchers did not observe a relationship between the five interventions and patient quality of life, self-efficacy, and memory-based activities of daily living. However, patient-reported mood differed across the intervention groups.
Future Research Needs
Future research could continue to examine ways to improve quality of life for patients with MCI.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers indicated that the interpretability of this research was limited because the intervention was not compared to a control group. Instead, the investigators compared different iterations of the multi-part intervention. The researchers pointed out that they did not need to include a control or usual care group in a comparative effectiveness trial, since they were comparing different iterations of the intervention.
- The reviewers asked if the researchers had any concern about patients being well enough to participate in the study after several years. The researchers said many patients did decline and more partners than patient participants responded over time.
- The reviewers noted that this study’s broader outcomes like quality of life, the main outcome in this study, were problematic even though the reviewers applauded the researchers for identifying outcomes most important to patients. The reviewers explained that with this type of outcome, it would be difficult to find a way to alter the intervention in order to improve its effect on the outcome. The researchers countered that if a study focused on more mechanistic outcomes, such as brain atrophy in the case of cognitive impairment, and did not improve quality of life, the intervention would be of little value to patients. The researchers pointed out that intervention studies designed to understand the mechanisms of the intervention were different types of trials and did not represent what this study aimed to accomplish.
- The reviewers asked how the individual components of the Mayo Clinic intervention were chosen given that there are other components that have been successful in improving outcomes for this population. Specifically, they asked why aerobic physical activity was not considered. The researchers responded that yoga, a component of the intervention, is indeed an aerobic physical activity and was chosen over other activities such as walking and running because of its adaptability to the condition of participants. The researchers did not respond to the original question of how they decided to use the specific components that they included in the intervention.
- The reviewers said it was not clear to what extent participants remained engaged with the activities in the intervention. The researchers said they collected data on treatment adherence but noted that some activities required less commitment than others (e.g., attending a one-hour support group once a month versus. completing three and half hours of physical exercise each week). So, comparing adherence across treatment groups is challenging. The researchers said they are continuing to study how to compare adherence across study arms but that in this study analyzing adherence did not appreciably change their findings.
- The reviewers noted that the patient groups ranked outcomes in importance based on group input, whereas individuals presumably ranked outcomes differently, and differences in what patients regarded as important might have affected outcomes across individuals. The researchers strenuously agreed. They said that they included and analyzed a range of outcomes in this trial partly so it will be possible in the future to tailor interventions according to the priorities of individual patients.
Conflict of Interest Disclosures
Project Information
Key Dates
Study Registration Information
^Glenn E. Smith was affiliated with the Mayo Clinic when this project was funded.