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.

Final Research Report

View this project's final research report.

More About This Research

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

View the COI disclosure form.

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

Glenn E. Smith, PhD
University of Florida^
$2,072,271
10.25302/12.2020.CER.1306-01897IC

Key Dates

49 months
December 2013
June 2020
2013
2020

Study Registration Information

^Glenn E. Smith was affiliated with the Mayo Clinic when this project was funded.

Tags

Has Results
Project Status
Award Type
Health Conditions

Health Conditions

These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them.

View Glossary
Populations

Populations

PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders.

View Glossary
Funding Opportunity Type
Intervention Strategy

Intervention Strategies

PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care.

View Glossary
Research Priority Area
State

State

The state where the project originates, or where the primary institution or organization is located.

View Glossary
Last updated: October 20, 2021