Results Summary
What was the research about?
Patients diagnosed with type 2 diabetes usually receive information about how to manage their illness over time. Additional support may help patients feel more confident about managing diabetes and other health problems that may arise.
In this study, the research team tested a three-month program that included
- Nurse coaches. Coaches worked one-on-one with patients to set goals for managing their diabetes. They then helped patients create and follow a plan to meet these goals. Patients and their coaches talked about patients’ progress on the phone every two weeks for three months.
- Fitness-tracking devices. Patients received a fitness-tracking device to record daily activity, heart rate, and hours of sleep. They could view these data using a smartphone app or their computer. Patients’ primary care providers could also see this information in the patients’ electronic health records.
The team compared patients in the program with patients receiving only usual care from their primary care providers.
What were the results?
After the three-month program, compared with patients who received only usual care, patients in the program had greater
- Increases in confidence to manage diabetes
- Decreases in depression
But six months after the program ended, patients in the program and those receiving usual care no longer differed in improvement in confidence or depression.
Patients in the program and those receiving usual care didn’t differ in levels of stress, physical function, or anxiety at any time during the study.
Who was in the study?
The study included 319 patients with diabetes from three clinics in Davis, California. Of these patients, 63 percent were white, 13 percent were African American, 9 percent were Asian, 10 percent were another race, and 6 percent were more than one race. Also, 15 percent were Hispanic or Latino. The average age was 59, and 53 percent were men.
What did the research team do?
The research team assigned patients, by chance, to take part in the program or to receive only usual care. Patients filled out surveys at the start of the study and again three and nine months later. The survey asked about patients’ confidence in managing diabetes, stress, anxiety, and depression.
Patients with diabetes, primary care providers, specialists, dietitians, and computer scientists helped design the program. They also helped recruit patients and interpret results.
What were the limits of the study?
Patients were in the program for three months. Results may be different if patients were in the program for a longer time.
Future research can study how to sustain the results from the program for a longer time.
How can people use the results?
Clinics can use the results when considering programs to help patients manage diabetes.
Professional Abstract
Objective
To compare the effectiveness of a program that included nurse coaching, mobile health technology, and usual care versus usual care alone on improving patients’ self-efficacy for managing type 2 diabetes
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 319 patients with type 2 diabetes treated at 3 primary care clinics at UC Davis Health, a primary care network |
| Interventions/ Comparators |
|
| Outcomes |
Primary: patient-reported self-efficacy in managing diabetes Secondary: depression, stress, physical function, anxiety |
| Timeframe | 9-month follow-up for primary outcome |
This randomized controlled trial compared the effectiveness of a nurse coaching program with mobile health technology plus usual care versus usual care alone on improving patients’ self-efficacy in managing diabetes and levels of depression, physical function, and stress.
The research team randomly assigned patients to the program plus usual care or to usual care alone. In the program, patients had phone calls with nurse coaches every two weeks for three months. The coaches worked with patients to set personal health and activity goals and discussed progress toward the goals. Patients also received a fitness-tracking device, which collected information such as daily steps taken, heart rate, and hours of sleep. The device sent the information to an app on a smartphone or computer, where patients could review it. Clinicians were also able to review this information in patients’ electronic health records. Usual care consisted of standard healthcare visits.
The study included 319 patients with type 2 diabetes receiving care at three primary care clinics at UC Davis Health, a primary care network. Of these patients, 63% were white, 13% were African American, 9% were Asian, 10% were another race, and 6% were more than one race; 15% were Hispanic or Latino. The average age was 59, and 53% were male.
The research team surveyed patients on self-efficacy in managing diabetes, depression, stress, physical function, and anxiety at baseline and again three and nine months later.
Patients with diabetes, primary care clinicians, specialists, dietitians, and computer scientists helped design the program, recruit participants, and interpret results.
Results
At three months, when the program ended, patients in the program had greater improvements in self-efficacy for managing diabetes (p<0.001) and reductions in depression (p=0.048) than patients who received usual care alone. However, six months later, the two groups did not differ in the amount of improvement in these outcomes.
Patients in the two groups did not differ significantly in changes in stress, physical function, or anxiety at either time point.
Limitations
Patients received the nurse coaching program for three months. Results may have been different if patients had received the program for a longer period.
Conclusions and Relevance
Compared with usual care alone, adding a three-month nurse coaching program paired with mobile health technology to patients’ usual care improved self-efficacy and depression at three months. These improvements were not maintained six months later.
Future Research Needs
Future research could determine how to sustain improvements in outcomes from this program for longer periods.
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 expressed concern that the report did not present enough information about the study methods, particularly the interventions, to satisfy standard reporting guidelines and PCORI Methodology Standards. The researchers added text to better explain their methods and revised the structure of the report to consolidate their description of the compared interventions, as well as to help the narrative flow more logically.
- The reviewers expressed concern about the inconsistency between the primary and secondary outcomes described in the report, which had one primary outcome and the rest secondary, and the outcomes described in the clinical trial registry, which included eight primary outcomes. They also stressed the necessity to report all of the results for preplanned outcomes and analyses, even for outcomes that showed no effect. The researchers revised the final report to include all of the preplanned outcomes. They also updated the primary outcomes listed in the clinical trial registry so that the final report and the registry information were consistent in describing 3 primary outcomes, with 12 more secondary outcomes.
- The reviewers asked the researchers to expand the background of the report to present the evidence of a need for a behavioral intervention, such as the one tested in the study. The researchers added text and references, noting that they had conducted a systematic review before conducting their study. They cited the Centers for Disease Control and Prevention in noting that healthy eating and physical activity are core clinical recommendations for managing type 2 diabetes.
- The reviewers suggested that a technology recall affecting a large number of participants and the addition of a third clinic to the trial because of slow recruitment should be considered setbacks and therefore, weaknesses of the study. The researchers disagreed that these two issues represented setbacks. The issues had been anticipated when designing the study, so the researchers had adopted a platform that would allow for evolving technology. Also, the researchers noted that the third clinic that was added was part of the same primary care network, and shared common systems and oversight. The researchers also disagreed that the study had a relatively high drop-out rate, saying that the attrition rate was below the average in clinical trials.