Results Summary
What was the research about?
Type 2 diabetes is a long-term illness that causes blood sugar levels to rise. Diabetes causes many health problems and can be hard to manage. It is the seventh leading cause of death in the United States. Many patients use diet, exercise, and medicines to control diabetes. But less than seven percent of patients with diabetes manage it effectively.
The research team compared three ways to help patients with Medicaid manage their diabetes:
- Daily cell phone interactive text message reminders
- Talking to a community health worker with diabetes, a person trained to help others with diabetes get the health care they need
- Both daily text messages and talking to a community health worker
What were the results?
The study found that all three methods worked about the same to improve patients’ health and encourage healthy behaviors.
At the end of the study, patients in all three groups met more of their healthcare goals. They also had lower blood sugar and cholesterol levels. In addition, patients were more likely to monitor their blood pressure than at the start of the study, and their worry about diabetes decreased. Patients had fewer hospital and urgent care visits but didn’t have fewer emergency room visits.
Who was in the study?
The study included 166 patients with type 2 diabetes. Of these, 91 percent were African American, and 9 percent were other races. The average patient age was 53, and 72 percent were women. All patients had Medicaid and received care at one of three clinics in the Washington, DC, area.
What did the research team do?
The research team assigned patients to one of three groups by chance. Patients in the first group received text messages on their cell phones with reminders to check their blood sugar and take their medicine. They also received text messages to encourage behaviors to control their illness. The cell phone app allowed patients to report their blood sugars and activities.
Patients in the second group talked on the phone or in person with a community health worker. At first, community health workers had frequent calls with each patient and often attended patients’ clinic visits. After two months, patients decided how often they would be in contact with the community health worker, mostly once a month. The third group received both text messages and talked with a community health worker. All programs lasted for one year.
The research team collected information about patients at the start of the study and again after a year. The team looked at
- How patients managed their illness
- How often patients needed urgent care or went to the hospital or emergency room
- How much stress diabetes caused the patients
An advisory board made up of patients, a diabetes educator, and representatives of a Medicaid insurer and the American Diabetes Association helped design the study.
What were the limits of the study?
Because the original clinic closed, patients couldn’t meet with community health workers for six weeks. This lapse may have affected the study results. The study included patients from three clinics in Washington, DC. Results may be different for patients in other locations.
Future research could test using text messages and community health workers with other patients in more locations.
How can people use the results?
Doctors’ offices and clinics may consider using text messages or community health workers to help patients with diabetes meet their health goals.
Professional Abstract
Objective
To compare the effectiveness of a cell phone-based mobile health intervention (mHealth) versus meeting with community health workers versus mHealth plus community health workers on patient self-management of type 2 diabetes mellitus
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 166 patients with Medicaid and type 2 diabetes |
| Interventions/ Comparators |
|
| Outcomes |
Primary: meeting wellness and clinical goals Secondary: HbA1c levels, LDL cholesterol, blood pressure monitoring, diabetes distress, hospitalizations, urgent care visits, emergency room visits |
| Timeframe | 12-month follow-up for primary outcome |
This randomized controlled trial compared the effectiveness of an mHealth intervention alone and community health workers alone and in combination on patients’ self-management of type 2 diabetes. The primary outcome was improvement in achieving wellness and clinical goals, including glucose and blood pressure self-monitoring, decreasing body mass index (BMI), regular exercise, smoking cessation, medication adherence, and taking aspirin as prescribed. Other goals included having diabetes care visits, lipid or HbA1c testing, and screening for retinopathy, renal function, and neuropathy.
The study included 166 patients with Medicaid who attended one of three clinics in the Washington, DC, area. The patients had type 2 diabetes and HbA1c levels of ≥8%. Of the patients, 91% were African American, and 9% were other races. The average patient age was 53, and 72% were female. Patients in the study had at least two unmet wellness and clinical goals.
The research team randomized patients to one of three groups:
- mHealth alone. The Voxiva Care4life mHealth diabetes self-management intervention used interactive text messaging to provide patients with daily reminders and personalized coaching messages.
- Community health workers alone. Community health workers with diabetes provided advice and assistance in managing diabetes by phone or in person. During the first two months of the study, community health workers called patients frequently and often attended their clinic visits. Patients then decided how often they would meet with community health workers; most chose once a month.
- mHealth plus community health workers. Patients in this group received both interventions. The community health workers also assisted patients with the use of the mHealth intervention.
At the initial visit with each patient, the team obtained demographic information and baseline data on wellness behaviors. Patients had follow-up visits at 6 and 12 months to assess wellness behaviors and clinical goals.
An advisory board made up of patients, a diabetes educator, and representatives of a Medicaid insurer and the American Diabetes Association helped design the study.
Results
After 12 months, the study found no significant differences among the three groups. In all three groups, patients
- Met more of their wellness and clinical goals (p=0.001)
- Had decreased HbA1c levels (p<0.0001), with 30% of patients across the three groups decreasing HbA1c levels to values of less than 8%
- Had decreased LDL cholesterol levels (p=0.02)
- Were more likely to monitor their blood pressure (p<0.0001)
- Had reduced diabetes distress (p<0.0001)
- Had fewer hospitalizations (p=0.03) and urgent care visits (p=0.03)
- Did not have reductions in emergency room visits
Limitations
Midway through the study, the research team replaced all the community health workers because the partnering organization closed. This closure resulted in a six-week lapse in contact between patients and community health workers. The lapse may have affected study results.
The study participants were patients with Medicaid in an urban area. Results may not be generalizable to other populations.
Conclusions and Relevance
This study found that mHealth alone, community health workers alone, and mHealth in combination with community health workers all promoted achievement of wellness and clinical goals over 12 months in an urban Medicaid population of patients with diabetes.
Future Research Needs
Future studies could assess the impact of these interventions over a longer time period and with other Medicaid populations. Additional research could also evaluate strategies where patients initially receive community health worker support and then transition to mobile health.
Final Research Report
View this project's final research report.
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 review identified the following strengths and limitations in the report:
- In response to reviewers’ questions about the handling of missing data, the researchers explained that the rate of missing data was low. The researchers also noted that there were no differences between study groups in the amount of missing data or in the characteristics of participants with missing data. Therefore, the researchers assumed that data were missing at random and did not attempt to input data for these participants or conduct sensitivity analyses.
- The reviewers noted that the study did not prove the main hypothesis, which was that the combination of community health worker and mobile health interventions would produce better results than either intervention alone. The researchers revised the discussion and conclusion sections to clarify that point.