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 |
- mHealth alone
- Community health workers alone
- mHealth plus community health workers
|
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.