Selected Study: Gerber, B. S., Biggers, A., Tilton, J. J., Smith Marsh, D. E., Lane, R., Mihailescu, D., Lee, J., & Sharp, L. K. (2023). Mobile Health Intervention in Patients with Type 2 Diabetes: A Randomized Clinical Trial. JAMA network open, 6(9), e2333629. https://doi.org/10.1001/jamanetworkopen.2023.33629
The randomized controlled trial (RCT) conducted by Gerber et al. (2023) examined the effectiveness of a team-based mobile health intervention designed to improve glycemic control among African American and Latinx adults with poorly controlled type 2 diabetes and elevated HbA1c.
Purpose
The purpose of this study trial was to determine whether a mobile health intervention delivered by a clinical pharmacist and health coach could improve hemoglobin A1c levels compared with usual diabetes care (Gerber et al., 2023).
Study Population
The study population included 221 adults aged 21 to 75 years who self-identified as African American or Latinx and had an HbA1c level of 8 percent or higher at baseline (HbA1c ≥ 8%). Participants were recruited from an academic medical center and affiliated federally qualified health centers, which enhanced relevance to underserved populations (Gerber et al., 2023).
Length of the Trial
Participants were randomly assigned from March 2017 to January 2020 to either the intervention group or a waiting-list control group. The trial spanned 24 months, with the intervention group primary comparison occurring during the first 12 months and then returned to monitored usual care for the second year. The control group received usual care for 12 months and then received the intervention in year 2 (a waiting-list approach) (Gerber et al., 2023). Data was collected at baseline and at six-month intervals using both clinical measures and validated patient-reported instruments. The primary outcome was changed in HbA1c, while secondary outcomes included blood pressure, lipid levels, body mass index, and psychosocial measures such as diabetes distress and self-efficacy.
Data Collection Methods
Outcomes were assessed every 6 months. Data collection included clinical measures (HbA1c, blood pressure, cholesterol, BMI) and patient-reported measures (quality of life, diabetes distress, self-efficacy, depressive symptoms, social support, medication-taking behavior, and self-care) (Gerber et al., 2023).
At 12 months, the intervention group demonstrated a greater reduction in HbA1c compared with the control group. The authors reported a mean difference of −0.62 percentage points favoring the intervention, with a statistically significant confidence interval. During the second year, when the control group received the intervention, similar improvements were observed, and the original intervention group maintained glycemic gains. The authors concluded that the intervention was effective and could help reduce disparities in diabetes outcomes (Gerber et al., 2023).
Outcome Measures
The primary outcome was HbA1c. Secondary outcomes included cardiometabolic measures and psychosocial and self-management measures (Gerber et al., 2023).
Results and Conclusions
Over 12 months, HbA1c decreased by a mean of 0.79 percentage points in the intervention group versus 0.24 percentage points in the waiting-list control group. The reported treatment effect was −0.62 (95% CI, −1.04 to −0.19; P = .005). During year 2, the waiting-list group’s HbA1c improved after receiving the intervention, while the original intervention group-maintained gains (Gerber et al., 2023). The authors concluded that the intervention improved HbA1c and could help reduce disparities in glycemic outcomes for these populations (Gerber et al., 2023).
Ethical Issues Associated with this Randomized Control Trial Study
Several ethical considerations are relevant. First, withholding a potentially helpful intervention can be a concern in randomized trials, particularly when studying groups are experiencing inequities. A key ethical feature here is the waiting-list control, which limited long-term deprivation by offering the intervention to the control group after 12 months (Gerber et al., 2023).
Second, the intervention included home visits and text messaging, which raises privacy and confidentiality issues. Ethical conduct requires clear consent processes and safeguards for health information shared through telehealth platforms and messaging (Gerber et al., 2023).
Third, participant burden and potential coercion must be considered, especially when working with underserved communities. From a population-based nursing perspective, ethical research should minimize barriers and avoid placing disproportionate burdens on participants who already face structural constraints (Curley, 2024).
Value of the Randomized Control Trial
Randomization strengthens internal validity by balancing measured and unmeasured confounders between groups, which improves confidence that observed HbA1c differences are attributable to the intervention rather than systematic baseline differences. This is a primary advantage of experimental designs compared with observational approaches when evaluating intervention effectiveness (Friis & Sellers, 2021).
References
Curley, A. L. C. (Ed.). (2024). Population-based nursing: Concepts and competencies for
advanced practice (4th ed.). Springer.
Friis, R. H., & Sellers, T. A. (2021). Epidemiology for public health practice (6th ed.). Jones &
Bartlett Learning.
Gerber, B. S., Biggers, A., Tilton, J. J., Smith Marsh, D. E., Lane, R., Mihailescu, D., Lee, J., &
Sharp, L. K. (2023). Mobile Health Intervention in Patients with Type 2 Diabetes: A Randomized Clinical Trial. JAMA network open, 6(9), e2333629. https://doi.org/10.1001/jamanetworkopen.2023.33629