Background
Chronic diseases like type 2 diabetes (T2D) complicated by hypertension are major public health concerns requiring innovative care models. While comprehensive telehealth—integrating remote monitoring and nurse-led support—has shown promise in integrated health systems, its application in predominantly fee-for-service (FFS) environments remains sparse. Understanding the effectiveness and implementation challenges in FFS systems is vital as these models vastly differ from integrated systems in care coordination and reimbursement structures.
Objective
This study aimed to assess the clinical effectiveness and real-world implementation of a comprehensive telehealth program delivered by nurses in an FFS setting for patients with poorly controlled T2D and concomitant hypertension.
Study Design and Setting
A pragmatic, randomized, effectiveness-implementation trial (ClinicalTrials.gov: NCT05120544) was conducted across six academic primary care and endocrinology clinics. Such a design ensures evaluation under usual care conditions, reflecting daily clinical practice rather than ideal or tightly controlled environments.
Participants
Eligible participants had T2D with hemoglobin A1c (HbA1c) ≥8.0% for at least six months and hypertension evidenced by at least one systolic blood pressure (SBP) >140 mm Hg or diastolic blood pressure (DBP) >90 mm Hg in the past year. The cohort’s average age was 54.5 years, predominantly female (64%) and African American (68%), with mean baseline HbA1c of 9.8% and blood pressure averaging 135/81 mm Hg, reflecting a population with significant disease burden and health disparities.
Intervention
Participants were randomized to one of two 12-month interventions:
- Control group: A self-monitoring program enabling patients to record and track their own glucose and blood pressure readings via mobile technology, without additional therapeutic interventions.
- Intervention group: A comprehensive telehealth program, nurse-delivered and mobile monitoring-enabled, combining self-management support and medication management. Nurses provided tailored education, behavioral support, and coordinated medication adjustments in collaboration with healthcare providers.
Measurements and Outcomes
The primary endpoint was change in HbA1c at 12 months. Secondary outcomes included blood pressure control, diabetes self-care behaviors, and fidelity and barriers to program implementation—critical for understanding both clinical efficacy and practical application.
Results
Both groups experienced reductions in HbA1c over 12 months: the control group saw a decrease of 0.7 percentage points, while the comprehensive telehealth group improved by 1.1 points. The between-group difference of -0.4 percentage points did not reach statistical significance (95% CI, -1.0 to 0.3). Secondary outcomes showed no significant differences except diabetes self-care improved modestly in the comprehensive telehealth group (mean difference 0.4; 95% CI, 0.0 to 0.9), indicating enhanced patient engagement. Blood pressure changes were not significantly different.
The program’s delivery fidelity was suboptimal, with a median of 9 nurse contacts per participant versus a fidelity threshold of 12 or more. Barriers identified included scheduling difficulties, limited nurse time, technological challenges, and patient engagement variability. These factors likely attenuated the intervention’s potential impact.
Limitations
Results may not generalize to other populations or healthcare systems, especially those without existing telehealth infrastructure. Furthermore, the design and components of both the intervention and control programs, alongside variable patient adherence, may have influenced outcomes.
Conclusion
In a fee-for-service setting, comprehensive nurse-led telehealth did not significantly reduce HbA1c compared to self-monitoring alone in patients with uncontrolled T2D and hypertension. While the intervention modestly improved self-care behaviors, system-level and implementation barriers curtailed its effectiveness. Future programs may benefit from addressing these barriers, optimizing intervention fidelity, and adapting to specific population needs to enhance chronic disease management.
Clinical Implications and Future Directions
This study highlights the complexity of translating telehealth-driven chronic disease management into FFS environments. Important considerations include reimbursement policies for nurse-led telehealth, integration of remote monitoring data into clinical workflows, and patient-centered strategies to boost engagement and adherence. Further research should explore tailored interventions that overcome these challenges and evaluate long-term outcomes, cost-effectiveness, and scalability.
Funding and Acknowledgments
The trial was funded primarily by the National Institute of Nursing Research and the Duke Clinical & Translational Science Institute. The multidisciplinary research team involved nurse clinicians, endocrinologists, and health services researchers dedicated to advancing technology-enabled chronic disease care.