TY - JOUR
AU - M. J. Crowley
AU - A. A. Lewinski
AU - Q. Yang
AU - D. Hatch
AU - A. Palipana
AU - H. B. Bosworth
AU - B. G. Kaufman
AU - R. Chatterjee
AU - G. Pennington
AU - D. Matters
AU - D. Lee
AU - D. Urlichich
AU - H. N. Miller
AU - J. German
AU - S. Sang
AU - B. Smith
AU - S. Kokosa
AU - P. Gregory
AU - C. L. Roberson
AU - H. Canupp
AU - R. J. Shaw
A1 - 
AB - BACKGROUND: Comprehensive telehealth is used effectively for treatment-resistant chronic diseases in certain integrated health systems but has seldom been implemented in systems that provide mainly fee-for-service (FFS) care. OBJECTIVE: To examine the effectiveness and implementation of comprehensive telehealth delivered in an FFS environment for patients with uncontrolled type 2 diabetes (T2D) and comorbid hypertension. DESIGN: Pragmatic, randomized, effectiveness-implementation trial. (ClinicalTrials.gov: NCT05120544). SETTING: 6 academic primary care or endocrinology clinics. PARTICIPANTS: Participants had both T2D with hemoglobin A(1c) (HbA(1c)) persistently at 8.0% or higher for at least 6 months and hypertension with at least 1 systolic blood pressure (BP) above 140 mm Hg or diastolic BP above 90 mm Hg in the past year. INTERVENTION: Two 12-month, mobile monitoring-enabled interventions: a self-monitoring control program and a nurse-delivered, comprehensive telehealth program incorporating self-management support and medication management. MEASUREMENTS: Primary (HbA(1c)) and secondary outcomes were evaluated at 12 months. Implementation analyses evaluated fidelity and barriers to intervention delivery. RESULTS: Participants were 64% female and 68% Black. The mean age was 54.5 years, mean HbA(1c) 9.8%, and mean BP 135/81 mm Hg. The estimated mean change in HbA(1c) from 0 to 12 months was -0.7 percentage points with self-monitoring and -1.1 percentage points with comprehensive telehealth; the estimated mean between-group difference in HbA(1c) change at 12 months was -0.4 percentage points (95% CI, -1.0 to 0.3 percentage points). Between-group differences in change in secondary outcomes did not reach statistical significance, except for diabetes self-care (0.4 [CI, 0.0 to 0.9], favoring comprehensive telehealth). The comprehensive program was delivered with suboptimal fidelity (median encounters per participant, 9; fidelity threshold, ≥12); analyses identified barriers to program delivery. LIMITATION: Generalizability to dissimilar populations and systems lacking telehealth infrastructure may be limited. CONCLUSION: Comprehensive telehealth did not substantially lower HbA(1c) relative to control in this study. Population factors, intervention and control program design, and barriers to FFS implementation of comprehensive telehealth may have contributed to these findings. PRIMARY FUNDING SOURCE: National Institute of Nursing Research and Duke Clinical & Translational Science Institute.
AD - Division of Endocrinology, Department of Medicine, Duke University School of Medicine, and Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Medical Center, Durham, North Carolina (M.J.C., J.G.).; Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Medical Center, and School of Nursing, Duke University, Durham, North Carolina (A.A.L.).; School of Nursing, Duke University, Durham, North Carolina (Q.Y., D.H., A.P., G.P., D.M., D.L., D.U., S.S., R.J.S.).; Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Medical Center; School of Nursing, Duke University; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine; and Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina (H.B.B.).; Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham Veterans Affairs Medical Center; Department of Population Health Sciences, Duke University School of Medicine; and Duke-Margolis Institute for Health Policy, Duke University, Durham, North Carolina (B.G.K.).; Division of General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, North Carolina (R.C.).; School of Nursing, Johns Hopkins University, Baltimore, Maryland (H.N.M.).; Department of Pharmacy, Duke University Health System, Durham, North Carolina (B.S., P.G., C.L.R., H.C.).; Division of Endocrinology, Department of Medicine, Duke University School of Medicine, and Department of Pharmacy, Duke University Health System, Durham, North Carolina (S.K.).
AN - 42330500
BT - Ann Intern Med
C5 - HIT & Telehealth; Education & Workforce
CP - 7
DA - 07/2026
DO - 10.7326/annals-26-00132
DP - NLM
ET - 20260623
IS - 7
JF - Ann Intern Med
LA - eng
N2 - BACKGROUND: Comprehensive telehealth is used effectively for treatment-resistant chronic diseases in certain integrated health systems but has seldom been implemented in systems that provide mainly fee-for-service (FFS) care. OBJECTIVE: To examine the effectiveness and implementation of comprehensive telehealth delivered in an FFS environment for patients with uncontrolled type 2 diabetes (T2D) and comorbid hypertension. DESIGN: Pragmatic, randomized, effectiveness-implementation trial. (ClinicalTrials.gov: NCT05120544). SETTING: 6 academic primary care or endocrinology clinics. PARTICIPANTS: Participants had both T2D with hemoglobin A(1c) (HbA(1c)) persistently at 8.0% or higher for at least 6 months and hypertension with at least 1 systolic blood pressure (BP) above 140 mm Hg or diastolic BP above 90 mm Hg in the past year. INTERVENTION: Two 12-month, mobile monitoring-enabled interventions: a self-monitoring control program and a nurse-delivered, comprehensive telehealth program incorporating self-management support and medication management. MEASUREMENTS: Primary (HbA(1c)) and secondary outcomes were evaluated at 12 months. Implementation analyses evaluated fidelity and barriers to intervention delivery. RESULTS: Participants were 64% female and 68% Black. The mean age was 54.5 years, mean HbA(1c) 9.8%, and mean BP 135/81 mm Hg. The estimated mean change in HbA(1c) from 0 to 12 months was -0.7 percentage points with self-monitoring and -1.1 percentage points with comprehensive telehealth; the estimated mean between-group difference in HbA(1c) change at 12 months was -0.4 percentage points (95% CI, -1.0 to 0.3 percentage points). Between-group differences in change in secondary outcomes did not reach statistical significance, except for diabetes self-care (0.4 [CI, 0.0 to 0.9], favoring comprehensive telehealth). The comprehensive program was delivered with suboptimal fidelity (median encounters per participant, 9; fidelity threshold, ≥12); analyses identified barriers to program delivery. LIMITATION: Generalizability to dissimilar populations and systems lacking telehealth infrastructure may be limited. CONCLUSION: Comprehensive telehealth did not substantially lower HbA(1c) relative to control in this study. Population factors, intervention and control program design, and barriers to FFS implementation of comprehensive telehealth may have contributed to these findings. PRIMARY FUNDING SOURCE: National Institute of Nursing Research and Duke Clinical & Translational Science Institute.
PY - 2026
SN - 0003-4819 (Print); 0003-4819
SP - 968
EP - 979+
ST - Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care : A Pragmatic, Randomized, Effectiveness-Implementation Trial
T1 - Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care : A Pragmatic, Randomized, Effectiveness-Implementation Trial
T2 - Ann Intern Med
TI - Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care : A Pragmatic, Randomized, Effectiveness-Implementation Trial
U1 - HIT & Telehealth; Education & Workforce
U3 - 10.7326/annals-26-00132
VL - 179
VO - 0003-4819 (Print); 0003-4819
Y1 - 2026
ER -