Effect of a Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial
Open accessAbstract
Importance: Persistently poorly controlled type 2 diabetes (PPDM) is common and causes poor outcomes. Comprehensive telehealth interventions could help address PPDM, but effectiveness is uncertain, and barriers impede use in clinical practice. Objective: To address evidence gaps preventing use of comprehensive telehealth for PPDM by comparing a practical, comprehensive telehealth intervention to a simpler telehealth approach. Design, Setting, and Participants: This active-comparator, parallel-arm, randomized clinical trial was conducted in 2 Veterans Affairs health care systems. From December 2018 to January 2020, 1128 outpatients with PPDM were assessed for eligibility and 200 were randomized; PPDM was defined as maintenance of hemoglobin A1c (HbA1c) level of 8.5% or higher for 1 year or longer despite engagement with clinic-based primary care and/or diabetes specialty care. Data analyses were preformed between March 2021 and May 2022. Interventions: Each 12-month intervention was nurse-delivered and used only clinical staffing/resources. The comprehensive telehealth group (n = 101) received telemonitoring, self-management support, diet/activity support, medication management, and depression support. Patients assigned to the simpler intervention (n = 99) received telemonitoring and care coordination. Main Outcomes and Measures: Primary (HbA1c) and secondary outcomes (diabetes distress, diabetes self-care, self-efficacy, body mass index, depression symptoms) were analyzed over 12 months using intent-to-treat linear mixed longitudinal models. Sensitivity analyses with multiple imputation and inclusion of clinical data examined the impact of missing HbA1c measurements. Adverse events and intervention costs were examined. Results: The population (n = 200) had a mean (SD) age of 57.8 (8.2) years; 45 (22.5%) were women, 144 (72.0%) were of Black race, and 11 (5.5%) were of Hispanic/Latinx ethnicity. From baseline to 12 months, HbA1c change was -1.59% (10.17% to 8.58%) in the comprehensive telehealth group and -0.98% (10.17% to 9.19%) in the telemonitoring/care coordination group, for an estimated mean difference of -0.61% (95% CI, -1.12% to -0.11%; P = .02). Sensitivity analyses showed similar results. At 12 months, patients receiving comprehensive telehealth had significantly greater improvements in diabetes distress, diabetes self-care, and self-efficacy; no differences in body mass index or depression were seen. Adverse events were similar between groups. Comprehensive telehealth cost an additional $1519 per patient per year to deliver. Conclusions and Relevance: This randomized clinical trial found that compared with telemonitoring/care coordination, comprehensive telehealth improved multiple outcomes in patients with PPDM at a reasonable additional cost. This study supports consideration of comprehensive telehealth implementation for PPDM in systems with appropriate infrastructure and may enhance the value of telehealth during the COVID-19 pandemic and beyond. Trial Registration: ClinicalTrials.gov Identifier: NCT03520413.
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Health behavior change approaches may be delivered via digital health tools.
“These approaches may be delivered via digital health tools (309,313,315).”
From 5. Facilitating Positive Health Behaviors and Well-being to Improve Health Outcomes:<i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [313]
Health behavior change strategies may be delivered by mental health professionals, DCES, other trained health care professionals, or qualified community health workers.
“Health behavior change strategies may be delivered by mental health professionals, DCES, or other trained health care professionals (307,312-314) or qualified community health workers (307,308).”
From 5. Facilitating Positive Health Behaviors and Well-being to Improve Health Outcomes:<i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [313]
Various health care professionals working with people with diabetes may contribute to psychosocial care in different ways based on training, experience, need, and availability.
“Various health care professionals working with people with diabetes may contribute to psychosocial care in different ways based on training, experience, need, and availability (313,326,327).”
From 5. Facilitating Positive Health Behaviors and Well-being to Improve Health Outcomes:<i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [313]
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- Authors
- Crowley, M. J., Tarkington, P. E., Bosworth, H. B., Jeffreys, A. S., Coffman, C. J., Maciejewski, M. L., Steinhauser, K., Smith, V. A., Dar, M. S., Fredrickson, S. K., Mundy, A. C., Strawbridge, E. M., Marcano, T. J., Overby, D. L., Majette Elliott, N. T., Danus, S., & Edelman, D.
- Affiliations
- Duke University (US)
- Central Virginia Veterans Affairs Health Care System, Richmond
- Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham, North Carolina
- East Carolina University (US)
- ORCID
- Venue
- JAMA Internal Medicine
- Publisher
- American Medical Association (AMA)
- Published
- 2022-09-01
- Volume
- 182
- Issue
- 9
- Pages
- 943
- ISSN
- 2168-6106 (ISSN-L)
- PMC
- PMC9315987
- OpenAlex
- W4287447044
- Cited by
- 75
- References
- 55
- Citations by year
- 2026: 22 · 2025: 20 · 2024: 17 · 2023: 13 · 2022: 3
- FWCI
- 11.68
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- JAMA Internal Medicine (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Department of Veterans Affairs (I01 HX002339, IK2 HX001514)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- uncontrolled diabetes, telehealth intervention, remote patient monitoring, care coordination, HbA1c, diabetes self-management support, diabetes distress, diabetes self-efficacy, depression, veterans, nursing care delivery, medication management, intervention costs, telehealth adoption barriers, health equity, racial and ethnic disparities
- MeSH terms
- COVID-19, Diabetes Mellitus, Type 2, Female, Glycated Hemoglobin, Humans, Male, Middle Aged, Telemedicine, Pandemics
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