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Randomized Controlled Trial
. 2022 Sep 1;182(9):943-952.
doi: 10.1001/jamainternmed.2022.2947.

Effect of a Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial

Matthew J Crowley  1   2 , Phillip E Tarkington  3 , Hayden B Bosworth  1   4   5 , Amy S Jeffreys  1 , Cynthia J Coffman  1   6 , Matthew L Maciejewski  1   4   5   7 , Karen Steinhauser  1   5 , Valerie A Smith  1   4   5 , Moahad S Dar  8   9 , Sonja K Fredrickson  3 , Amy C Mundy  3 , Elizabeth M Strawbridge  1 , Teresa J Marcano  3 , Donna L Overby  3 , Nadya T Majette Elliott  1 , Susanne Danus  1 , David Edelman  1   4
Affiliations
Randomized Controlled Trial

Effect of a Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial

Matthew J Crowley et al. JAMA Intern Med. .

Abstract

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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Conflict of interest statement

Conflict of Interest Disclosures: Dr Crowley reported grants from National Institutes of Health (1R01NR019594-01), VA Quality Enhancement Research Initiative (QUE 20-012), VA Office of Rural Health, and VA Health Services Research & Development (CDA 13-261) outside the submitted work. Dr Bosworth reported research support from Otsuka, Novo Nordisk, Sanofi, Improved Patient Outcomes, Boehringer Ingelheim, National Institutes of Health, and VA, as well as consulting fees from WebMD, Sanofi, Novartis, Otsuka, Abbott, Xcenda, Preventric Diagnostics, VIDYA, and the Medicines Company outside the submitted work. Ms Danus reported grants from Department of Veterans Affairs/VA Health Services Research and Novo Nordisk outside the submitted work. Dr Edelman reported personal fees from Department of Veterans Affairs (salary) outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Comprehensive Telehealth Intervention Design
Adapted with permission from Kobe et al. EHR indicates electronic health record; SMBG, self-monitored blood glucose.
Figure 2.
Figure 2.. Participant Flow
BMI indicates body mass index, calculated as weight in kilograms divided by height in meters squared; HbA1c, hemoglobin A1c; VHA, Veterans Health Administration.
Figure 3.
Figure 3.. Estimated Trajectories by Arm for Hemoglobin A1c (HbA1c) Level, From Linear Mixed Models
Error bars indicate 95% CIs.
See this image and copyright information in PMC

References

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