Dataset Information

A Telehealth-supported, Integrated care with CHWs, and MEdication-access (TIME) Program for Diabetes Improves HbA1c: a Randomized Clinical Trial.

ABSTRACT:

Background

Many individuals with diabetes live in low- or middle-income settings. Glycemic control is challenging, particularly in resource-limited areas that face numerous healthcare barriers.

Objective

To compare HbA1c outcomes for individuals randomized to TIME, a Telehealth-supported, Integrated care with CHWs (Community Health Workers), and MEdication-access program (intervention) versus usual care (wait-list control).

Design

Randomized clinical trial.

Participants

Low-income Latino(a) adults with type 2 diabetes.

Interventions

TIME consisted of (1) CHW-participant telehealth communication via mobile health (mHealth) for 12 months, (2) CHW-led monthly group visits for 6 months, and (3) weekly CHW-physician diabetes training and support via telehealth (video conferencing).

Main measures

Investigators compared TIME versus control participant baseline to month 6 changes of HbA1c (primary outcome), blood pressure, body mass index (BMI), weight, and adherence to seven American Diabetes Association (ADA) standards of care. CHW assistance in identifying barriers to healthcare in the intervention group were measured at the end of mHealth communication (12 months).

Key results

A total of 89 individuals participated. TIME individuals compared to control participants had significant HbA1c decreases (9.02 to 7.59% (-?1.43%) vs. 8.71 to 8.26% (-?0.45%), respectively, p?=?0.002), blood pressure changes (systolic: -?6.89 mmHg vs. 0.03 mmHg, p?=?0.023; diastolic: -?3.36 mmHg vs. 0.2 mmHg, respectively, p?=?0.046), and ADA guideline adherence (p??0.50% HbA1c reductions (88.57% vs. 43.75%, p??1 barrier to care, of whom 91.7% had medication issues. CHWs identified the majority (87.5%) of barriers.

Conclusions

TIME participants resulted in improved outcomes including HbA1c. CHWs are uniquely positioned to identify barriers to care particularly related to medications that may have gone unrecognized otherwise. Larger trials are needed to determine the scalability and sustainability of the intervention.

Clinical trial

NCT03394456, accessed at https://clinicaltrials.gov/ct2/show/NCT03394456.

SUBMITTER: Vaughan EM

PROVIDER: S-EPMC7878600 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Telehealth-supported, Integrated care with CHWs, and MEdication-access (TIME) Program for Diabetes Improves HbA1c: a Randomized Clinical Trial.

Vaughan Elizabeth M EM Hyman David J DJ Naik Aanand D AD Samson Susan L SL Razjouyan Javad J Foreyt John P JP

Journal of general internal medicine 20200722 2

<h4>Background</h4>Many individuals with diabetes live in low- or middle-income settings. Glycemic control is challenging, particularly in resource-limited areas that face numerous healthcare barriers.<h4>Objective</h4>To compare HbA1c outcomes for individuals randomized to TIME, a Telehealth-supported, Integrated care with CHWs (Community Health Workers), and MEdication-access program (intervention) versus usual care (wait-list control).<h4>Design</h4>Randomized clinical trial.<h4>Participants< ...[more]

PMID: 32700217

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Dataset Information

A Telehealth-supported, Integrated care with CHWs, and MEdication-access (TIME) Program for Diabetes Improves HbA1c: a Randomized Clinical Trial.

Background

Objective

Design

Participants

Interventions

Main measures

Key results

Conclusions

Clinical trial

Publications

A Telehealth-supported, Integrated care with CHWs, and MEdication-access (TIME) Program for Diabetes Improves HbA1c: a Randomized Clinical Trial.

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