Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus (PRACTICE-DM)

July 19, 2023 updated by: VA Office of Research and Development

Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus (PRACTICE-DM)

Diabetes generates significant morbidity, mortality, and costs within the Veterans Health Administration (VHA). Veterans with persistently poor diabetes control despite clinic-based care are among the highest-risk diabetes patients in VHA, and contribute disproportionately to VHA's massive burden of diabetes complications and costs. VHA critically needs effective, practical management alternatives for Veterans whose diabetes does not respond to clinic-based management. The proposed study will address this need by leveraging VHA's unique Home Telehealth capacity to deliver comprehensive telemedicine-based management for Veterans with persistently poor diabetes control despite clinic-based care. Because this intensive intervention is delivered using only existing Home Telehealth workforce, infrastructure, and technical resources - which are ubiquitous at VHA centers nationwide - it could represent an effective, practical approach to improving outcomes in Veterans with PPDM, potentially translating to a substantial reduction in VHA's diabetes burden.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate a comprehensive telemedicine intervention for Veterans with persistently poor diabetes control despite clinic-based Veterans Health Administration (VHA) care. Because this approach is designed for delivery via existing Home Telehealth (HT) services, which are ubiquitous throughout VHA, it may represent an effective, practical alternative for Veterans whose diabetes is refractory to clinic-based care.

Although efforts by clinicians and researchers have improved diabetes control across VHA, Veterans with persistent poorly-controlled diabetes mellitus (PPDM) have not benefitted from these advances. The investigators define PPDM as maintenance of a hemoglobin A1c (HbA1c) 8.5% for >1 year, despite receiving clinic-based diabetes care during this period. Veterans meeting this definition - approximately 12% of all Veterans with type 2 diabetes - contribute disproportionately to VHA's burden of diabetes complications and costs.

While clinic-based care is insufficiently effective in PPDM, telemedicine-based management that comprehensively addresses factors underlying poor diabetes control could improve outcomes for these high-risk Veterans. Unfortunately, healthcare systems have rarely integrated comprehensive telemedicine-based care into real-world practice, even for clinic-refractory conditions like PPDM. This gap stems from the fact that comprehensive telemedicine-based diabetes care has not previously been designed for practical delivery under real-world conditions. In order for telemedicine to fulfill its potential as a means to reduce the burden of PPDM, interventions must be developed with an emphasis on feasible delivery through existing workforce, infrastructure, and technical resources, such that effective implementation is eventually achievable. Until then, Veterans with PPDM will be left without alternatives when clinic-based care proves inadequate.

The proposed trial will evaluate Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM), a novel, comprehensive telemedicine intervention for PPDM that is designed for practical delivery within VHA. The Specific Aims of this study are to: 1) determine PRACTICE-DM's effectiveness; 2) evaluate PRACTICE-DM's acceptability and mechanisms of effect using a mixed method process evaluation; and 3) understand costs associated with PRACTICE-DM.

Two hundred Veterans with PPDM from two sites (Durham, North Carolina (NC) and Richmond, Virginia (VA)) will be randomized to receive one of two HT-delivered interventions: 1) PRACTICE-DM, a comprehensive intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression support; or 2) an active control, standard HT care coordination and telemonitoring. Both interventions will be delivered over a 12-month period and all participants will continue to receive usual VHA care.

The primary study outcome will be change in HbA1c from study baseline to 12 months. The secondary outcomes are guided by a theoretical framework, and will include diabetes self-care, diabetes burden, self-efficacy, and depressive symptoms. Qualitative interviews will be conducted with 20 intervention-group Veterans, the HT nurses delivering the intervention, and administrators at each site. Intervention costs will be comprehensively assessed and compared to standard HT care coordination and telemonitoring.

Although VHA is a leader in telemedicine, its telemedicine capabilities are currently underutilized for Veterans with PPDM. These Veterans are refractory to clinic-based care, so contribute disproportionately to diabetes complications and costs. This study will leverage VHA's unique telemedicine infrastructure to deliver comprehensive management designed for PPDM, with the goal of improving outcomes in this high-risk, high cost population. Because the proposed intervention is designed for delivery using existing HT services, it may represent an effective, practical approach to reducing the burden of poor diabetes control across VHA.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705-3875
        • Durham VA Medical Center, Durham, NC
    • Virginia
      • Richmond, Virginia, United States, 23249-0001
        • Hunter Holmes McGuire VA Medical Center, Richmond, VA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Veterans with persistently poorly-controlled type 2 diabetes mellitus defined as the presence of 2 HbA1c values 8.5% during the prior year (none <8.5%) despite 1 or more appointments with a VHA Primary Care Provider (PCP) or Endocrinology during this period.

Exclusion Criteria:

  • age >70
  • life expectancy <5 years, or other comorbidities that would offset the benefits of HbA1c <8.5%
  • inability to communicate by telephone
  • dementia or psychosis
  • active alcohol/substance disorder
  • pregnancy
  • prior hypoglycemic seizure/coma
  • refusal to perform self-monitored blood glucose (SMBG)
  • use of insulin infusion pumps
  • hospitalized for stroke, heart attack or had surgery for blocked arteries in the past 12m
  • receiving kidney dialysis
  • metastatic cancer diagnosis
  • use of a continuous blood glucose monitor (due to HT equipment constraints)
  • primary provider requests patient not participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRACTICE-DM
PRACTICE-DM is a comprehensive telemedicine intervention that bundles telemonitoring, self-management support, diet/activity support, medication management, and depression support - each of which targets a critical factor underlying PPDM - into a single, comprehensive program specifically developed for practical delivery using existing VHA Home Telehealth (HT) workforce, infrastructure, and technical resources.
Other: PRACTICE-DM
Five-component diabetes intervention: 1) telemonitoring; 2) self-management support; 3) diet/activity support; 4) medication management; and 5) depression support.
Active Comparator: Standard VA Home Telehealth
Standard VA HT care coordination and telemonitoring.
Other: Standard VA Home Telehealth
Standard VA HT care coordination and telemonitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 12 months
Laboratory blood test to measure diabetes control
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Distress Scale
Time Frame: 12 months
Measure of diabetes distress and burden using the Diabetes Distress Scale (DDS). 17 items, Scale 1-6. Scoring: Average. Higher score indicates higher distress level.
12 months
Diabetes Self-Management Questionnaire
Time Frame: 12 months
Measure of diabetes self-care. Diabetes Self-Management Questionnaire (DSMQ). 16 items, Scale 0-3. Scoring: Sum and transform to fall between 0-10. Higher score indicates more effective self-care.
12 months
Perceived Competence Scale
Time Frame: 12 months
Measure of diabetes self-efficacy and capacity. Perceived Competence Scale (PCS). 4 items, Scale 1-7. Scoring: average (1-7) Higher score indicates greater confidence.
12 months
Body Mass Index
Time Frame: 6 months
Measure of weight at 6months due to low number of 12month in person visits permitting data collection as a result of coronavirus disease 2019 (COVID-19) restrictions
6 months
Patient Health Questionnaire-8
Time Frame: 12 months
Measure of depressive symptoms, Patient Health Questionnaire depression scale (PHQ8). 8 items, Scale 0-3, Scoring average of responses 0-24. Higher score indicates greater depressive symptoms.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Matthew Crowley, MD, Durham VA Medical Center, Durham, NC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2018

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

April 27, 2018

First Submitted That Met QC Criteria

April 27, 2018

First Posted (Actual)

May 9, 2018

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 16-213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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