Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus

NCT03520413 | Completed Results DMC

• 1 other identifier: IIR 16-213
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Telemedicine

Keywords

Complex Care; Outcomes; Telemedicine; Rural Health; Diabetes

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  Laboratory blood test to measure diabetes control

  12 months

Secondary Outcomes (5)

• Diabetes Distress Scale

  12 months

• Diabetes Self-Management Questionnaire

  12 months

• Perceived Competence Scale

  12 months

• Body Mass Index

  6 months

• Patient Health Questionnaire-8

  12 months

Study Arms (2)

PRACTICE-DM

EXPERIMENTAL

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

Standard VA Home Telehealth

ACTIVE COMPARATOR

Standard VA HT care coordination and telemonitoring.

Other: Standard VA Home Telehealth

Interventions

PRACTICE-DM OTHER

Five-component diabetes intervention: 1) telemonitoring; 2) self-management support; 3) diet/activity support; 4) medication management; and 5) depression support.

PRACTICE-DM

Standard VA Home Telehealth OTHER

Standard VA HT care coordination and telemonitoring.

Standard VA Home Telehealth

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001, United States

Location

Related Publications (4)

• Kobe EA, Edelman D, Tarkington PE, Bosworth HB, Maciejewski ML, Steinhauser K, Jeffreys AS, Coffman CJ, Smith VA, Strawbridge EM, Szabo ST, Desai S, Garrett MP, Wilmot TC, Marcano TJ, Overby DL, Tisdale GA, Durkee M, Bullard S, Dar MS, Mundy AC, Hiner J, Fredrickson SK, Majette Elliott NT, Howard T, Jeter DH, Danus S, Crowley MJ. Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial. Contemp Clin Trials. 2020 Nov;98:106157. doi: 10.1016/j.cct.2020.106157. Epub 2020 Sep 21.

  PMID: 32971277 RESULT

• Lewinski AA, Crowley MJ, Miller C, Bosworth HB, Jackson GL, Steinhauser K, White-Clark C, McCant F, Zullig LL. Applied Rapid Qualitative Analysis to Develop a Contextually Appropriate Intervention and Increase the Likelihood of Uptake. Med Care. 2021 Jun 1;59(Suppl 3):S242-S251. doi: 10.1097/MLR.0000000000001553.

  PMID: 33976073 RESULT

• Crowley MJ, Tarkington PE, Bosworth HB, Jeffreys AS, Coffman CJ, Maciejewski ML, Steinhauser K, Smith VA, Dar MS, Fredrickson SK, Mundy AC, Strawbridge EM, Marcano TJ, Overby DL, Majette Elliott NT, Danus S, Edelman D. Effect of a Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial. JAMA Intern Med. 2022 Sep 1;182(9):943-952. doi: 10.1001/jamainternmed.2022.2947.

  PMID: 35877092 RESULT

• Duffy RA, Jeffreys AS, Coffman CJ, Alexopoulos AS, Tarkington PE, Bosworth H, Edelman D, Crowley MJ. Evaluating Therapeutic Inertia in Two Telehealth Interventions for Type 2 Diabetes: Secondary Analyses of a Randomized Trial. Telemed J E Health. 2024 Jun;30(6):e1790-e1797. doi: 10.1089/tmj.2023.0453. Epub 2024 Feb 19.

  PMID: 38377570 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Matthew Crowley, MD
• Organization: Durham Veterans Affairs Medical Center

matthew.crowley@va.gov

919-286-0411

Study Officials

• Matthew Crowley, MD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because participants will receive information on both study arms during the consent process, we will not attempt to blind participants to randomization assignment. However, in order to assure blinding of the staff that manage outcome data collection, randomization (including participant notification of group assignment by phone) will be managed by the project coordinator.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: VA Home Telehealth (HT) nurses will deliver the 5 intervention components during telephone encounters. The standard encounter frequency will be every two weeks, but may be extended to every 4 weeks for participants achieving their HbA1c goal. Should Veterans relapse while receiving the lower encounter frequency, HT will return to every-two-week encounters until the next HbA1c assessment. The 5 intervention components are: Telemonitoring, Self-management support, Diet/activity support, Medication management, \& Depression support

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 9, 2018
• Study Start: December 21, 2018
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: July 27, 2023
• Results First Posted: January 26, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)