Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes

NCT01778751 | Completed Early Phase 1 Results

• 1 other identifier: RRP 12-458
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine whether Home Telehealth-based implementation of an evidence-based intervention targeting Veterans with persistent poorly-controlled diabetes can improve hemoglobin A1c, patient self-management, and comorbid depressive symptoms in this high-risk, high-cost population. If effective, this intervention (Advanced Comprehensive Diabetes Care) offers a feasible, sustainable, and generalizable approach to managing Veterans with persistent poorly-controlled diabetes, which can be implemented using only existing Home Telehealth services.

Conditions

Diabetes

Keywords

Self-Management Support; Depression; Home Telehealth

Outcome Measures

Primary Outcomes (1)

• Diabetes Control

  Hemoglobin A1c as measured at baseline, 3m, 6m

  Baseline, 3months, 6months

Secondary Outcomes (3)

• Diabetes Self Care

  Baseline, 3m, 6m

• Self-reported Medication Adherence

  Baseline, 3m, 6m

• Depressive Symptoms

  Baseline, 3m, 6m

Study Arms (2)

Control

NO INTERVENTION

Veterans will receive diabetes educational materials and management per their primary provider

Intervention

EXPERIMENTAL

Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 \< 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.

Behavioral: Home Telehealth with Behavioral Education Component

Interventions

Home Telehealth with Behavioral Education Component BEHAVIORAL

The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans with type 2 diabetes managed for \> 1 year at an eligible site (Durham, Raleigh, Greenville, or Morehead City) will be eligible for enrollment.
• We will identify Veterans with PPDM (defined as the presence of at least 2 A1c values of \> 9.0% during the past year with no readings of \< 9.0% despite ongoing medical care) by reviewing electronic medical records and soliciting referrals from primary physicians.

You may not qualify if:

• telephone interaction
• metastatic cancer
• active psychosis documented in medical record
• active alcohol or substance abuse
• diagnosis of dementia
• known pregnancy (patients becoming pregnant during the study will be withdrawn and referred to appropriate services)
• documented seizure history
• documented history of severe complications of hypoglycemia (such as coma or seizure)
• documented refusal or inability to perform self-monitoring of blood glucose
• ongoing use of warfarin with prior history of major bleeding event
• Due to challenges with dose adjustment by phone, Veterans on continuous subcutaneous insulin infusion (insulin pumps) will not be eligible for this study.
• Due to challenges with regulations regarding testing supplies pts will need to be taking insulin (a few patients had enrolled prior to this change.).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Crowley MJ, Edelman D, McAndrew AT, Kistler S, Danus S, Webb JA, Zanga J, Sanders LL, Coffman CJ, Jackson GL, Bosworth HB. Practical Telemedicine for Veterans with Persistently Poor Diabetes Control: A Randomized Pilot Trial. Telemed J E Health. 2016 May;22(5):376-84. doi: 10.1089/tmj.2015.0145. Epub 2015 Nov 5.

  PMID: 26540163 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Depression

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Limitations and Caveats

* Single-center pilot study * Small, male Veteran population with type 2 diabetes * Uses VA-specific infrastructure, findings may not translate to other settings.

Results Point of Contact

• Title: Dr Matthew J Crowley
• Organization: Durham Veterans Affairs Medical Center

matthew.crowley@va.gov

919-286-6936

Study Officials

• Matthew J Crowley, MD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: January 29, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 25, 2016
• Results First Posted: January 25, 2016

Record last verified: 2015-12

Locations

US (1)