Clinical trial NCT01778751: Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes
Official title: Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diabetes
Keywords: Self-Management Support
Depression
Home Telehealth
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-01-29
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Background: Although efforts by VA providers and researchers have improved diabetes care quality for Veterans, individuals with persistent poorly-controlled diabetes mellitus (type 1 or type 2 diabetes with hemoglobin A1c \>9.0% for \> 1 year despite receipt of medical care) have proven refractory to these widespread improvements, and remain at high risk for complications and accrued costs. Prior research has illustrated that medication regimen complexity, suboptimal self-care, and comorbid depressive symptoms interact to perpetuate suboptimal control among individuals with PPDM. Current models of clinic-based diabetes care do not meet these Veterans' needs. Without the implementation of care delivery strategies that target this population's unique barriers to improved diabetes control, these Veterans will continue to be left behind by progress in diabetes management throughout VA, and will remain at high risk for complications and high costs. We propose using existing local Home Telehealth services to implement Advanced Comprehensive Diabetes Care, a patient-centered, evidence-based intervention combining medication management, self-care behavior support, and depressive symptom management to Veterans with PPDM.

Objectives: The specific aims of this RRP are to: 1) evaluate the effectiveness of the Advanced Comprehensive Diabetes Care among Veterans with persistent poorly-controlled diabetes; 2) utilize a mixed method formative evaluation to assess our main implementation strategy, the use of existing Home Telehealth services to administer the intervention; and 3) generate data we will use to refine local intervention implementation and inform the development of an SDP proposal evaluating broader implementation of the Advanced Comprehensive Diabetes Care intervention.

Methods: We propose a pilot Effectiveness-Implementation Hybrid trial to study the Advanced Comprehensive Diabetes Care intervention in Veterans with persistent poorly-controlled diabetes. After baseline evaluation, 50 Veterans will be randomly assigned into intervention (n = 25) or control groups (n = 25). Veterans randomized to the intervention will be enrolled in the Home Telehealth program at Durham VAMC and will receive the study intervention (telehealth-based medication management, self-care behavior support, and depressive symptom management) for 6 months. Intervention-group Veterans with no depression on baseline assessment will not initially receive the depressive symptom management component, but will be monitored for new symptoms throughout the study. Veterans randomized to the control arm will receive diabetes educational materials and management per their primary provider. 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. This RRP will also include a mixed method formative evaluation to qualitatively and quantitatively assess patient-level, provider-level, and organizational barriers and facilitators influencing intervention implementation. Formative evaluation data will be analyzed during the study to consider whether adjustments to the intervention or its implementation may be indicated, and findings will also be used to inform future implementation efforts.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Exclusion criteria will include lack of telephone access or severe hearing/ speech impairment that would limit:

  * 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.).

Primary outcomes:
measure: Diabetes Control
timeFrame: Baseline, 3months, 6months
Secondary outcomes:
measure: Diabetes Self Care
timeFrame: Baseline, 3m, 6m
measure: Self-reported Medication Adherence
timeFrame: Baseline, 3m, 6m
measure: Depressive Symptoms
timeFrame: Baseline, 3m, 6m
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Matthew J Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.