Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes (ACDC)
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|ClinicalTrials.gov Identifier: NCT01778751|
Recruitment Status : Completed
First Posted : January 29, 2013
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Behavioral: Home Telehealth with Behavioral Education Component||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
No Intervention: Control
Veterans will receive diabetes educational materials and management per their primary provider
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
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.
- Diabetes Control [ Time Frame: Baseline, 3months, 6months ]Hemoglobin A1c as measured at baseline, 3m, 6m
- Diabetes Self Care [ Time Frame: Baseline, 3m, 6m ]Self-Care Inventory-revised as measured at baseline, 3 months, 6 months
- Self-reported Medication Adherence [ Time Frame: Baseline, 3m, 6m ]Change in Self-Reported Medication- Taking Scale as measured at baseline, 3 months, 6 months
- Depressive Symptoms [ Time Frame: Baseline, 3m, 6m ]Change in Patient Health Questionnaire as measured at Baseline, 3 months, 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778751
|United States, North Carolina|
|Durham VA Medical Center, Durham, NC|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Matthew J Crowley, MD||Durham VA Medical Center, Durham, NC|