Advanced Comprehensive Diabetes Care for Veterans With Poorly-Controlled Diabetes (ACDC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01778751
First received: January 18, 2013
Last updated: December 16, 2015
Last verified: December 2015
Results First Received: November 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Diabetes
Intervention: Behavioral: Home Telehealth with Behavioral Education Component

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred December 2013-May 2014 at the Durham VA Medical Center outpatient primary care clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Veterans will receive diabetes educational materials and management per their primary provider
Intervention

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.

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.


Participant Flow:   Overall Study
    Control     Intervention  
STARTED     25     25  
COMPLETED     23     23  
NOT COMPLETED     2     2  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 0                 2  
Transfered care                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Veterans will receive diabetes educational materials and management per their primary provider
Intervention

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.

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.

Total Total of all reporting groups

Baseline Measures
    Control     Intervention     Total  
Number of Participants  
[units: participants]
  25     25     50  
Age  
[units: years]
Mean (Standard Deviation)
  59.5  (9.2)     60.2  (8.4)     59.9  (8.7)  
Gender  
[units: participants]
     
Female     0     2     2  
Male     25     23     48  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     2     1     3  
Not Hispanic or Latino     23     24     47  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     15     12     27  
White     8     13     21  
More than one race     1     0     1  
Unknown or Not Reported     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     25     25     50  



  Outcome Measures
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1.  Primary:   Diabetes Control   [ Time Frame: Baseline, 3months, 6months ]

2.  Secondary:   Diabetes Self Care   [ Time Frame: Baseline, 3m, 6m ]

3.  Secondary:   Self-reported Medication Adherence   [ Time Frame: Baseline, 3m, 6m ]

4.  Secondary:   Depressive Symptoms   [ Time Frame: Baseline, 3m, 6m ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  • Single-center pilot study
  • Small, male Veteran population with type 2 diabetes
  • Uses VA-specific infrastructure, findings may not translate to other settings.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Matthew J Crowley
Organization: Durham Veterans Affairs Medical Center
phone: 919-286-6936
e-mail: matthew.crowley@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01778751     History of Changes
Other Study ID Numbers: RRP 12-458
Study First Received: January 18, 2013
Results First Received: November 3, 2015
Last Updated: December 16, 2015
Health Authority: United States: Federal Government