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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01778751
Recruitment Status : Completed
First Posted : January 29, 2013
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Diabetes
Intervention Behavioral: Home Telehealth with Behavioral Education Component
Enrollment 50
Recruitment Details Recruitment occurred December 2013-May 2014 at the Durham VA Medical Center outpatient primary care clinics.
Pre-assignment Details  
Arm/Group Title Control Intervention
Hide Arm/Group Description 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.

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.

Period Title: Overall Study
Started 25 25
Completed 23 23
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             0             2
Transfered care             1             0
Arm/Group Title Control Intervention Total
Hide Arm/Group Description 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.

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 of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
59.5  (9.2) 60.2  (8.4) 59.9  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
0
   0.0%
2
   8.0%
2
   4.0%
Male
25
 100.0%
23
  92.0%
48
  96.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Hispanic or Latino
2
   8.0%
1
   4.0%
3
   6.0%
Not Hispanic or Latino
23
  92.0%
24
  96.0%
47
  94.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
  60.0%
12
  48.0%
27
  54.0%
White
8
  32.0%
13
  52.0%
21
  42.0%
More than one race
1
   4.0%
0
   0.0%
1
   2.0%
Unknown or Not Reported
1
   4.0%
0
   0.0%
1
   2.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Diabetes Control
Hide Description Hemoglobin A1c as measured at baseline, 3m, 6m
Time Frame Baseline, 3months, 6months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated hemoglobin
Baseline 10.7  (1.6) 10.2  (1.4)
3 Months 10.3  (1.8) 9.1  (1.3)
6 months 10.4  (1.6) 9.1  (2.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments Comparison at 3 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-1.7 to -0.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments Comparison at 6 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-2.0 to -0.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Diabetes Self Care
Hide Description Self-Care Inventory-revised as measured at baseline, 3 months, 6 months
Time Frame Baseline, 3m, 6m
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 49.8  (9.6) 52.3  (14.8)
3 months 53.7  (10.9) 58.2  (14.6)
6 months 52.6  (12.6) 61.1  (14.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments Comparison at 3 months, Scale is 0-100 where a higher score is a better outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.303
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
-2.7 to 8.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments Comparison at 6 months, Scale is 0-100 where a higher score is a better outcome.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.7
Confidence Interval (2-Sided) 95%
0.9 to 14.4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Self-reported Medication Adherence
Hide Description Change in Self-Reported Medication- Taking Scale as measured at baseline, 3 months, 6 months
Time Frame Baseline, 3m, 6m
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: participants
Baseline 17 15
3 months 11 9
6 months 9 8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.830
Comments [Not Specified]
Method Generalized estimating equation (GEE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.35 to 2.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments Comparison at 6 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.970
Comments [Not Specified]
Method Generalized Estimating Equation (GEE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.33 to 3.19
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Depressive Symptoms
Hide Description Change in Patient Health Questionnaire as measured at Baseline, 3 months, 6 months
Time Frame Baseline, 3m, 6m
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 7.3  (5.5) 6.9  (5.6)
3 months 6.6  (5.1) 5.5  (6.3)
6 months 5.9  (4.7) 6.7  (6.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments Comparison at 3 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.428
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-3.3 to 1.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments Comparison at 6 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.397
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-1.4 to 3.6
Estimation Comments [Not Specified]
Time Frame Adverse event data were collected at 3 and 6 months for all participants. Participants randomized to the intervention arm were monitored on a more frequent basis during the intervention telephone contacts.
Adverse Event Reporting Description Patients were asked about recent health events and the medical records were reviewed at each follow-up assessment (3&6mths). Participants participating in the intervention were monitored via the home telehealth equipment and intervention telephone contacts.
 
Arm/Group Title Control Intervention
Hide Arm/Group Description 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.

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.

All-Cause Mortality
Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Control Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/25 (16.00%)      3/25 (12.00%)    
Cardiac disorders     
Hospitalization   1/25 (4.00%)  1 1/25 (4.00%)  1
General disorders     
Hospitalization   0/25 (0.00%)  0 1/25 (4.00%)  1
Investigations     
Hypoglycemia Requiring Asssistance   0/25 (0.00%)  0 0/25 (0.00%)  0
Psychiatric disorders     
Hospitalization   1/25 (4.00%)  1 0/25 (0.00%)  0
Psychiatric Disorder  [1]  1/25 (4.00%)  1 0/25 (0.00%)  0
Renal and urinary disorders     
Hospitalization   0/25 (0.00%)  0 1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders     
Hospitalization   1/25 (4.00%)  1 1/25 (4.00%)  1
Outpatient Diagnosis   1/25 (4.00%)  1 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Emergency Room Visit
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Intervention
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/25 (48.00%)      14/25 (56.00%)    
Ear and labyrinth disorders     
Ear infection  [1]  0/25 (0.00%)  0 1/25 (4.00%)  1
Endocrine disorders     
Biopsy  [2]  0/25 (0.00%)  0 1/25 (4.00%)  1
Hyperglycemia  [1]  0/25 (0.00%)  0 1/25 (4.00%)  1
Eye disorders     
Eye pain  [1]  1/25 (4.00%)  1 0/25 (0.00%)  0
General disorders     
Emergency Room Visit  [3]  6/25 (24.00%)  12 7/25 (28.00%)  9
Infections and infestations     
Emergency Room Visit  [4]  1/25 (4.00%)  1 3/25 (12.00%)  3
Investigations     
# Pts with >5 BG Values <70 mg/dL from 1st encounter to end of study  [5]  0/25 (0.00%)  0 3/25 (12.00%)  3
Musculoskeletal and connective tissue disorders     
Emergency Room Visit  [6]  3/25 (12.00%)  3 1/25 (4.00%)  1
Psychiatric disorders     
Psychiatric Disorder  [1]  1/25 (4.00%)  1 0/25 (0.00%)  0
Renal and urinary disorders     
Emergency Room Visit  [7]  1/25 (4.00%)  1 2/25 (8.00%)  2
Respiratory, thoracic and mediastinal disorders     
Emergency Room Visit  [8]  1/25 (4.00%)  1 1/25 (4.00%)  1
Skin and subcutaneous tissue disorders     
Biopsy  [9]  1/25 (4.00%)  2 0/25 (0.00%)  0
cellulitis  [1]  1/25 (4.00%)  1 0/25 (0.00%)  0
Surgical and medical procedures     
Planned Surgery and Proceedures   1/25 (4.00%)  1 2/25 (8.00%)  3
Vascular disorders     
Emergency Room Visit  [10]  1/25 (4.00%)  1 1/25 (4.00%)  1
Indicates events were collected by systematic assessment
[1]
Emergency Room Visit
[2]
Thyroid nodule
[3]
We collected adverse events by organ system and categorized them using the Emergency Room distinction. Affected patients may have visited the ER for a range of conditions (for instance pain, cuts, medication refills, etc)
[4]
We collected adverse events by organ system and categorized them using the Emergency Room distinction. Affected patients may have visited the ER for a range of conditions (for instance coughs, illnesses, etc)
[5]
Telehealth reported data (intervention group only)-
[6]
We collected adverse events by organ system and categorized them using the Emergency Room distinction. Affected patients may have visited the ER for a range of conditions (for instance pain, etc)
[7]
We collected adverse events by organ system and categorized them using the Emergency Room distinction. Affected patients may have visited the ER for a range of conditions (for instance pain associated with stones, etc)
[8]
We collected adverse events by organ system and categorized them using the Emergency Room distinction. Affected patients may have visited the ER for a range of conditions (for instance cough, etc)
[9]
Skin biopsy
[10]
We collected adverse events by organ system and categorized them using the Emergency Room distinction. Affected patients may have visited the ER for a range of conditions (for instance swelling, bleeding, etc)
  • Single-center pilot study
  • Small, male Veteran population with type 2 diabetes
  • Uses VA-specific infrastructure, findings may not translate to other settings.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Matthew J Crowley
Organization: Durham Veterans Affairs Medical Center
Phone: 919-286-6936
EMail: matthew.crowley@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01778751    
Other Study ID Numbers: RRP 12-458
First Submitted: January 18, 2013
First Posted: January 29, 2013
Results First Submitted: November 3, 2015
Results First Posted: January 25, 2016
Last Update Posted: January 25, 2016