ClinicalTrials.gov
ClinicalTrials.gov Menu

Diabetes Telemedicine Consultation: A Systems Improvement Intervention

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: NCT00119041
Recruitment Status : Completed
First Posted : July 12, 2005
Results First Posted : May 12, 2015
Last Update Posted : June 15, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions Diabetes Mellitus Type 2
Diabetes Mellitus, Type 1
Primary Care Provider
Interventions Behavioral: The Diabetes Treatment Satisfaction Questionnaire
Behavioral: Diabetes Empowerment Scale
Behavioral: CBOC's undergo half-day joint-clinics via teleconference
Enrollment 304
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telemedicine CBOC Control CBOC Provider Interview
Hide Arm/Group Description

Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.

The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.

Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.

CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.

The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education. Qualitative interviews with providers
Period Title: Overall Study
Started 199 83 22
Completed 199 83 22
Not Completed 0 0 0
Arm/Group Title Telemedicine CBOC Control CBOC Provider Interview Total
Hide Arm/Group Description

Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.

The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.

Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.

CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.

We did not collect gender and age related data.

The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education. Qualitative interviews with providers Total of all reporting groups
Overall Number of Baseline Participants 199 83 22 304
Hide Baseline Analysis Population Description
Cohort I will consist of high-risk patients referred to a specialist during the 9-month active intervention and enrollment phase.Cohort II will consist of all other patients with diabetes (i.e., all non-Cohort I patients). We didn't collect gender or the complete age data. Qualitative interviews with providers
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
18 years and older Number Analyzed 199 participants 83 participants 22 participants 304 participants
199 83 22 304
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 199 participants 83 participants 22 participants 304 participants
NA [1]  NA [1]  NA [1]  NA [2] 
[1]
Gender was not collected for this study
[2]
Total not calculated because data are not available (NA) in one or more arms.
1.Primary Outcome
Title A1c
Hide Description Hemoglobin A1c is a measure of glycemic control
Time Frame baseline and 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telemedicine Control
Hide Arm/Group Description:
Intervention group
non intervention group
Overall Number of Participants Analyzed 199 83
Mean (Full Range)
Unit of Measure: percentage of Hb that is glycosylated
baseline
10.1
(6.4 to 14.9)
9.32
(5.3 to 15.9)
18 months
8.82
(5 to 14)
8.36
(6 to 13)
2.Secondary Outcome
Title Patient Satisfaction
Hide Description Diabetes Treatment Satisfaction Questionnaire (DTSQ) consists of 6 questions and ranges from 0-6. The following aspects of current treatment included were convenience, flexibility, understanding and continuing present form of treatment. The total range of the DTSQ is the sum of the 6 individual questions scores (i.e. 0-36) Higher scores represent greater satisfaction/convenience.
Time Frame Base line and at18 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number subjects was determined on the size of the CBOC.
Arm/Group Title Telemedicine CBOC Control CBOC
Hide Arm/Group Description:

Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.

The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference.

The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.

Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.

CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.

Received the questionnaires by mail and had no intervention of diabetes teleconference
Overall Number of Participants Analyzed 199 83
Mean (Full Range)
Unit of Measure: units on a scale
baseline
24.33
(0 to 36)
23.29
(6 to 36)
18 months
23.55
(8 to 36)
23.9
(8 to 36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telemedicine CBOC, Control CBOC
Comments Comparisons were made between the intervention and control groups at baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.153
Comments Threshold for statistical significance was p<0.025 using Bonferroni correction for 2 statistical tests.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telemedicine CBOC, Control CBOC
Comments Comparisons were made between the intervention and control groups at 18 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.25
Comments Threshold for statistical significance was p<0.025 using Bonferroni correction for 2 statistical tests.
Method t-test, 2 sided
Comments Threshold for statistical significance was p<0.025 using Bonferroni correction for 2 statistical tests.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telemedicine CBOC Control CBOC Provider Interviews
Hide Arm/Group Description

Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.

The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference.

The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.

Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.

CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.

The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education. Qualitative interviews with providers.
All-Cause Mortality
Telemedicine CBOC Control CBOC Provider Interviews
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telemedicine CBOC Control CBOC Provider Interviews
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/199 (0.00%)   0/83 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Telemedicine CBOC Control CBOC Provider Interviews
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/199 (0.00%)   0/83 (0.00%)   0/22 (0.00%) 
A potential factor jeopardizing both internal and external validity relates to fact that the consultation process may be very dependent on the particular individuals involved.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: David C. Aron, MD, MS
Organization: Louis Stokes VA Medical Center
Phone: (216) 791-2300 ext 5702
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00119041     History of Changes
Other Study ID Numbers: IIR 03-254
First Submitted: July 1, 2005
First Posted: July 12, 2005
Results First Submitted: July 2, 2014
Results First Posted: May 12, 2015
Last Update Posted: June 15, 2015