Diabetes Telemedicine Consultation: A Systems Improvement Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00119041
First received: July 1, 2005
Last updated: April 23, 2015
Last verified: April 2015
Results First Received: July 2, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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

  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
No text entered.

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
Telemedicine CBOC

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.

Control CBOC The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
Provider Interview Qualitative interviews with providers

Participant Flow:   Overall Study
    Telemedicine CBOC     Control CBOC     Provider Interview  
STARTED     199     83     22  
COMPLETED     199     83     22  
NOT COMPLETED     0     0     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.

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


Reporting Groups
  Description
Telemedicine CBOC

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.

Control CBOC The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
Provider Interview Qualitative interviews with providers
Total Total of all reporting groups

Baseline Measures
    Telemedicine CBOC     Control CBOC     Provider Interview     Total  
Number of Participants  
[units: participants]
  199     83     22     304  
Age, Customized  
[units: participants]
       
18 years and older     199     83     22     304  
Gender, Customized  
[units: participants]
  NA [2]   NA [2]   NA [2]   NA [1]
[1] Total not calculated because data are not available (NA) in one or more arms.
[2] Gender was not collected for this study



  Outcome Measures
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1.  Primary:   A1c   [ Time Frame: baseline and 18 months ]

2.  Secondary:   Patient Satisfaction   [ Time Frame: Base line and at18 months. ]


  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
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.


  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: David C. Aron, MD, MS
Organization: Louis Stokes VA Medical Center
phone: (216) 791-2300 ext 5702
e-mail: david.aron@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00119041     History of Changes
Other Study ID Numbers: IIR 03-254
Study First Received: July 1, 2005
Results First Received: July 2, 2014
Last Updated: April 23, 2015
Health Authority: United States: Federal Government