Impact of Teledermatology on Health Services Outcomes in the Department of Veterans Affairs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00488293
First received: June 18, 2007
Last updated: May 11, 2015
Last verified: May 2015
Results First Received: November 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Skin Diseases
Telemedicine
Quality of Life
Intervention: Procedure: Store and forward teledermatology

  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 between 2008 and 2011.

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
Teledermatology Referrals

Store and forward teledermatology consult process

Store and forward teledermatology: Standard electronic consult, standardized history, and image set

Conventional Referrals

Conventional consult process

Conventional consult process: Standard electronic consult


Participant Flow:   Overall Study
    Teledermatology Referrals     Conventional Referrals  
STARTED     196     196  
COMPLETED     160     166  
NOT COMPLETED     36     30  
Lost to Follow-up                 28                 25  
Withdrawal by Subject                 5                 3  
Death                 2                 1  
Misrandomization/Other Unspecified                 1                 1  



  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.
One patient assigned to teledermatology was misrandomized and not included in the analysis.

Reporting Groups
  Description
Teledermatology Referrals

Store and forward teledermatology consult process

Store and forward teledermatology: Standard electronic consult, standardized history, and image set

Conventional Referrals

Conventional consult process

Conventional consult process: Standard electronic consult

Total Total of all reporting groups

Baseline Measures
    Teledermatology Referrals     Conventional Referrals     Total  
Number of Participants  
[units: participants]
  195     196     391  
Age  
[units: years]
Mean (Standard Deviation)
  61.7  (14.9)     62.9  (13.9)     62.3  (14.4)  
Gender  
[units: participants]
     
Female     5     4     9  
Male     190     192     382  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     2     2  
Not Hispanic or Latino     193     191     384  
Unknown or Not Reported     2     3     5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score   [ Time Frame: Baseline to Month 9 ]

2.  Primary:   Skindex-16 Change Scores Baseline to Month 3 - Composite Score   [ Time Frame: Baseline to Month 3 ]

3.  Primary:   Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score   [ Time Frame: Baseline to Month 9 ]

4.  Primary:   Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score   [ Time Frame: Baseline to Month 3 ]

5.  Primary:   Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score   [ Time Frame: Baseline to Month 9 ]

6.  Primary:   Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score   [ Time Frame: Baseline to Month 3 ]

7.  Primary:   Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores   [ Time Frame: Baseline to Month 9 ]

8.  Primary:   Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score   [ Time Frame: Baseline to Month 3 ]

9.  Secondary:   Clinical Course Rating Between Baseline and Month 9   [ Time Frame: Baseline to Month 9 ]

10.  Secondary:   Clinical Course Rating Between Baseline and First Clinic Visit   [ Time Frame: Baseline to First Clinic Visit ]


  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
No text entered.


  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: John D. Whited, MD, MHS
Organization: Department of Veterans Affairs
phone: 919-286-6926
e-mail: john.whited@va.gov


Publications of Results:
Other Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00488293     History of Changes
Other Study ID Numbers: IIR 05-278
Study First Received: June 18, 2007
Results First Received: November 3, 2014
Last Updated: May 11, 2015
Health Authority: United States: Federal Government