NCT00488293

Brief Summary

This study compares store and forward teledermatology with the conventional clinic-based consult process. Our primary objective is to determine whether the mean change in quality of life, as rated by the subscale scores and composite score on the Skindex-16 differs between the store and forward and conventional care modalities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
392

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

December 15, 2014

Completed
Last Updated

June 8, 2015

Status Verified

May 1, 2015

Enrollment Period

2.3 years

First QC Date

June 18, 2007

Results QC Date

November 3, 2014

Last Update Submit

May 11, 2015

Conditions

Skin DiseasesTelemedicineQuality of Life

Keywords

TelemedicineSkin diseasesDermatologyQuality of lifeEconomics

Outcome Measures

Primary Outcomes (8)

  • Skindex-16 Change Scores Between Baseline to Month 9 - Composite Score

    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

    Baseline to Month 9

  • Skindex-16 Change Scores Baseline to Month 3 - Composite Score

    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

    Baseline to Month 3

  • Skindex-16 Change Scores Baseline to Month 9 - Symptoms Score

    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

    Baseline to Month 9

  • Skindex-16 Changes Scores Baseline to Month 3 - Symptoms Score

    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

    Baseline to Month 3

  • Skindex-16 Change Scores Between Baseline and Month 9 - Emotions Score

    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

    Baseline to Month 9

  • Skindex-16 Change Scores Between Baseline to Month 3 - Emotions Score

    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

    Baseline to Month 3

  • Skindex-16 Change Scores Between Baseline and Month 9 - Functioning Scores

    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

    Baseline to Month 9

  • Skindex-16 Change Scores Between Baseline and Month 3 - Functioning Score

    Skindex-16 Change Scores. Skindex-16 is a quality of life measure that assesses "bother." It includes the domains of symptoms, emotions, and functioning. A composite (total) score can also be calculated. The range of scores are 0 (never bothered) to 100 (always bothered) for subscale and composite scores. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.

    Baseline to Month 3

Secondary Outcomes (2)

  • Clinical Course Rating Between Baseline and Month 9

    Baseline to Month 9

  • Clinical Course Rating Between Baseline and First Clinic Visit

    Baseline to First Clinic Visit

Study Arms (2)

Arm 1

EXPERIMENTAL

Store and forward teledermatology consult process

Procedure: Store and forward teledermatology

Arm 2

NO INTERVENTION

Conventional consult process

Interventions

Store and forward teledermatologyPROCEDURE

Standard electronic consult, standardized history, and image set

Also known as: Teledermatology
Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a single non-emergent skin condition being referred to a VA Dermatology Clinic
  • Must be a veteran at the study site

You may not qualify if:

  • Full body examination requested
  • Unable to read or speak English
  • Emergent skin condition
  • Pending dermatology appointment within 9 months
  • Previous enrollment in the study
  • Impending move from the area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Harry S. Truman Memorial, Columbia, MO

Columbia, Missouri, 65201-5297, United States

Location

Related Publications (3)

  • Whited JD, Warshaw EM, Edison KE, Kapur K, Thottapurathu L, Raju S, Cook B, Engasser H, Pullen S, Parks P, Sindowski T, Motyka D, Brown R, Moritz TE, Datta SK, Chren MM, Marty L, Reda DJ. Effect of store and forward teledermatology on quality of life: a randomized controlled trial. JAMA Dermatol. 2013 May;149(5):584-91. doi: 10.1001/2013.jamadermatol.380.

    PMID: 23426111BACKGROUND

  • Whited JD, Warshaw EM, Kapur K, Edison KE, Thottapurathu L, Raju S, Cook B, Engasser H, Pullen S, Moritz TE, Datta SK, Marty L, Foman NA, Suwattee P, Ward DS, Reda DJ. Clinical course outcomes for store and forward teledermatology versus conventional consultation: a randomized trial. J Telemed Telecare. 2013 Jun;19(4):197-204. doi: 10.1177/1357633x13487116. Epub 2013 May 23.

    PMID: 23666440RESULT

  • Datta SK, Warshaw EM, Edison KE, Kapur K, Thottapurathu L, Moritz TE, Reda DJ, Whited JD. Cost and Utility Analysis of a Store-and-Forward Teledermatology Referral System: A Randomized Clinical Trial. JAMA Dermatol. 2015 Dec 1;151(12):1323-1329. doi: 10.1001/jamadermatol.2015.2362.

    PMID: 26375589DERIVED

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Results Point of Contact

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

Study Officials

  • John D. Whited, MD MHS

    Harry S. Truman Memorial, Columbia, MO

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2007

First Posted

June 20, 2007

Study Start

November 1, 2008

Primary Completion

February 1, 2011

Study Completion

June 1, 2011

Last Updated

June 8, 2015

Results First Posted

December 15, 2014

Record last verified: 2015-05

Locations

US(2)