NCT02195063

Brief Summary

This is a survey study that will be given to patients who have been prescribed a topical compound for pain management, wound care or scar care or to patients who have been requested to do a urinary drug test (UDT) by their provider. The initial survey for pain management, wound care, scar care or UDT will be given to the patient by their providers during their office visit.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

3.1 years

First QC Date

July 15, 2014

Last Update Submit

January 27, 2015

Conditions

Keywords

Pain managementScar careWound careUDTUrinary drug testing

Outcome Measures

Primary Outcomes (12)

  • Change in pain survey results from baseline at 30 days

    Survey on pain management

    baseline and 30 days

  • Change in pain survey results from baseline at 60 days

    Survey on pain management

    baseline and 60 days

  • Change in pain survey results from baseline at 90 days

    Survey on pain management

    baseline and 90 days

  • Change in scar care survey results from baseline at 30 days

    Survey on scar care

    baseline and 30 days

  • Change in scar care survey results from baseline at 60 days

    Survey on scar care

    baseline and 60 days

  • Change in scar care survey results from baseline at 90 days

    Survey on scar care

    baseline and 90 days

  • Change in wound care survey results from baseline at 30 days

    Survey on wound care

    baseline and 30 days

  • Change in wound care survey results from baseline at 60 days

    Survey on wound care

    baseline and 60 days

  • Change in wound care survey results from baseline at 90 days

    Survey on wound care

    baseline and 90 days

  • Change in UDT survey results from baseline at 30 days

    Survey on urinary drug testing

    baseline and 30 days

  • Change in UDT survey results from baseline at 60 days

    Survey on urinary drug testing

    baseline and 60 days

  • Change in UDT survey results from baseline at 90 days

    Survey on urinary drug testing

    baseline and 90 days

Secondary Outcomes (12)

  • Change in pain survey results from 30 days at 60 days

    30 days and 60 days

  • Change in pain survey results from 30 days at 90 days

    30 days and 90 days

  • Change in pain survey results from 60 days at 90 days

    60 days and 90 days

  • Length of hospital stay

    at baseline

  • Change in scar care survey results from 30 days at 60 days

    30 days and 60 days

  • +7 more secondary outcomes

Study Arms (4)

Pain management

patients undergoing transdermal treatment for pain

Scar care

patients undergoing transdermal treatment for scars

Wound care

patients undergoing transdermal treatment for wounds

UDT

patients receiving urinary drug tests

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are given a prescription for topical compound for pain, scar care, or wound care, and agree to complete the surveys or Patients who are given a UDT and agree to complete the surveys. Patients will be recruited into the study if their providers prescribe a topical cream for pain, scar care or wound care or if the provider performs a UDT prior to treatment or surgery. The providers will follow their office procedure for UDT. If they perform a UDT and the patient agrees to participate in the survey study, they will have the patient complete the surveys.

You may qualify if:

  • Prescribed a topical cream for pain, scar care, or wound OR Provider preforms urinary drug test

You may not qualify if:

  • Subjects with legally authorized representatives
  • Minors
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blueprint Pathways

Nashville, Tennessee, 37203, United States

RECRUITING

Related Links

MeSH Terms

Conditions

PainCicatrixWounds and InjuriesAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFibrosisPathologic ProcessesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Central Study Contacts

Christina R Cook, PhD

CONTACT

Risa Tyo, PharmD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 21, 2014

Study Start

November 1, 2013

Primary Completion

December 1, 2016

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations