PainNCT02195063
Survey Study for Pain Management, Wound Care, Scar Care or UDT
An observational study of Pain and Scars, run by Rahm Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Prescribed a topical cream for pain, scar care, or wound OR Provider preforms urinary drug test
Who cannot join
- Subjects with legally authorized representatives
- Minors
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Blueprint Pathways
Nashville, Tennessee, 37203
Christina R Cook, PhD, 615-712-9574, ccook@blueprintpathways.com
Risa Tyo, PharmD, 615-712-9574, rtyo@datumcro.com
About this study
Official title: Survey of 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.
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.
Read the detailed description
We have designed 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.
Follow-up surveys will be given at 30, 60, and 90 days. These surveys will be collected by e-mail or follow-up calls from Datum Research, LLC, contract research organization.
Data collection for this study will be derived through the 4 patient surveys (initial, 30 day, 60 day, and 90 day) and the prescription written by the provider.
The survey study will enroll patients until December 31, 2014, or until sufficient numbers have been achieved.
Rahm Foundation will continue the study until:
- Sufficient information has accumulated to meet the scientific objectives of the Study (i.e. numeric targets or effect size)
- The feasibility of collecting sufficient information diminishes to unacceptable levels, poor enrollment, loss to follow-up and/or
- Other methods of gathering appropriate information become achievable or are deemed preferable.
Datum Research will need to have access to the prescription to see what compound was prescribed.
- Conditions
- Pain, Scars, Wounds, Urinary Drug Testing
- Keywords
- Pain management, Scar care, Wound care, UDT, Urinary drug testing
- Medical subject headings
- Pain, Cicatrix, Wounds and Injuries, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain survey results from baseline at 30 days
Survey on pain management
Measured: baseline and 30 days
Change in pain survey results from baseline at 60 days
Survey on pain management
Measured: baseline and 60 days
Change in pain survey results from baseline at 90 days
Survey on pain management
Measured: baseline and 90 days
Change in scar care survey results from baseline at 30 days
Survey on scar care
Measured: baseline and 30 days
Change in scar care survey results from baseline at 60 days
Survey on scar care
Measured: baseline and 60 days
Change in scar care survey results from baseline at 90 days
Survey on scar care
Measured: baseline and 90 days
Change in wound care survey results from baseline at 30 days
Survey on wound care
Measured: baseline and 30 days
Change in wound care survey results from baseline at 60 days
Survey on wound care
Measured: baseline and 60 days
Change in wound care survey results from baseline at 90 days
Survey on wound care
Measured: baseline and 90 days
Change in UDT survey results from baseline at 30 days
Survey on urinary drug testing
Measured: baseline and 30 days
Change in UDT survey results from baseline at 60 days
Survey on urinary drug testing
Measured: baseline and 60 days
Change in UDT survey results from baseline at 90 days
Survey on urinary drug testing
Measured: baseline and 90 days
Secondary outcomes (12)
Change in pain survey results from 30 days at 60 days
Survey on pain management
Measured: 30 days and 60 days
Change in pain survey results from 30 days at 90 days
Survey on pain management
Measured: 30 days and 90 days
Change in pain survey results from 60 days at 90 days
Survey on pain management
Measured: 60 days and 90 days
Length of hospital stay
if applicable
Measured: at baseline
Change in scar care survey results from 30 days at 60 days
Survey on scar care
Measured: 30 days and 60 days
Change in scar care survey results from 30 days at 90 days
Survey on scar care
Measured: 30 days and 90 days
Change in scar care survey results from 60 days at 90 days
Survey on scar care
Measured: 60 days and 90 days
Change in wound care survey results from 30 days at 60 days
Survey on wound care
Measured: 30 days and 60 days
Change in wound care survey results from 30 days at 90 days
Survey on wound care
Measured: 30 days and 90 days
Change in UDT survey results from 60 days at 90 days
Survey on urinary drug testing
Measured: 60 days and 90 days
Change in UDT survey results from 30 days at 60 days
Survey on urinary drug testing
Measured: 30 days and 60 days
Change in UDT survey results from 30 days at 90 days
Survey on urinary drug testing
Measured: 30 days and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rahm Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Datum Research, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195063
- Sponsor's protocol ID
- RAHM 1001
- Status last verified
- Jan 2015
- First submitted
- 15 Jul 2014
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of 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.
- ClinicalTrials.gov ID
- NCT02195063
- Acronym / sponsor ID
- RAHM 1001
- Conditions
- Pain, Scars, Wounds, Urinary Drug Testing
- Keywords
- Pain management, Scar care, Wound care, UDT, Urinary drug testing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Rahm FoundationUniversity, hospital or other
- Collaborators
- Datum Research, LLC
- Study start
- Nov 2013
- Primary completion
- Dec 2016 (estimated)
- First posted
- 21 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We have designed 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.
Follow-up surveys will be given at 30, 60, and 90 days. These surveys will be collected by e-mail or follow-up calls from Datum Research, LLC, contract research organization.
Data collection for this study will be derived through the 4 patient surveys (initial, 30 day, 60 day, and 90 day) and the prescription written by the provider.
The survey study will enroll patients until December 31, 2014, or until sufficient numbers have been achieved.
Rahm Foundation will continue the study until:
- Sufficient information has accumulated to meet the scientific objectives of the Study (i.e. numeric targets or effect size)
- The feasibility of collecting sufficient information diminishes to unacceptable levels, poor enrollment, loss to follow-up and/or
- Other methods of gathering appropriate information become achievable or are deemed preferable.
Datum Research will need to have access to the prescription to see what compound was prescribed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Prescribed a topical cream for pain, scar care, or wound OR Provider preforms urinary drug test
Key exclusion criteria (3 listed)
- Subjects with legally authorized representatives
- Minors
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in pain survey results from baseline at 30 days
Time frame: baseline and 30 days
Survey on pain management
Change in pain survey results from baseline at 60 days
Time frame: baseline and 60 days
Survey on pain management
Change in pain survey results from baseline at 90 days
Time frame: baseline and 90 days
Survey on pain management
Change in scar care survey results from baseline at 30 days
Time frame: baseline and 30 days
Survey on scar care
Change in scar care survey results from baseline at 60 days
Time frame: baseline and 60 days
Survey on scar care
Change in scar care survey results from baseline at 90 days
Time frame: baseline and 90 days
Survey on scar care
Change in wound care survey results from baseline at 30 days
Time frame: baseline and 30 days
Survey on wound care
Change in wound care survey results from baseline at 60 days
Time frame: baseline and 60 days
Survey on wound care
Change in wound care survey results from baseline at 90 days
Time frame: baseline and 90 days
Survey on wound care
Change in UDT survey results from baseline at 30 days
Time frame: baseline and 30 days
Survey on urinary drug testing
Change in UDT survey results from baseline at 60 days
Time frame: baseline and 60 days
Survey on urinary drug testing
Change in UDT survey results from baseline at 90 days
Time frame: baseline and 90 days
Survey on urinary drug testing
12 secondary outcomes
Change in pain survey results from 30 days at 60 days
Time frame: 30 days and 60 days
Change in pain survey results from 30 days at 90 days
Time frame: 30 days and 90 days
Change in pain survey results from 60 days at 90 days
Time frame: 60 days and 90 days
Length of hospital stay
Time frame: at baseline
Change in scar care survey results from 30 days at 60 days
Time frame: 30 days and 60 days
Change in scar care survey results from 30 days at 90 days
Time frame: 30 days and 90 days
Change in scar care survey results from 60 days at 90 days
Time frame: 60 days and 90 days
Change in wound care survey results from 30 days at 60 days
Time frame: 30 days and 60 days
Change in wound care survey results from 30 days at 90 days
Time frame: 30 days and 90 days
Change in UDT survey results from 60 days at 90 days
Time frame: 60 days and 90 days
Change in UDT survey results from 30 days at 60 days
Time frame: 30 days and 60 days
Change in UDT survey results from 30 days at 90 days
Time frame: 30 days and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
- Blueprint PathwaysLink provided by the sponsor.
- The Rahm FoundationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Scars, run by Rahm Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina R Cook, PhD (615-712-9574, ccook@blueprintpathways.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain survey results from baseline at 30 days (time frame: baseline and 30 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015.