- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03834922
Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment (PROMPT)
November 1, 2022 updated by: Prof. Dr. Winfried Meissner
PROMPT Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment A Multicenter, Non-interventional, Prospective Observational Study
PROMPT aims at improving management of acute and chronic pain by identifying a core set of PROMs (patient reported outcome measures) that are predictive indicators of treatment success in clinical practice and controlled trials.
These will not only address pain intensities as well as the functional consequences of pain for individuals but also identify patients at risk of experiencing chronification of acute post-operative pain.
Results will help health care professionals to individualize pain management, and thus improve the quality of life of pain patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In order to reach this objective, a non-interventional prospective data collection aiming at reaching a consensus on a core set of PROMs which reliably predict and/or measure success in acute and chronic pain treatments in real life conditions and identifying predictors for chronification of postoperative pain will be conducted (PROMPT NIT-1).
Aim of the data collection is to evaluate the abilities of certain PROMs in assessing acute post-surgical pain outcomes in daily routine care of patients after four different surgical procedures: (total knee replacement, breast surgery, sternotomy and surgery related to endometriosis), and to validate selected risk factors for chronification prospectively.
Study Type
Observational
Enrollment (Actual)
3322
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Thuringia
-
Jena, Thuringia, Germany, 07747
- Jena University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing one of the following types of surgery: TKA, breast, sternotomy and endometriosis related surgery.
Only female patients will be included in the Breast Surgery and Endometriosis group.
For the other surgeries, there will not be a special preference in the distribution by sex or age for the recruitment.
Description
Inclusion Criteria:
- Patient is of consenting age (>18 years old)
- Elective surgery
- Planned stay in hospital for the surgery
- First contact with the patient before surgery
- Patient agrees to participate
Exclusion Criteria:
- Patient is unable to give consent
- Cognitive impairment
- Questionnaire is not available in a language the patient is fluent in
- Patient not willing to answer the follow-up questionnaire
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Total knee arthroplasty
Patients undergoing total knee arthroplasty
|
No intervention.
It's a prospective data collection.
|
Sternotomy
Patients undergoing sternotomy
|
No intervention.
It's a prospective data collection.
|
Breast
Patients undergoing breast surgery
|
No intervention.
It's a prospective data collection.
|
Endometriosis
Patients undergoing endometriosis-related surgery
|
No intervention.
It's a prospective data collection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WP 2 - Acute pain: Sensitivity to change
Time Frame: 2019 - 2022
|
For WP2, the primary endpoint will be pain intensity at day 3 (NRS Scale from 0 to 10, 0 being no pain, 10 being worst pain imaginable).
This primary endpoint (PROMs) will be used to assess sensitivity to change from POD3 to POD1.
|
2019 - 2022
|
WP 3 - Chronification of pain: Incidence of chronic post-surgical pain (CPSP)
Time Frame: 2019 - 2022
|
For WP3, the primary end point will be the incidence of moderate to severe CPSP (Numeric rating scale ≥ 3/10) at 6 months using the average pain on the Brief Pain Inventory Questionnaire.
|
2019 - 2022
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective physical activity and sleep, measured with Actigraph devices
Time Frame: 01/2020 to 12/2021
|
Correlation of physical activity data (average no. of steps of days 5 to 7) with PRO "physical function" on day 7;
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01/2020 to 12/2021
|
Association between other POD7 PROMs and activity/sleep
Time Frame: 01/2020 to 12/2021
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Association between other POD7 PROMs and activity/sleep
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01/2020 to 12/2021
|
Association between peri-operative processes and activity/sleep
Time Frame: 01/2020 to 12/2021
|
Association between peri-operative processes and activity/sleep
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01/2020 to 12/2021
|
Is decreased activity a predictor for chronic postsurgical pain?
Time Frame: 01/2020 to 12/2021
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Is decreased activity a predictor for chronic postsurgical pain on POM6?
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01/2020 to 12/2021
|
Do activity trajectories since surgery parallel trajectories of other outcomes?
Time Frame: 01/2020 to 12/2021
|
Do activity trajectories since surgery parallel trajectories of other outcomes?
|
01/2020 to 12/2021
|
Correlation of activity difference between POD5-7 and preop with POD7 oucomes
Time Frame: 01/2020 to 12/2021
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Correlation of activity difference between POD5-7 and preop with POD7 oucomes
|
01/2020 to 12/2021
|
Association between ambient light intensity and outcomes on POD7
Time Frame: 01/2020 to 12/2021
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Association between ambient light intensity and outcomes on POD7
|
01/2020 to 12/2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Winfried Meissner, Prof., Jena University Hospital
- Study Chair: Hiltrud Liedgens, Dr., Grünenthal GmbH
- Principal Investigator: Esther Pogatzki-Zahn, Prof., University Hospital Münster
- Principal Investigator: Dominique Fletcher, Prof., Hospital Ambroise Paré Paris
- Principal Investigator: Shaloo Pandhi, Novartis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2019
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
February 7, 2019
First Submitted That Met QC Criteria
February 7, 2019
First Posted (Actual)
February 8, 2019
Study Record Updates
Last Update Posted (Actual)
November 2, 2022
Last Update Submitted That Met QC Criteria
November 1, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 777500-IMI-PainCare PROMPT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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