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NCT02873429 · ClinicalTrials.gov registry record
Measuring the Context of Healing in Chronic Pain Treatment
A clinical trial, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 218
- Enrollment target
NCT02873429: Completed study, sponsored by University of Pittsburgh.
NCT02873429 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 218 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02873429 has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 218 participants
- Enrollment target
Study Summary
This project focuses on whether nonspecific factors as well as patient characteristics contribute to treatment outcome differences. The project uses assessment instruments, computerized adaptive tests (CATs), from the Patient-Reported Outcomes Measurement Information System (PROMIS®). The research team has recently developed and tested (using PROMIS methods) a set of instruments to assess non-specific factors in healing from the patient's perspective. These instruments, the Healing Encounters and Attitudes Lists (HEAL) assess the Patient-Provider Connection, Treatment Expectancy, views of the Healthcare Environment, Positive and Negative Attitudes, Spirituality, and Attitude toward Complementary and Alternative Medicine (CAM). HEAL CAT's, like other PROMIS CATs, are brief, easy to use and understand, and are designed to apply to a broad spectrum of treatments and health conditions. In this project, the investigators aim to 1) evaluate whether HEAL predicts chronic pain treatment outcomes, 2) examine heterogeneity of treatment effects based upon HEAL and PROMIS scores in integrative and conventional medicine settings, and 3) interview patients and their clinicians regarding the utility of HEAL, PROMIS and a Pain Log for enhancing communication. The investigators will administer HEAL CATs and other PROMIS CATs (depression, anxiety, sleep disturbance, fatigue and physical function) to 200 patients who are starting treatment for chronic pain in integrative medicine and conventional medicine settings. Follow-up assessments will be completed 2 and 4 months after baseline testing. The investigators will evaluate factors that may predict which patients judge themselves to be improved, the same, or worsened. Some of the possible factors that may contribute to improvement include HEAL scores, emotional distress, or the preference for CAM or conventional treatment. The investigators are also interested in learning whether patients find the assessments to be clear and useful. A
Primary Outcome
PROMIS Pain Intensity is a three item scale measuring the severity of pain at its worst (past week), average (past week), and current level using a five-point Likert-type scale (i.e., no pain=1, mild=2, moderate=3, severe=4, very severe=5). Scores on the 3 items are summed to create a raw score, which can range from 3 to 15. The raw score is converted to a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.(see htt
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2015-02 |
| Est. Completion | 2017-01 |
What the finished NCT02873429 record still lists
NCT02873429 is an observational study that tracks outcomes without assigning an intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02873429 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02873429 about?
NCT02873429 is a clinical study titled "Measuring the Context of Healing in Chronic Pain Treatment". This project focuses on whether nonspecific factors as well as patient characteristics contribute to treatment outcome differences. The project uses assessment instruments, computerized adaptive tests (CATs), from the Patient-Reported Outcomes Measurement Information System (PROMIS®). The research t...
What is the current status of trial NCT02873429?
This trial is currently completed. The enrollment target is 218 participants. The study started on 2015-02. Estimated completion is 2017-01.
Who is sponsoring clinical trial NCT02873429?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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