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NCT01904838 · ClinicalTrials.gov registry record
The Healing Context in CAM: Instrument Development and Initial Validation - Calibration Study
A clinical trial, sponsored by University of Pittsburgh.
- Completed
- Registry status
- 1,650
- Enrollment target
NCT01904838: Completed study, sponsored by University of Pittsburgh.
NCT01904838 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 1,650 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01904838 has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- 1,650 participants
- Enrollment target
Study Summary
The overall objective of this study is to develop and test an efficient set of self-report instruments to measure Complementary and Alternative Medicine(CAM)-relevant contextual factors important in healing. The initial phase of the study involves developing and refining an item bank. During the initial 'item bank development' phase, the investigators will run focus groups and cognitive interviews with individuals who participate in CAM and conventional medicine interventions. The next step of instrument development is called Calibration, and involves administering the revised item bank to an internet sample and to persons who receive services in a CAM clinic and a conventional primary care setting. The items will be calibrated using item response theory and classical test theory. This will result in a computerized adaptive testing version of the instrument, as well as a static short form of the instrument. This current protocol in ClinicalTrials.gov pertains only to the Calibration Phase of the study. The final phase of the project will involve conducting initial validation studies of the set of instruments. The set of instruments will be called the Healing Encounters and Attitudes Lists (HEAL). The investigators will evaluate the convergent, discriminant, and predictive validity of the HEAL instruments in a sample of 200 persons with chronic low back pain who are receiving physical therapy, chiropractic care, or mindfulness-based stress reduction. For convergent validity, the HEAL is expected to display moderate to large correlations with measures of similar constructs. The HEAL is expected to correlate modestly with self-report measures of general psychosocial functioning, in support of discriminant validity. Finally, HEAL scores should account for a significant proportion of the variance in treatment outcome, supporting predictive validity.
Primary Outcome
Participants' opinions regarding factors that contribute to healing, such as important patient characteristics, provider characteristics, and environmental factors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,650 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-11 |
What the finished NCT01904838 record still lists
NCT01904838 is an observational study that tracks outcomes without assigning an intervention. Its 1,650 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT01904838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01904838 about?
NCT01904838 is a clinical study titled "The Healing Context in CAM: Instrument Development and Initial Validation - Calibration Study". The overall objective of this study is to develop and test an efficient set of self-report instruments to measure Complementary and Alternative Medicine(CAM)-relevant contextual factors important in healing. The initial phase of the study involves developing and refining an item bank. During the ini...
What is the current status of trial NCT01904838?
This trial is currently completed. The enrollment target is 1,650 participants. The study started on 2012-09. Estimated completion is 2014-11.
Who is sponsoring clinical trial NCT01904838?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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