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The Healing Context in Complementary and Alternative Medicine (CAM): Initial Validation Study (HEAL)

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ClinicalTrials.gov Identifier: NCT02161887
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Carol Greco, University of Pittsburgh

Brief 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 final, Validation 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 or neck pain who are receiving physical therapy, chiropractic care, acupuncture, medical management, 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.

Condition or disease
Chronic Low Back Pain Neck Pain

Detailed Description:
This project will develop and test a set of patient self-report measurement tools to assess the perceived contextual factors, such as patient attitudes and expectations, patient provider relationship factors, and environmental factors that contribute to healing. This project is synergistic with the National Institutes of Health (NIH) Roadmap initiative, Patient Reported Outcomes Measurement Information System (PROMIS), and will use the rigorous instrument development and validation methodology of PROMIS. The overall objective of this study is to develop efficient self-report instruments to measure CAM-relevant contextual factors important in healing, hereafter referred to as the Healing Encounters and Attitudes Lists (HEAL), and conduct initial validation in persons seeking CAM and conventional treatment for pain. Specific Aim 1: Develop item banks. The investigators will employ several iterative steps used successfully in PROMIS to identify items that assess contextual factors of healing relevant to CAM. Initial steps in developing item banks include: a) compilation and evaluation of existing instruments and relevant questions, b) consultation with experts, and c) focus groups with individuals who participate in CAM and conventional medicine interventions, and d) item editing. During the initial phase of this study, the investigators expect to identify conceptual areas of potential importance to CAM interventions and patients, and identify and edit items to create item banks assessing these conceptual areas. Specific Aim 2: Calibrate items. The investigators will use item response theory (IRT) and classical test theory (CTT) to calibrate the items from Aim 1 on three samples: 1) an internet-based sample (n= 1400), 2) 125 outpatients participating in CAM interventions at the Center for Integrative Medicine (CIM), and 3) 125 outpatients at a General Internal Medicine clinic. During year 3-4 the investigators will administer the items in the item banks to the 1650 persons, conduct IRT and CTT analyses and refine the item banks to only those items that best assess the constructs. Specific aim 2 will result in Computerized Adaptive Testing (CAT) versions of the HEAL, which maximizes information while minimizing patient time burden. Static short forms of the HEAL item banks will be derived from the HEAL CATs in Aim 2. Specific Aim 3: Conduct initial validation studies. The investigators will evaluate convergent, discriminant, and predictive validity of the Healing Encounters and Attitudes List (HEAL) in a sample of chronic low back pain (CLBP) or neck pain patients receiving CAM and conventional medicine treatments. The validity studies will use two samples of adults with CLBP: 100 persons receiving CAM treatments: chiropractic manipulation (CM), acupuncture, or mindfulness-based stress reduction (MBSR) at the CIM, and 100 persons receiving conventional care (physical therapy or medical management) at the University of Pittsburgh Medical Center (UPMC). The investigators will administer the CAT version of the HEAL questionnaire developed in aims 1 and 2 as well as conventional measures of treatment expectancy, confidence in treatment provider, psychosocial functioning, and pain and disability treatment outcome measures for CLBP and neck pain. • Hypothesis 3a: Scores on the HEAL measures will display moderate to large correlations (r's > .50) with similar self-report measures, supporting convergent validity. • Hypothesis 3b: Scores on the HEAL measures will correlate modestly (r's = .20-.35) with self-report measures of general psychosocial functioning, supporting discriminant validity. • Hypothesis 3c: HEAL scores will account for a significant proportion of variance in treatment outcome in both samples. In addition, the investigators predict that HEAL scores will demonstrate incremental validity, i.e., the scores will account for significant incremental variance in outcome beyond that accounted for by existing measures of treatment expectancy and related constructs.

Study Type : Observational
Actual Enrollment : 207 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The Healing Context in CAM: Instrument Development and Initial Validation - Phase 3 Validation Study
Study Start Date : June 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Group/Cohort
Complementary Medicine Group
Patients receiving chiropractic care, acupuncture, or meditation for chronic pain
Conventional Medicine Group
Patients receiving conventional medicine care (physical therapy, medication management) for chronic pain.



Primary Outcome Measures :
  1. Clinical Global Impression of Change (CGI) [ Time Frame: 6 - 8 weeks, 4 months post study entry ]

Secondary Outcome Measures :
  1. Roland and Morris Disability Questionnaire [ Time Frame: Baseline, 6-8 weeks, 4 months post baseline ]

Other Outcome Measures:
  1. Neck Disability Index [ Time Frame: Baseline, 6-8 weeks, 4 months post baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are beginning or about to begin CAM or Conventional Medicine treatments for chronic back pain or chronic neck pain in Pittsburgh, Pennsylvania at University of Pittsburgh Medical Center (UPMC).
Criteria

Inclusion Criteria:

  • 18 years old or older; able to read and understand English; able to use a computer; starting a new treatment for back or neck pain, or started treatment within the past month.

Exclusion Criteria:

  • psychotic disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161887


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
UPMC General Clinical Research Center
Pittsburgh, Pennsylvania, United States, 15213
UPMC Shadyside Center for Integrative Medicine
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Carol M Greco, Ph.D. University of Pittsburgh