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

February 28, 2017 updated by: Carol Greco, University of Pittsburgh

The Healing Context in CAM: Instrument Development and Initial Validation - Phase 3 Validation 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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

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

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Shadyside Center for Integrative Medicine
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC General Clinical Research Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Clinical Global Impression of Change (CGI)
Time Frame: 6 - 8 weeks, 4 months post study entry
6 - 8 weeks, 4 months post study entry

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Roland and Morris Disability Questionnaire
Time Frame: Baseline, 6-8 weeks, 4 months post baseline
Baseline, 6-8 weeks, 4 months post baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Neck Disability Index
Time Frame: Baseline, 6-8 weeks, 4 months post baseline
Baseline, 6-8 weeks, 4 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carol M Greco, Ph.D., University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AT006453-3

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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