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Registry for Integrative Medicine Interventions Effectiveness (PRIMIER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01754038
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
The Bravewell Collaborative
Information provided by (Responsible Party):
BraveNet

Brief Summary:

This registry will perform prospective surveillance of participants attending collaborating Integrative Medicine clinic sites for clinical services. All decisions about medication use, treatments, visit frequency, assessment of tolerance, and other aspects of patient management will be left to the clinical providers' discretion. We will attempt to follow the participants in the PRIMIER Registry for up to 2 years.

Essential data elements that capture patient-reported outcomes and measures of clinical activity will be obtained at approximately 2-month intervals for the first 6 months, then every 6 months through the end of year 2.


Condition or disease
All Conditions of Integrative Medicine Clinic Patients

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Study Type : Observational [Patient Registry]
Actual Enrollment : 5069 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Patients Receiving Integrative Medicine Interventions Effectiveness Registry
Study Start Date : August 2013
Actual Primary Completion Date : December 2018
Actual Study Completion Date : January 2019

Group/Cohort
Integrative Medicine Clinic Attendees
All patients attending a participating Integrative Medicine clinic for clinical services will be invited to participate in the PRIMIER Registry



Primary Outcome Measures :
  1. PROMIS® CAT [ Time Frame: Baseline, 2, 4, 6 months, then every 6 months through year 2,. ]
    PROMIS® can integrate Item Response Theory (IRT) with computers to administer a PRO instrument. IRT selects questions on the basis of a patient's response to previously administered questions, measurement is "adapted" to individual, skips uninformative items to minimize response burden and allows determination of person's standing on a domain without a loss in measurement precision. The PROMIS® CAT for PRIMIER will be designed to assess anxiety, depression, sleep disturbance, fatigue, pain interference, physical function, and satisfaction with participation in social roles. Questions will be answered electronically using a standard 1-5 Likert scale. Participants will answer between 4 and 12 questions per domain, for a total of 29 to 85 questions.


Secondary Outcome Measures :
  1. Perceived Stress Scale - 4 [ Time Frame: Baseline, 2, 4, 6 months, then every 6 months through year 2. ]
    The PSS-4 is brief, validated and widely used psychological instrument for assessing a participant's perception of stress change. The PSS-4 consists of 4 questions to measure the degree to which situations in the participant's life are perceived as stressful including questions related to perceived unpredictability and lack of control. Participants choose responses ranging from never (0) to very often (4) with a total score ranging from 0 to 16.

  2. Patient Activation Measure (PAM) [ Time Frame: Baseline, 2, 4, 6 months, then every 6 months through year 2. ]
    The PAM is a brief, validated instrument for gauging the knowledge, skills and confidence essential to managing one's own health and healthcare. The 13-item PAM assessment segments consumers into one of four progressively higher activation levels. Each level addresses a broad array of self-care behaviors and offers deep insight into the characteristics that drive health activation.

  3. Cost Indicators [ Time Frame: Every 6 months ]
    From the subjects' medical and financial records we will capture ICD codes, CPT codes, and payments made by subjects and their insurance companies.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients attending a participating Integrative Medicine Clinic
Criteria

Inclusion Criteria:

  • Be seen as a clinical patient in one of the participating Integrative Medicine (IM) clinics and willing to participate in the Registry
  • Be 18 years of age or older
  • Have access to a computer with internet connection and a valid email address
  • Be willing to be contacted in the future by study investigators

Exclusion Criteria:

  • Not being seen by a provider for clinical purposes, but only involved in an education program or one-time activity

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): NCT01754038


Locations
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United States, California
Scripps Center for Integrative Medicine
La Jolla, California, United States, 92037
UCSF Osher Center for Integrative Medicine
San Francisco, California, United States, 94143
Venice Family Clinic at Simms/Mann Health and Wellness Center
Santa Monica, California, United States, 90405
United States, Colorado
University of Colorado School of Medicine, Center for Integrative Medicine
Aurora, Colorado, United States, 80045
United States, Illinois
Northwestern Integrative Medicine - Northwestern Memorial Physicians Group
Chicago, Illinois, United States, 60611
United States, Maryland
University of Maryland Center for Integrative Medicine
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Program for Integrative Medicine and Health Care Disparities
Boston, Massachusetts, United States, 02118
United States, Minnesota
Penny George Institute for Health and Healing
Minneapolis, Minnesota, United States, 55407
United States, New York
Beth Israel Integrative Medicine Continuum Center for Health and Healing
New York, New York, United States, 10016
United States, North Carolina
Duke Integrative Medicine Clinic
Durham, North Carolina, United States, 27705
United States, Ohio
Alliance Institute for Health and Healing
Cincinnati, Ohio, United States, 45236
United States, Pennsylvania
Jefferson-Myrna Brind Center of Integrative Medicine
Philadelphia, Pennsylvania, United States, 19107
UPMC Shadyside Center for Integrative Medicine
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Vanderbilt Center for Integrative Health
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
BraveNet
The Bravewell Collaborative
Investigators
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Principal Investigator: Donald I Abrams, MD University of California, San Francisco
Principal Investigator: Jeffrey A Dusek, PhD Penny George Institute for Health and Healing, Abbott Northwestern Hospital
Study Director: Diane McKee, MD MS Albert Einstein College of Medicine
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: BraveNet
ClinicalTrials.gov Identifier: NCT01754038    
Other Study ID Numbers: Pro00040886
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Keywords provided by BraveNet:
Patient Reported Outcomes
PRO
Registry