Web-Based Survey of Pain, Stress and Complementary and Alternative Medicine (PROCAIM)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00740233
First received: August 20, 2008
Last updated: March 26, 2014
Last verified: February 2009
  Purpose

The investigators are inviting people with fibromyalgia, IBS, interstitial cystitis, chronic pain, and other chronic and recurring conditions to sign up and participate in a year-long Internet-based survey to study the effectiveness of alternative medicine and the interactions among stress and coping, pain, and treatment outcomes.

The survey is called PROCAIM, which stands for Patient-Reported Outcomes from Complementary, Alternative, and Integrative Medicine. PROCAIM was developed under a grant to UCLA researchers from the National Center for Complementary and Alternative Medicine.

This is a web-based study composed of surveys that will recur at intervals over 1 year!

TO ENROLL

  • Log in to our web site: http://www.procaim.org/
  • Register as a New User.
  • Select clinic name: ClinicalTrials.gov.
  • Read and sign the Consent Form.

After participants"sign" the form with their email address, participants can begin to answer the first in a series of questionnaires. The system will send participants email reminders at the time of each scheduled follow-up for one year.

For further information about PROCAIM, please contact:

  • Deborah Ackerman, Ph.D.
  • Department of Epidemiology
  • UCLA School of Public Health
  • Box 951772
  • Los Angeles, CA 90095-1772
  • deborah.ackerman@ucla.edu

Condition
Gastrointestinal Diseases
Chronic Pain
Stress
Anxiety
Depression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Perceived Stress, Mindfulness, Somatization [ Time Frame: 1,3,6,9,12 months ] [ Designated as safety issue: No ]
    Online surveys at intervals over 1 year.


Enrollment: 2300
Study Start Date: June 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:

PROCAIM, which stands for Patient-Reported Outcomes from Complementary, Alternative, and Integrative Medicine, was developed to collect and manage longitudinal patient data and implement patient-based outcomes assessment protocols at clinical sites around the country that offer various forms of CAM as well as clinics that provide the combination of conventional medicine with complementary and alternative therapies. PROCAIM is currently being used for a 12 month longitudinal survey to evaluate interactions among stress, symptoms, severity, and general well-being among people with fibromyalgia, IBS, chronic fatigue, and other chronic pain conditions, and the frequency and impact of co-morbid conditions among users of complementary and alternative medicines.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

In general, participants will be: at least 18 years of age; ambulatory (i.e., not depending upon a wheelchair for mobility); and meet general criteria for psychosomatic or functional disorders including irritable bowel syndrome, other functional disorders, fibromyalgia, chronic pain, or related mood and anxiety disorders.

Criteria

Inclusion Criteria:

  • Everyone who has a computer and is fluent in English will be eligible.

Exclusion Criteria:

  • Only people with access to personal computers and the Internet and fluency in English will be able to participate. These exclusions are not based on age, gender, pregnancy, racial, or ethnic origin.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740233

Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Deborah Ackerman, Ph.D. UCLA School of Public Health
  More Information

No publications provided

Responsible Party: Deborah Ackerman, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00740233     History of Changes
Other Study ID Numbers: PROCAIM2008
Study First Received: August 20, 2008
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
fibromyalgia
irritable bowel syndrome
interstitial cystitis
chronic fatigue syndrome
vulvodynia
chronic stress
chronic pain
stress-related conditions
functional GI disorders

Additional relevant MeSH terms:
Depression
Chronic Pain
Gastrointestinal Diseases
Digestive System Diseases
Behavioral Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014