Gastrointestinal DiseasesPROCAIMNCT00740233
Web-Based Survey of Pain, Stress and Complementary and Alternative Medicine
An observational study of Gastrointestinal Diseases and Chronic Pain, run by University of California, Los Angeles.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Diseases, Chronic Pain, Stress
- How many people
- 2,300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Everyone who has a computer and is fluent in English will be eligible.
Who cannot join
- 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.
About this study
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.
Read more
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
Read the 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.
- Conditions
- Gastrointestinal Diseases, Chronic Pain, Stress, Anxiety, Depression
- Keywords
- fibromyalgia, irritable bowel syndrome, interstitial cystitis, chronic fatigue syndrome, vulvodynia, chronic stress, chronic pain, stress-related conditions, functional GI disorders
- Medical subject headings
- Gastrointestinal Diseases, Chronic Pain, Anxiety Disorders, Depression, Fibromyalgia, Irritable Bowel Syndrome, Cystitis, Interstitial, Fatigue Syndrome, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress, Mindfulness, Somatization
Online surveys at intervals over 1 year.
Measured: 1,3,6,9,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Deborah Ackerman, Ph.D., Principal investigator, UCLA School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740233
- Sponsor's protocol ID
- PROCAIM2008
- Acronym
- PROCAIM
- Status last verified
- Feb 2009
- First submitted
- 20 Aug 2008
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Based Survey of Pain, Stress and Complementary and Alternative Medicine
- ClinicalTrials.gov ID
- NCT00740233
- Acronym / sponsor ID
- PROCAIM / PROCAIM2008
- Conditions
- Gastrointestinal Diseases, Chronic Pain, Stress, Anxiety, Depression
- Keywords
- fibromyalgia, irritable bowel syndrome, interstitial cystitis, chronic fatigue syndrome, vulvodynia, chronic stress, chronic pain, stress-related conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,300 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jun 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Everyone who has a computer and is fluent in English will be eligible.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perceived Stress, Mindfulness, Somatization
Time frame: 1,3,6,9,12 months
Online surveys at intervals over 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Ackerman, Ph.D. principal investigator
UCLA School of Public Health
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Diseases and Chronic Pain, run by University of California, Los Angeles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress, Mindfulness, Somatization (time frame: 1,3,6,9,12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2014.