Rheumatic DiseasesNCT00665275
Complementary and Alternative Medicine Among Outpatients With Inflammatory Rheumatic Diseases in Western Sweden
An observational study of Rheumatic Diseases, run by Göteborg University at 1 site in Sweden.
Trial summary
This is an observational study aiming to study the use of complementary and alternative medicine (CAM) drugs and methods among patients with inflammatory rheumatic diseases, at Rheumatology clinics in western Sweden and also to investigate possible associations between CAM using habits and other characteristics of the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatic Diseases
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2007to Jul 2007
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lists of outpatients who were scheduled for appointments at the rheumatology clinic were sent to an external randomizer, to randomly elect patients who were asked to participate. Patients were eligible for inclusion if they were attending the rheumatology clinic and had had an appointment there before. Patients were excluded if they were on their first visit to the practice, had dementia or had difficulties understanding Swedish.
Who may be able to join
- Patients were eligible for inclusion if they were attending the rheumatology clinic and had had an appointment there before.
Who cannot join
- Patients were excluded if they were on their first visit to the practice, had dementia or had difficulties understanding Swedish.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Rheumatology, Sahlgrenska University Hospital
Gothenburg, S-413 46
About this study
Official title: The Use of Complementary and Alternative Medicine Among Outpatients With Inflammatory Rheumatic Diseases in Western Sweden.
This is an observational study aiming to study the use of complementary and alternative medicine (CAM) drugs and methods among patients with inflammatory rheumatic diseases, at Rheumatology clinics in western Sweden and also to investigate possible associations between CAM using habits and other characteristics of the patients.
Read the detailed description
Complementary and alternative medicine (CAM) is treatment that primarily is given outside the institutions where conventional medicine is practised. CAM drugs are substances that often have a natural origin and are taken orally or used topically, for self-treatment. CAM methods are therapies where the patient often goes to a practitioner, for example acupuncture, massage, homeopathy or chiropractics.
Most cultures have their own history of traditional treatments, with herbal medicine or spiritual healers.
The use of complementary and alternative medicine (CAM) is widespread and increasing in many countries. The sales figures in Sweden for CAM drugs, functional foods and dietary supplements have increased from 450 million to 4250 million SEK between 1980 and 2007. Many people of today use CAM as a complement, rather than an alternative, to conventional healthcare. Some alternative methods, like acupuncture and massage, have also been integrated into conventional medicine.
The biological effects of drugs containing herbs or animal parts are often unknown and there is a hazard of interaction with prescribed medication.
The use of CAM drugs is often not communicated by the patient to the physician. A Swedish point observation study of patients admitted to Sahlgrenska hospital 2004 showed that 69 % of the patients had used CAM drugs at any time in their life, but only 27,5% had informed their doctor about it. The use of CAM drugs was seldom documented in the medical records of the patient.
The utilization of CAM among patients with rheumatic diseases in Sweden has never been studied before.
The aim of this trial was to study the use of CAM methods and CAM drugs among patients seen at rheumatology practises in the west of Sweden. To investigate which methods and drugs that are being used and to see if there are connections between using habits and factors like gender, age, rheumatic diagnoses, disease activity, medication and the patients experience of pain, fatigue and general health. We were also interested in finding out the reason for use of CAM, and if the patients had experienced beneficial effects or side effects of the use.
- Conditions
- Rheumatic Diseases
- Keywords
- complementary, alternative, medicine
- Medical subject headings
- Rheumatic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of complementary and alternative medicine (CAM) drugs and methods among patients with inflammatory rheumatic diseases in western Sweden.
Measured: July 2007
Secondary outcomes (1)
To investigate potential significant associations between CAM using habits and characteristics of the patients.
Measured: July 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startMar 2007
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Investigators
- Helena Forsblad d'Elia, MD, PhD, Principal investigator, Department of Rheumatology and Inflammation Research, Sahlgrenska Academy at University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665275
- Sponsor's protocol ID
- VGFOUREG-8462
- Other IDs
- VGFOUREG-12277
- Status last verified
- Apr 2008
- First submitted
- 18 Apr 2008
- Last updated
- 23 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Complementary and Alternative Medicine Among Outpatients With Inflammatory Rheumatic Diseases in Western Sweden.
- ClinicalTrials.gov ID
- NCT00665275
- Acronym / sponsor ID
- VGFOUREG-8462
- Conditions
- Rheumatic Diseases
- Keywords
- complementary, alternative, medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 23 Apr 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.
This is an observational study aiming to study the use of complementary and alternative medicine (CAM) drugs and methods among patients with inflammatory rheumatic diseases, at Rheumatology clinics in western Sweden and also to investigate possible associations between CAM using habits and other characteristics of the patients.
Detailed description
Complementary and alternative medicine (CAM) is treatment that primarily is given outside the institutions where conventional medicine is practised. CAM drugs are substances that often have a natural origin and are taken orally or used topically, for self-treatment. CAM methods are therapies where the patient often goes to a practitioner, for example acupuncture, massage, homeopathy or chiropractics.
Most cultures have their own history of traditional treatments, with herbal medicine or spiritual healers.
The use of complementary and alternative medicine (CAM) is widespread and increasing in many countries. The sales figures in Sweden for CAM drugs, functional foods and dietary supplements have increased from 450 million to 4250 million SEK between 1980 and 2007. Many people of today use CAM as a complement, rather than an alternative, to conventional healthcare. Some alternative methods, like acupuncture and massage, have also been integrated into conventional medicine.
The biological effects of drugs containing herbs or animal parts are often unknown and there is a hazard of interaction with prescribed medication.
The use of CAM drugs is often not communicated by the patient to the physician. A Swedish point observation study of patients admitted to Sahlgrenska hospital 2004 showed that 69 % of the patients had used CAM drugs at any time in their life, but only 27,5% had informed their doctor about it. The use of CAM drugs was seldom documented in the medical records of the patient.
The utilization of CAM among patients with rheumatic diseases in Sweden has never been studied before.
The aim of this trial was to study the use of CAM methods and CAM drugs among patients seen at rheumatology practises in the west of Sweden. To investigate which methods and drugs that are being used and to see if there are connections between using habits and factors like gender, age, rheumatic diagnoses, disease activity, medication and the patients experience of pain, fatigue and general health. We were also interested in finding out the reason for use of CAM, and if the patients had experienced beneficial effects or side effects of the use.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lists of outpatients who were scheduled for appointments at the rheumatology clinic were sent to an external randomizer, to randomly elect patients who were asked to participate. Patients were eligible for inclusion if they were attending the rheumatology clinic and had had an appointment there before. Patients were excluded if they were on their first visit to the practice, had dementia or had difficulties understanding Swedish.
Key inclusion criteria (1 listed)
- Patients were eligible for inclusion if they were attending the rheumatology clinic and had had an appointment there before.
Key exclusion criteria (1 listed)
- Patients were excluded if they were on their first visit to the practice, had dementia or had difficulties understanding Swedish.
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
The prevalence of complementary and alternative medicine (CAM) drugs and methods among patients with inflammatory rheumatic diseases in western Sweden.
Time frame: July 2007
1 secondary outcome
To investigate potential significant associations between CAM using habits and characteristics of the patients.
Time frame: July 2007
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 23 Apr 2008.
Related trials for Rheumatic Diseases
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
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.
Helena Forsblad d'Elia, MD, PhD principal investigator
Department of Rheumatology and Inflammation Research, Sahlgrenska Academy at University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Diseases, run by Göteborg University at 1 site in Sweden.
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 23 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The prevalence of complementary and alternative medicine (CAM) drugs and methods among patients with inflammatory rheumatic diseases in western Sweden. (time frame: July 2007). 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 23 Apr 2008.