Gastroesophageal Reflux DiseaseNCT00618150
Patient Education in Gastroesophageal Reflux Disease
A study testing Patient education in people with Gastroesophageal Reflux Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Patients with gastroesophageal reflux disease (heart-burn, acid regurgitation)may benefit from an educational program explaining the medical aspects of the disease, self-management strategies and how to deal with health services. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteNorway
- Study dates
- Sep 1996to Dec 1999
- Phase
- Interventional
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- heartburn and acid regurgitation the dominant symptom
- needing relief at least 5 days/ week when symptoms were at their worst
- disease history at least 3 months
- ability to give informed consent
Who cannot join
- current or previous esophagitis stage 2(Savary-Miller) or greater or peptic ulc
- continuous need of proton pump inhibitors or NSAIDs
- wish for surgical treatment
- earlier surgical treatment in the GI-tract
- pregnancy
- alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian University of Science and Technology, Med. fac.
Trondheim, NO-7489
About this study
Patients with gastroesophageal reflux disease (heart-burn, acid regurgitation)may benefit from an educational program explaining the medical aspects of the disease, self-management strategies and how to deal with health services. We hypothesized that patients having participated in an educational program would experience an improved quality of life when compared to patients who did not take part (controls).
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Patient education
- Keywords
- GERD, Dyspepsia, Education, Information
- Medical subject headings
- Gastroesophageal Reflux, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient educationBehavioural
An educational program: Three lessons spaced over 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Behavioral: Patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startSep 1996
- Primary completionDec 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation
- Investigators
- Jorgen A Urnes, MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618150
- Sponsor's protocol ID
- Sak 33-96 (REK)
- Other IDs
- SLKNR 96/00515
- Status last verified
- Jan 2017
- First submitted
- 5 Feb 2008
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Urnes J, Farup PG, Lydersen S, Petersen H. Patient education in gastro-oesophageal reflux disease: a randomized controlled trial. Eur J Gastroenterol Hepatol. 2007 Dec;19(12):1104-10. doi: 10.1097/MEG.0b013e3282f163dc.
PubMed 17998836Urnes J, Petersen H, Farup PG. Disease knowledge after an educational program in patients with GERD--a randomized controlled trial. BMC Health Serv Res. 2008 Nov 13;8:236. doi: 10.1186/1472-6963-8-236.
PubMed 19014552
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Education in Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT00618150
- Acronym / sponsor ID
- Sak 33-96 (REK)
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, Dyspepsia, Education, Information
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation
- Study start
- Sep 1996
- Primary completion
- Dec 1999 (actual)
- First posted
- 18 Feb 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.
Patients with gastroesophageal reflux disease (heart-burn, acid regurgitation)may benefit from an educational program explaining the medical aspects of the disease, self-management strategies and how to deal with health services. We hypothesized that patients having participated in an educational program would experience an improved quality of life when compared to patients who did not take part (controls).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Patient education |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- heartburn and acid regurgitation the dominant symptom
- needing relief at least 5 days/ week when symptoms were at their worst
- disease history at least 3 months
- ability to give informed consent
Key exclusion criteria (6 listed)
- current or previous esophagitis stage 2(Savary-Miller) or greater or peptic ulc
- continuous need of proton pump inhibitors or NSAIDs
- wish for surgical treatment
- earlier surgical treatment in the GI-tract
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient educationAn educational program: Three lessons spaced over 2 weeks. | Behavioural | A |
Primary outcome
Quality of life
Time frame: one 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 18 Jan 2017.
- Results publication: PubMed 17998836Urnes J, Farup PG, Lydersen S, Petersen H. Patient education in gastro-oesophageal reflux disease: a randomized controlled trial. Eur J Gastroenterol Hepatol. 2007 Dec;19(12):1104-10. doi: 10.1097/MEG.0b013e3282f163dc.
- Derived from this study: PubMed 19014552Urnes J, Petersen H, Farup PG. Disease knowledge after an educational program in patients with GERD--a randomized controlled trial. BMC Health Serv Res. 2008 Nov 13;8:236. doi: 10.1186/1472-6963-8-236.
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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.
Jorgen A Urnes, MD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education in people with Gastroesophageal Reflux Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 inclusion and 6 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 18 Jan 2017. 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 Norway. 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?
Quality of life (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00618150, which also lists 2 linked publications.
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 18 Jan 2017.