Patient Education in Gastroesophageal Reflux Disease

NCT ID: NCT00618150

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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A

Group Type EXPERIMENTAL

Patient education

Intervention Type BEHAVIORAL

An educational program: Three lessons spaced over 2 weeks.

Interventions

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Patient education

An educational program: Three lessons spaced over 2 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian Foundation for Health and Rehabilitation

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Norwegian University of Science and Technology

Principal Investigators

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Jorgen A Urnes, MD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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Norwegian University of Science and Technology, Med. fac.

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 17998836 (View on PubMed)

Urnes 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.

Reference Type DERIVED
PMID: 19014552 (View on PubMed)

Other Identifiers

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SLKNR 96/00515

Identifier Type: -

Identifier Source: secondary_id

Sak 33-96 (REK)

Identifier Type: -

Identifier Source: org_study_id

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