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Patient Education in Gastroesophageal Reflux Disease

This study has been completed.
Sponsor:
Collaborator:
Norwegian Foundation for Health and Rehabilitation
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00618150
First received: February 5, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

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).


Condition Intervention
Gastroesophageal Reflux Disease
 Behavioral: Patient education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Patient Education in Gastroesophageal Reflux Disease

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 211
Study Start Date: September 1996
Primary Completion Date: December 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Behavioral: Patient education
An educational program: Three lessons spaced over 2 weeks.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618150

Locations
Norway
Norwegian University of Science and Technology, Med. fac.
Trondheim, Norway, NO-7489
Sponsors and Collaborators
Norwegian University of Science and Technology
Norwegian Foundation for Health and Rehabilitation
Investigators
Principal Investigator: Jorgen A Urnes, MD Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Jorgen Urnes/ principal researcher, Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00618150     History of Changes
Other Study ID Numbers: Sak 33-96 (REK), SLKNR 96/00515
Study First Received: February 5, 2008
Last Updated: February 5, 2008
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
GERD
Dyspepsia
Education
Information

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013