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Patient Education in Gastroesophageal Reflux Disease

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Patient education
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Gastroesophageal Reflux Disease focused on measuring GERD, Dyspepsia, Education, Information

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norwegian University of Science and Technology, Med. fac.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Quality of life

Secondary Outcome Measures

Full Information

First Posted
February 5, 2008
Last Updated
January 16, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
Norwegian Foundation for Health and Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT00618150
Brief Title
Patient Education in Gastroesophageal Reflux Disease
Official Title
Patient Education in Gastroesophageal Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 1996 (undefined)
Primary Completion Date
December 1999 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Norwegian Foundation for Health and Rehabilitation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
GERD, Dyspepsia, Education, Information

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Patient education
Intervention Description
An educational program: Three lessons spaced over 2 weeks.
Primary Outcome Measure Information:
Title
Quality of life
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorgen A Urnes, MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian University of Science and Technology, Med. fac.
City
Trondheim
ZIP/Postal Code
NO-7489
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
17998836
Citation
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.
Results Reference
result
PubMed Identifier
19014552
Citation
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.
Results Reference
derived

Learn more about this trial

Patient Education in Gastroesophageal Reflux Disease

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