NCT00618150

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1996

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1999

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

3.2 years

First QC Date

February 5, 2008

Last Update Submit

January 16, 2017

Conditions

Gastroesophageal Reflux Disease

Keywords

GERDDyspepsiaEducationInformation

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    one year

Study Arms (1)

A

EXPERIMENTAL
Behavioral: Patient education

Interventions

Patient educationBEHAVIORAL

An educational program: Three lessons spaced over 2 weeks.

A

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology, Med. fac.

Trondheim, NO-7489, Norway

Location

Related Publications (2)

  • 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.

    PMID: 17998836RESULT

  • 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.

    PMID: 19014552DERIVED

MeSH Terms

Conditions

Gastroesophageal RefluxDyspepsia

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jorgen A Urnes, MD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2008

First Posted

February 18, 2008

Study Start

September 1, 1996

Primary Completion

December 1, 1999

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

NO(1)