Patient Education in Gastroesophageal Reflux Disease | NCT00618150

Studies
Patient Education in Gastroesophageal Reflux Disease

NCT00618150

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Jan 18, 2017Estimated

Enrollment

211Actual

Phase

Not Applicable

Conditions

Gastroesophageal Reflux Disease

Interventions

Patient education

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SLKNR 96/00515

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1996

Primary Completion Date

Dec 1999Actual

Completion Date

Not provided

First Submitted Date

Feb 5, 2008

First Submission Date that Met QC Criteria

Feb 5, 2008

First Posted Date

Feb 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2017

Last Update Posted Date

Jan 18, 2017Estimated

Name	Class
Norwegian Foundation for Health and Rehabilitation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

211Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Behavioral: Patient education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patient education	Behavioral	An educational program: Three lessons spaced over 2 weeks.	A

Measure	Description	Time Frame
Quality of life		one year

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jorgen A Urnes, MD	Norwegian University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Norwegian University of Science and Technology, Med. fac.		Trondheim		NO-7489	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17998836	Result	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.
19014552	Derived	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.

ID	Term
D005764	Gastroesophageal Reflux
D004415	Dyspepsia

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

ID	Term
D006266	Health Education
D011314	Preventive Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services