NCT05937204

Brief Summary

The aims of the study are:

  • Assess patient's level of knowledge regarding gastroesophageal reflux disease.
  • Assess patient' compliance and symptoms of gastroesophageal reflux disease.
  • Design and implement nursing teaching scheme for patients with gastroesophageal reflux disease.
  • Evaluate the effect of nursing teaching scheme on patient' compliance and symptoms of gastroesophageal reflux disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 12, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

June 20, 2023

Last Update Submit

July 10, 2023

Conditions

Keywords

ComplianceSymptoms

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Symptoms of Gastroesophageal Reflux Disease

    Gastro-esophageal Reflux Disease Questionnaire. It is composed of 6 items and uses a four-graded Likert scale (0-3) to score four positive predictors of GERD (heartburn, regurgitation, sleep disturbance due to reflux symptoms, and over the medications for reflux symptoms) and a reversed Likert scale (3-0) for two negative predictors (epigastric pain and nausea), giving a total GERD score range of 0-18. The maximum score that can be obtained is 18 divided as follows mild (0- 6), moderate (7- 12) and sever (13-18)

    "4Weeks"

Secondary Outcomes (1)

  • Compliance with Medication

    "4Weeks"

Study Arms (1)

one group pre- test post- test

EXPERIMENTAL
Other: Nursing Teaching

Interventions

A nursing teaching scheme refers to a systematic and structured plan developed by nurses to provide teaching and instruction to patients. The components of a nursing teaching scheme typically include assessing learning needs, setting learning objectives, developing teaching materials, delivering information using various teaching methods, demonstrating skills, providing written instructions, assessing learning outcomes, and conducting follow-up

one group pre- test post- test

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of gastroesophageal reflux disease

You may not qualify if:

  • Peptic ulcer
  • Esophageal cancer
  • Esophageal surgery
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing Assiut University

Asyut, Egypt

Location

Related Publications (1)

  • Fox M, Gyawali CP. Dietary factors involved in GERD management. Best Pract Res Clin Gastroenterol. 2023 Feb-Mar;62-63:101826. doi: 10.1016/j.bpg.2023.101826. Epub 2023 Feb 17.

MeSH Terms

Conditions

Gastroesophageal RefluxPatient Compliance

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • shalabia elsayed abuozead, professor

    faculty of nursing - assiut university

    STUDY CHAIR

Central Study Contacts

Asmaa mahmoud Goumaa mahmoud, assistant lecturer

CONTACT

Mohamed Ahmed medhat, assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

June 20, 2023

First Posted

July 10, 2023

Study Start

July 1, 2023

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

July 12, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations