Implementation of the Nurse Navigation Program (rct)

March 30, 2023 updated by: Gülistan YURDAGÜL, Kilis 7 Aralik University

İnvestigation of the Effect on Nurse Navigation Program on Compliance, Quality of Life and Prevention of Complications in Patients With Stoma

This study was conducted as a randomized controlled intervention study with repetitive measurements in a pretest-posttest order to examine the effect of nurse navigation program on compliance, quality of life and prevention of complications in patients with intestinal stoma. The study was completed with 30 experimental and 28 control group patients with intestinal stoma in six hospitals, two of which are training and research hospitals, located in Gaziantep city center, between January 1 and December 31, 2021. While counseling, remote support, written and visual trainings, informative messages, phone calls, and appointment scheduling were applied to the patients in the experimental group within the scope of the nurse navigation program, the patients in the control group received standard care

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was conducted as a randomized controlled intervention study with repetitive measurements in a pretest-posttest order to examine the effect of nurse navigation program on compliance, quality of life and prevention of complications in patients with intestinal stoma. The study was completed with 30 experimental and 28 control group patients with intestinal stoma in six hospitals, two of which are training and research hospitals, located in Gaziantep city center, between January 1 and December 31, 2021. While counseling, remote support, written and visual trainings, informative messages, phone calls, and appointment scheduling were applied to the patients in the experimental group within the scope of the nurse navigation program, the patients in the control group received standard care. The patients were evaluated using the Patient Information Form, Stoma Complications Evaluation Form, Stoma-Related Problems Experienced Form, Ostomy Compliance Scale, and Stoma Quality of Life Scale at the first interview, at the third and sixth months.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kilis, Turkey, 79000
        • Kilis 7 Aralık Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

patients with intestinal stoma

Description

Inclusion Criteria:with intestinal stoma

  • Having no mental handicap or perception problems and no communication difficulties
  • No psychiatric disease
  • 18 years old and over
  • literate
  • Capable of using a smartphone
  • No vision and hearing problems
  • Those who have the physical ability to change the stoma bag themselves.
  • Patients with intestinal stoma for a maximum of two months were included in the study.

Exclusion Criteria:

  • After agreeing to participate in the research, wanting to leave,

    • Those who died during the research process,
    • The stoma was closed during the research process,
    • Patients whose communication could not be maintained during the research process

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
deney grubu

adult patients with intestinal stoma: The first interview: the patients were informed about the purpose of the study and signed informed consent form. The training booklet was delivered to them. Their contact information was obtained and the contact information of the researcher (navigator nurse) was shared with them. They were told that they could call the navigator nurse, send a message to him/her, take a photo of the stoma and share it with his/her when necessary, when they had physical, social, and psychological problems in the stoma or in line with their changing needs. In the next 3 months, they were informed about the applications to be made within the scope of the study (phone calls, information messages and videos, guidance and appointment planning). Appointment was scheduled for the next interview in 3 months.

.
Behavioral: implementation of the nurse navigation program
Adult patients with intestinal stoma were contacted continuously for 6 months.
kontrol grubu

adult patients with intestinal stoma: The first interview: the patients were informed about the purpose of the study and signed informed consent form. All of the data collection tools were filled out. Their questions about stoma care were answered. Training booklet was handed down to them. An appointment was scheduled for the next interview 3 months later.

The second interview (3 months after the first interview): A few days before the interview, they were called up and reminded of their appointment. The relevant forms were filled out with them at the end of the 3rd month. Their questions about stoma care were answered. An appointment was scheduled for the next interview 3 months later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stoma compliance
Time Frame: 6 month
stoma compliance scale
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
life quality
Time Frame: 6 month
quality of life scale
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kilis 7 Aralik University

Investigators

  • Study Director: nuran tosun, prof, nuran.tosun@hku.edu.tr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19862023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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