NCT05809661

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

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

January 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

January 31, 2023

Last Update Submit

March 30, 2023

Conditions

Keywords

Nursing, Navigation Program, Stoma, Compliance

Outcome Measures

Primary Outcomes (1)

  • stoma compliance

    stoma compliance scale

    6 month

Secondary Outcomes (1)

  • life quality

    6 month

Study Arms (2)

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

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.

Interventions

Adult patients with intestinal stoma were contacted continuously for 6 months.

deney grubu

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with intestinal stoma

You may qualify if:

  • Having no mental handicap or perception problems and no communication difficulties
  • No psychiatric disease
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kilis 7 Aralık Üniversitesi

Kilis, 79000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intestinal NeoplasmsPatient Compliance

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • nuran tosun, prof

    nuran.tosun@hku.edu.tr

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prelector

Study Record Dates

First Submitted

January 31, 2023

First Posted

April 12, 2023

Study Start

January 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 12, 2023

Record last verified: 2023-03

Locations