NCT06269276

Brief Summary

This study was conducted to evaluate the Turkish validity and reliability of the Caregiver Contribution to Self-Care in Ostomy Patient Index, to evaluate the relatives of patients with stoma who contribute to their self-care in Turkish society, and to contribute to the nursing literature of the measurement tool. This methodological type of research was carried out between September 2020 and January 2021 in a state and a university hospital in Tekirdağ. The research sample consisted of 223 individuals who contributed to the self-care of individuals with colostomy, ileostomy and urostomy who applied for outpatient control. In the analysis of the data, descriptive statistics, language and content validity, confirmatory factor analysis, item analysis, internal consistency and test-retest methods were used. At the end of the study, it was determined that the scale was suitable for Turkish society and was valid and reliable in Turkish.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

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

September 20, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

February 12, 2024

Last Update Submit

February 20, 2024

Conditions

Keywords

caregiverstomaself care

Outcome Measures

Primary Outcomes (1)

  • Caregiver Contribution to Self-Care in Ostomy Patient Index

    The "Caregiver Contribution to Self-Care in Ostomy Patient Index" scale consists of 22 items and 3 sub-dimensions. Scale items are evaluated with a 5-point Likert type. The first sub-dimension is "Caregiver Contribution to Self-Care Maintenance" consisting of 9 items; The second sub-dimension is "Caregiver Contribution To Self-Care Monitoring" consisting of 8 items and the third sub-dimension is " Caregiver Contribution to Self-Care Management" consisting of 5 items.

    5 months

Interventions

This study was conducted to evaluate the Turkish validity and reliability of the Caregiver Contribution to Self-Care in Ostomy Patient Index, to evaluate the relatives of patients with stoma who contribute to their self-care in Turkish society, and to contribute to the nursing literature of the measurement tool.

Eligibility Criteria

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

The research sample consisted of 223 individuals who contributed to the self-care of individuals with colostomy, ileostomy and urostomy who applied for outpatient control.

You may qualify if:

  • speaking Turkish
  • over 18 years old
  • Not having a serious psychiatric diagnosis
  • Giving written consent to participate in the study

You may not qualify if:

  • severe visual or auditory problems
  • caregivers who did not volunteer to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdag Namık Kemal University

Tekirdağ, Suleymanpasa, 59000, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 21, 2024

Study Start

September 20, 2020

Primary Completion

January 15, 2021

Study Completion

January 15, 2021

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations