Stoma ColostomyNCT06269276
Caregiver Contribution to Self-Care in Ostomy Patient Index: Turkish Validity and Reliability Study
An observational study of Stoma Colostomy and Stoma Ileostomy, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stoma Colostomy, Stoma Ileostomy, Caregiver
- What is being tested?
- Caregiver Contribution to Self-Care in Ostomy Patient Index
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 223 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2020to 15 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- speaking Turkish
- over 18 years old
- Not having a serious psychiatric diagnosis
- Giving written consent to participate in the study
Who cannot join
- severe visual or auditory problems
- caregivers who did not volunteer to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tekirdag Namık Kemal University
Tekirdağ, Suleymanpasa, 59000
About this study
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.
Read the detailed description
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. The 18th item of the scale, which evaluates the state of experiencing complications, has a low factor load and was accepted as an add-on. The highest 110 points are obtained from the scale, and it is stated that as the total score from the scale increases, self-care also increases.
- Conditions
- Stoma Colostomy, Stoma Ileostomy, Caregiver, Self Care
- Being tested
- Caregiver Contribution to Self-Care in Ostomy Patient Index
- Keywords
- caregiver, stoma, self care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver Contribution to Self-Care in Ostomy Patient IndexBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start20 Sep 2020
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma ColostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülin YILDIZ, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269276
- Sponsor's protocol ID
- CAVCU
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Contribution to Self-Care in Ostomy Patient Index: Turkish Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT06269276
- Acronym / sponsor ID
- CAVCU
- Conditions
- Stoma Colostomy, Stoma Ileostomy, Caregiver, Self Care
- Keywords
- caregiver, stoma, self care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The 18th item of the scale, which evaluates the state of experiencing complications, has a low factor load and was accepted as an add-on. The highest 110 points are obtained from the scale, and it is stated that as the total score from the scale increases, self-care also increases.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- speaking Turkish
- over 18 years old
- Not having a serious psychiatric diagnosis
- Giving written consent to participate in the study
Key exclusion criteria (2 listed)
- severe visual or auditory problems
- caregivers who did not volunteer to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caregiver Contribution to Self-Care in Ostomy Patient IndexThis 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. | Behavioural | – |
Primary outcome
Caregiver Contribution to Self-Care in Ostomy Patient Index
Time frame: 5 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stoma Colostomy and Stoma Ileostomy, run by Namik Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Contribution to Self-Care in Ostomy Patient Index (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.