EnterostomyNCT06392646
The Effect of a Postoperative Education Programme Based on Swanson's Theory of Caring on the Self-management Behavioural Competence of Elderly Enterostomal Patients
A study testing self-management education program in people with Enterostomy and Elderly, run by Wuxi No. 2 People's Hospital at 1 site in China.
Trial summary
The purpose of this intervention study was to understand the impact of a self-management education program on self-management skills, quality of life, and caregiver burden in older patients with enterostomies. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Enterostomy, Elderly, Self-management
- What is being tested?
- self-management education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2024to Jan 2025
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥60 years
- first enterostomy surgery
- informed consent to voluntarily participate in this study.
Who cannot join
- verbal communication disorder; cognitive dysfunction or history of mental illness;
- visual and manual mobility impairment unable to perform stoma care operations.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this intervention study was to understand the impact of a self-management education program on self-management skills, quality of life, and caregiver burden in older patients with enterostomies. It aims to answer the main question of whether a self-management education program can improve self-management skills, quality of life, and reduce family caregiver burden in elderly patients with enterostomies.
- Conditions
- Enterostomy, Elderly, Self-management, Education
- Being tested
- self-management education program
- Keywords
- Enterostomy, elderly, self-management, education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-management education programBehavioural
Intervention through a self-management education program constructed through evidence summarization and expert correspondence.
| Study group | Role | What they receive |
|---|---|---|
| routine care | No intervention | Taking routine care measures |
| self-management education program | Experimental | Intervention in accordance with the constructed self-management education program Receives: Behavioral: self-management education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-management
Self-management behavior questionnaire for patients with enterostomies. The questionnaire has a total score of 40-200, with higher scores being associated with better stoma self-management behaviours.
Measured: during hospitalization, approximately 5 days and post-discharge, 1month
the quality of life
City of Hope Quality of Life-ostomy Questionaire, COH-QOL-OQ. The scale has a total score of 0-320, with higher scores being associated with higher quality of life.
Measured: during hospitalization, approximately 5 days and post-discharge, 1month
Caregiver burden
Zarit Burden Interview,ZBI. The scale is scored on a total scale of 0-88, with the higher the score, the higher the burden on the carer.
Measured: during hospitalization, approximately 5 days and post-discharge, 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start20 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EnterostomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuxi No. 2 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Yan, Wuxi No. 2 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392646
- Sponsor's protocol ID
- Wuxi2PH
- Status last verified
- Jul 2024
- First submitted
- 24 Apr 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Postoperative Education Programme Based on Swanson's Theory of Caring on the Self-management Behavioural Competence of Elderly Enterostomal Patients
- ClinicalTrials.gov ID
- NCT06392646
- Acronym / sponsor ID
- Wuxi2PH
- Conditions
- Enterostomy, Elderly, Self-management, Education
- Keywords
- Enterostomy, elderly, self-management, education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Wuxi No. 2 People's HospitalUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 30 Apr 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.
The purpose of this intervention study was to understand the impact of a self-management education program on self-management skills, quality of life, and caregiver burden in older patients with enterostomies. It aims to answer the main question of whether a self-management education program can improve self-management skills, quality of life, and reduce family caregiver burden in elderly patients with enterostomies.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine care | No intervention | –Taking routine care measures |
| self-management education program | Experimental | Behavioral: self-management education programIntervention in accordance with the constructed self-management education program |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥60 years
- first enterostomy surgery
- informed consent to voluntarily participate in this study.
Key exclusion criteria (2 listed)
- verbal communication disorder; cognitive dysfunction or history of mental illness;
- visual and manual mobility impairment unable to perform stoma care operations.
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 |
|---|---|---|
| self-management education programIntervention through a self-management education program constructed through evidence summarization and expert correspondence. | Behavioural | self-management education program |
Primary outcome
self-management
Time frame: during hospitalization, approximately 5 days and post-discharge, 1month
Self-management behavior questionnaire for patients with enterostomies. The questionnaire has a total score of 40-200, with higher scores being associated with better stoma self-management behaviours.
the quality of life
Time frame: during hospitalization, approximately 5 days and post-discharge, 1month
City of Hope Quality of Life-ostomy Questionaire, COH-QOL-OQ. The scale has a total score of 0-320, with higher scores being associated with higher quality of life.
Caregiver burden
Time frame: during hospitalization, approximately 5 days and post-discharge, 1month
Zarit Burden Interview,ZBI. The scale is scored on a total scale of 0-88, with the higher the score, the higher the burden on the carer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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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?
A study testing self-management education program in people with Enterostomy and Elderly, run by Wuxi No. 2 People's Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 30 Jul 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 China. 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?
Results are not available in the source record.
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?
self-management (time frame: during hospitalization, approximately 5 days and post-discharge, 1month). The study lists 3 primary outcomes in all. 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 30 Jul 2024.