OstomyNCT02036268
Different Levels of Patient Education for Care of Ostomy Site
A study testing Standard, Pre-operative Education and Two-week Post Operative Education in people with Ostomy, run by Indiana University at 1 site in United States.
Trial summary
This is a randomized study of standard versus extra ostomy education. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ostomy
- What is being tested?
- Standard, Pre-operative Education and Two-week Post Operative Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 12 Sep 2018
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal to or greater than 18 years of age at the time of consent.
- Scheduled to undergo surgery at IU Health North Hospital that will results in a temporary or permanent colostomy or ileostomy for a benign or malignant disease process.
- Are willing and able to provide written informed consent for participation in the study and authorization for release of health information.
- Are willing and able to attend up to two additional clinic visits at IU Health North Hospital for the purpose of ostomy teaching and care.
- Subjects who currently do NOT have a urostomy or any other type of urinary diversion and/or are NOT planning to have a urostomy or any other type of urinary diversion as part of the surgery procedures at the time of their surgery for placement of colostomy or ileostomy.
- Subjects who do NOT have any history of prior colostomy or ileostomy.
Who cannot join
- Subjects not meeting any of the above eligibility criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health North Hospital
Carmel, Indiana, 46032
About this study
Official title: A Prospective, Single-Center Study to Assess the Impact of Pre- and Post-Surgical Ostomy Care Education on Patient Outcomes and Quality of Life
This is a randomized study of standard versus extra ostomy education.
Read the detailed description
The purpose of this study is to evaluate the effectiveness of pre-operative and post-operative ostomy education compared to standard of care ostomy education.
- Conditions
- Ostomy
- Being tested
- Standard, Pre-operative Education, Two-week Post Operative Education
- Keywords
- Ostomy education, Education, care of ostomy site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StandardBehavioural
Standard ostomy education
Pre-operative EducationBehavioural
In addition to standard ostomy education, an additional pre-operative ostomy education session will be conducted with the subject.
Two-week Post Operative EducationBehavioural
In addition to standard ostomy education and an additional pre-operative ostomy education session, another ostomy education session will be conducted with the subject two weeks post-op.
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Subjects will receive standard ostomy education. Receives: Behavioral: Standard |
| Pre-Operative Education | Experimental | In addition to standard ostomy education, subjects will receive additional education pre-operatively. Receives: Behavioral: Standard; Behavioral: Pre-operative Education |
| Two-week Post Operative Education | Experimental | In addition to standard ostomy education, subjects will receive additional education two weeks following surgery. Receives: Behavioral: Standard; Behavioral: Pre-operative Education; Behavioral: Two-week Post Operative Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stoma Quality of Life Scale (SQOLS)
The SQOLS assesses patient quality of life on a 5-point Likert type scale, where 1 = Never and 5 = Always. Higher scores indicate a greater self-reported quality of life.
Measured: Six weeks
Secondary outcomes (4)
Skin integrity at the ostomy site by lesion type
Skin integrity will be assessed by the SACS Instrument (Studio Alterazioni Cutanee Stomali). The SACS classifies lesion type.
Measured: Six weeks
Skin integrity at the ostomy site by location
Skin integrity will be assessed by the SACS Instrument (Studio Alterazioni Cutanee Stomali). The SACS classifies lesion location.
Measured: Six weeks
Number of appliance changes
Subjects will be asked to record the number of wafer and/or bag changes completed during study participation in a patient diary.
Measured: Six weeks
Stoma Care Self-Efficacy Scale (SCSES)
The SCSES assesses patient quality of life on a 4-point Likert type scale, where 1 = Not At All and 5 = Almost Always. Higher scores indicate a greater self-reported quality of life related to self-confidence in stoma care.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startMay 2012
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Why it stopped: Lack of study coordinator and time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OstomyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce W. Robb, Indiana University
- Investigators
- Bruce W Robb, MD, Principal investigator, Indiana University, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036268
- Sponsor's protocol ID
- 1202007926
- Status last verified
- May 2024
- First submitted
- 13 Jan 2014
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center Study to Assess the Impact of Pre- and Post-Surgical Ostomy Care Education on Patient Outcomes and Quality of Life
- ClinicalTrials.gov ID
- NCT02036268
- Acronym / sponsor ID
- 1202007926
- Conditions
- Ostomy
- Keywords
- Ostomy education, Education, care of ostomy site
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of study coordinator and time.
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 15 Jan 2014 (estimated)
- 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 is a randomized study of standard versus extra ostomy education.
Detailed description
The purpose of this study is to evaluate the effectiveness of pre-operative and post-operative ostomy education compared to standard of care ostomy education.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Behavioral: StandardSubjects will receive standard ostomy education. |
| Pre-Operative Education | Experimental | Behavioral: Standard, Behavioral: Pre-operative EducationIn addition to standard ostomy education, subjects will receive additional education pre-operatively. |
| Two-week Post Operative Education | Experimental | Behavioral: Standard, Behavioral: Pre-operative Education, Behavioral: Two-week Post Operative EducationIn addition to standard ostomy education, subjects will receive additional education two weeks following surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age equal to or greater than 18 years of age at the time of consent.
- Scheduled to undergo surgery at IU Health North Hospital that will results in a temporary or permanent colostomy or ileostomy for a benign or malignant disease process.
- Are willing and able to provide written informed consent for participation in the study and authorization for release of health information.
- Are willing and able to attend up to two additional clinic visits at IU Health North Hospital for the purpose of ostomy teaching and care.
- Subjects who currently do NOT have a urostomy or any other type of urinary diversion and/or are NOT planning to have a urostomy or any other type of urinary diversion as part of the surgery procedures at the time of their surgery for placement of colostomy or ileostomy.
Key exclusion criteria (1 listed)
- Subjects not meeting any of the above eligibility criteria.
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 |
|---|---|---|
| StandardStandard ostomy education | Behavioural | Pre-Operative Education, Standard, Two-week Post Operative Education |
| Pre-operative EducationIn addition to standard ostomy education, an additional pre-operative ostomy education session will be conducted with the subject. | Behavioural | Pre-Operative Education, Two-week Post Operative Education |
| Two-week Post Operative EducationIn addition to standard ostomy education and an additional pre-operative ostomy education session, another ostomy education session will be conducted with the subject two weeks post-op. | Behavioural | Two-week Post Operative Education |
Primary outcome
Stoma Quality of Life Scale (SQOLS)
Time frame: Six weeks
The SQOLS assesses patient quality of life on a 5-point Likert type scale, where 1 = Never and 5 = Always. Higher scores indicate a greater self-reported quality of life.
4 secondary outcomes
Skin integrity at the ostomy site by lesion type
Time frame: Six weeks
Skin integrity at the ostomy site by location
Time frame: Six weeks
Number of appliance changes
Time frame: Six weeks
Stoma Care Self-Efficacy Scale (SCSES)
Time frame: Six weeks
Results and safety
The study was stopped early (reason given: Lack of study coordinator and time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 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.
Bruce W Robb, MD principal investigator
Indiana University, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard, Pre-operative Education and Two-week Post Operative Education in people with Ostomy, run by Indiana University at 1 site in United States.
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 6 inclusion and 1 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: stopped early, as of the sponsor's last update on 22 May 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 United States. 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 was stopped early (reason given: Lack of study coordinator and time.). 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?
Stoma Quality of Life Scale (SQOLS) (time frame: Six weeks). 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 22 May 2024.