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Different Levels of Patient Education for Care of Ostomy Site

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ClinicalTrials.gov Identifier: NCT02036268
Recruitment Status : Recruiting
First Posted : January 15, 2014
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Bruce W. Robb, Indiana University

Study Description
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Brief Summary:
This is a randomized study of standard versus extra ostomy education.

Condition or disease Intervention/treatment Phase
Ostomy Behavioral: Standard Behavioral: Pre-operative Education Behavioral: Two-week Post Operative Education Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : May 2012
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ostomy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard
Subjects will receive standard ostomy education.
 Behavioral: Standard
Standard ostomy education
Experimental: Pre-Operative Education
In addition to standard ostomy education, subjects will receive additional education pre-operatively.
 Behavioral: Standard
Standard ostomy education

Behavioral: Pre-operative Education
In addition to standard ostomy education, an additional pre-operative ostomy education session will be conducted with the subject.
Experimental: Two-week Post Operative Education
In addition to standard ostomy education, subjects will receive additional education two weeks following surgery.
 Behavioral: Standard
Standard ostomy education

Behavioral: Pre-operative Education
In addition to standard ostomy education, an additional pre-operative ostomy education session will be conducted with the subject.

Behavioral: Two-week Post Operative Education
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.


Outcome Measures
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Primary Outcome Measures :
  1. Quality of Life [ Time Frame: Six weeks ]
    Assessed by Stoma Quality of Life Scale and Stoma Care Self-Efficacy Scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Subjects not meeting any of the above eligibility criteria.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036268


Contacts
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Contact: Bruce W Robb, MD 317-278-6277 brobb@iupui.edu
Contact: Jean Lonergan, RN 317-688-3690 jeanlone@iupui.edu

Locations
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United States, Indiana
Indiana University Health North Hospital Recruiting
Carmel, Indiana, United States, 46032
Contact: Jean Lonergan, RN    317-688-3690    jeanlone@iupui.edu   
Principal Investigator: Bruce W Robb, MD         
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Bruce W Robb, MD Indiana University, Department of Surgery
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Bruce W. Robb, Clinical Associate Professor of Surgery, Indiana University
ClinicalTrials.gov Identifier: NCT02036268    
Other Study ID Numbers: 1202007926
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bruce W. Robb, Indiana University:
Ostomy education
Education
care of ostomy site