Different Levels of Patient Education for Care of Ostomy Site

May 20, 2024 updated by: Bruce W. Robb, Indiana University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Indiana University Health North Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin integrity at the ostomy site by lesion type
Time Frame: Six weeks
Skin integrity will be assessed by the SACS Instrument (Studio Alterazioni Cutanee Stomali). The SACS classifies lesion type.
Six weeks
Skin integrity at the ostomy site by location
Time Frame: Six weeks
Skin integrity will be assessed by the SACS Instrument (Studio Alterazioni Cutanee Stomali). The SACS classifies lesion location.
Six weeks
Number of appliance changes
Time Frame: Six weeks
Subjects will be asked to record the number of wafer and/or bag changes completed during study participation in a patient diary.
Six weeks
Stoma Care Self-Efficacy Scale (SCSES)
Time Frame: Six weeks
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.
Six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Bruce W Robb, MD, Indiana University, Department of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

September 12, 2018

Study Completion (Actual)

September 12, 2018

Study Registration Dates

First Submitted

January 13, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimated)

January 15, 2014

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 20, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1202007926

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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