Different Levels of Patient Education for Care of Ostomy Site

Ostomy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02036268
• Other study ID #: 1202007926
• Status: Terminated
• Phase: N/A
• Start date: May 2012
• Est. completion date: September 12, 2018

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized study of standard versus extra ostomy education.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: September 12, 2018
• Est. primary completion date: September 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ostomy

Intervention

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

Locations

Country	Name	City	State
United States	Indiana University Health North Hospital	Carmel	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Six weeks
Secondary	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.	Six weeks
Secondary	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.	Six weeks
Secondary	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.	Six weeks
Secondary	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.	Six weeks