Different Levels of Patient Education for Care of Ostomy Site

NCT02036268 | Terminated DMC

• 1 other identifier: 1202007926
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ostomy

Keywords

Ostomy education; Education; care of ostomy site

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Skin integrity at the ostomy site by lesion type

  Six weeks

• Skin integrity at the ostomy site by location

  Six weeks

• Number of appliance changes

  Six weeks

• Stoma Care Self-Efficacy Scale (SCSES)

  Six weeks

Study Arms (3)

Standard

ACTIVE COMPARATOR

Subjects will receive standard ostomy education.

Behavioral: Standard

Pre-Operative Education

EXPERIMENTAL

In addition to standard ostomy education, subjects will receive additional education pre-operatively.

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.

Behavioral: Standard; Behavioral: Pre-operative Education; Behavioral: Two-week Post Operative Education

Interventions

Standard BEHAVIORAL

Standard ostomy education

Pre-Operative Education; Standard; Two-week Post Operative Education

Pre-operative Education BEHAVIORAL

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

Pre-Operative Education; Two-week Post Operative Education

Two-week Post Operative Education BEHAVIORAL

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.

Two-week Post Operative Education

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects not meeting any of the above eligibility criteria.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health North Hospital

Carmel, Indiana, 46032, United States

Location

Study Officials

• Bruce W Robb, MD

  Indiana University, Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Surgery

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 15, 2014
• Study Start: May 1, 2012
• Primary Completion: September 12, 2018
• Study Completion: September 12, 2018
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)