Different Levels of Patient Education for Care of Ostomy Site

Indiana University

Status: Terminated

Conditions: Ostomy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02036268

1202007926

Details and patient eligibility

About

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

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 3 patient groups

Standard

Active Comparator group

Description:

Subjects will receive standard ostomy education.

Treatment:

Behavioral: Standard

Pre-Operative Education

Experimental group

Description:

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

Treatment:

Behavioral: Standard

Behavioral: Pre-operative Education

Two-week Post Operative Education

Experimental group

Description:

In addition to standard ostomy education, subjects will receive additional education two weeks following surgery.

Treatment:

Behavioral: Standard

Behavioral: Pre-operative Education

Behavioral: Two-week Post Operative Education