Different Levels of Patient Education for Care of Ostomy Site

NCT ID: NCT02036268

Last Updated: 2024-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2018-09-12

Brief Summary

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

Detailed Description

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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.

Conditions

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Ostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard

Subjects will receive standard ostomy education.

Group Type ACTIVE_COMPARATOR

Standard

Intervention Type BEHAVIORAL

Standard ostomy education

Pre-Operative Education

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

Group Type EXPERIMENTAL

Standard

Intervention Type BEHAVIORAL

Standard ostomy education

Pre-operative Education

Intervention Type BEHAVIORAL

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, subjects will receive additional education two weeks following surgery.

Group Type EXPERIMENTAL

Standard

Intervention Type BEHAVIORAL

Standard ostomy education

Pre-operative Education

Intervention Type BEHAVIORAL

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

Two-week Post Operative Education

Intervention Type 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.

Interventions

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Standard

Standard ostomy education

Intervention Type BEHAVIORAL

Pre-operative Education

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Bruce W. Robb

Clinical Associate Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce W Robb, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University, Department of Surgery

Locations

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Indiana University Health North Hospital

Carmel, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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1202007926

Identifier Type: -

Identifier Source: org_study_id

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