Different Levels of Patient Education for Care of Ostomy Site

N/ATerminatedNCT02036268

Indiana University53 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Ostomy

Interventions

StandardBEHAVIORAL

Standard ostomy education

Pre-operative EducationBEHAVIORAL

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

Two-week Post Operative EducationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Indiana University Health North Hospital

Carmel, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: Six weeks

Secondary Outcomes

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.

Time frame: Six weeks

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.

Time frame: Six weeks

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.

Time frame: Six weeks

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.

Time frame: Six weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.