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Clinical Trial Summary

1. Design and develop web-based self-management intervention to improve catheter-related outcomes and quality of life in people with spinal cord injury (SCI).

2. Conduct a pilot study to assess the feasibility (i.e., acceptability and usability of the website application) and preliminary effectiveness of this new self-management intervention.

3. Develop and test the reliability of new/modified measures (intermittent catheter self-efficacy and self-management).


Clinical Trial Description

Stages involve: (1) Develop an Internet-based intervention to improve self-management and outcomes related to clean intermittent catheterization (CIC) among people with SCI (2) Pretest the Internet application with five persons with SCI using CIC; and (3) Conduct a web-based six-month intervention pilot study in a group of 30 with SCI using CIC.

Outcomes are: catheter-related adverse health outcomes (e.g., UTI, urine leakage), CIC self- management, CIC self-efficacy, health related expenditures and quality of life.

Information from this study will be used to modify the Internet application for a future Phase 2 trial in a larger study. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT02168465
Study type Interventional
Source University of Rochester
Contact
Status Completed
Phase N/A
Start date June 2013
Completion date February 2015

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