Internet Self-Management for People With Intermittent Urinary Catheters (Internet CIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02168465|
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : May 7, 2015
- Design and develop web-based self-management intervention to improve catheter-related outcomes and quality of life in people with spinal cord injury (SCI).
- 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.
- Develop and test the reliability of new/modified measures (intermittent catheter self-efficacy and self-management).
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Behavioral: teaching self-management of an intermittent catheter||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Web-Based Self-Management Intervention for Intermittent Urinary Catheter Use|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
teaching self-management of intermittent catheter
Single group pre-post test of feasibility, teaching self-management
Behavioral: teaching self-management of an intermittent catheter
Specifically, we will teach awareness, self-monitoring and self-management strategies to CIC uses with SCI in an online format. Nurse telephone consultation for teaching self-management will be combined with peer leaders for online forums.
- catheter-related adverse health outcomes (e.g., UTI, urine leakage) [ Time Frame: pre-post 3 month intervention in a single group ]catheter related adverse events will be reported by internet based survey about 3 months after enrollment
- Intermittent catheter self-efficacy, [ Time Frame: pre-post 3 month intervention in a single group ]Intermittent catheter confidence related to self-care capability
- Intermittent catheter self-management [ Time Frame: pre-post 3 month intervention in a single group ]Self-care management involves specific activities performed by the person to manage their intermittent catheter.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168465
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|