Internet Self-Management for People With Intermittent Urinary Catheters

Spinal Cord Injury Clinical Trial

— Internet CIC  

Official title:

Web-Based Self-Management Intervention for Intermittent Urinary Catheter Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02168465
• Other study ID #: 5R21NR012763-02
• Secondary ID: 5R21NR012763-02
• Status: Completed
• Phase: N/A
• First received: June 17, 2014
• Last updated: May 6, 2015
• Start date: June 2013
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:Individuals will be included if they are English speaking adults over 18 years with an SCI and are interested in participating. Inclusion criteria are:

1. use of CIC for regular bladder drainage,

2. expect to use CIC indefinitely or for at least nine months, and

3. access to and ability to use a computer and telephone. Computer and telephone use may be voice activated for those with little hand use. Study participants do not need to perform CIC entirely themselves, as people with limited hand dexterity may have caregivers who do the procedure. They do need to be able to use the computer and telephone however.

Additional inclusion criteria for the five persons in the "intervention and pretesting group" (described below in III, 1) include:

1. having used CIC for regular bladder drainage for at least one year and

2. expect to use CIC indefinitely or for at least one more year. People will need to have used CIC for at least a year so that they are well experienced in CIC because the two Peer Leaders will be selected from this group.

Exclusion Criteria:

• People will be excluded if they cannot communicate in English,

• Are terminally ill, or are expected to discontinue CIC within the next nine months. - Non-English speaking people will not be included because translated instruments (e.g., Spanish) are not available for all measures and doing this as a part of this small study might compromise the integrity of this first test of preliminary effectiveness.

Study Design

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intermittent catheter self-management	Self-care management involves specific activities performed by the person to manage their intermittent catheter.	pre-post 3 month intervention in a single group	No
Primary	catheter-related adverse health outcomes (e.g., UTI, urine leakage)	catheter related adverse events will be reported by internet based survey about 3 months after enrollment	pre-post 3 month intervention in a single group	Yes
Secondary	Intermittent catheter self-efficacy,	Intermittent catheter confidence related to self-care capability	pre-post 3 month intervention in a single group	No

External Links

•   Study recruitment site with description of study, including consent form