Clinical trial NCT02168465: Internet Self-Management for People With Intermittent Urinary Catheters
Official title: Web-Based Self-Management Intervention for Intermittent Urinary Catheter Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: self-efficacy
self-management
web-based intervention research
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2014-06-20
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: catheter-related adverse health outcomes (e.g., UTI, urine leakage)
timeFrame: pre-post 3 month intervention in a single group
Secondary outcomes:
measure: Intermittent catheter self-efficacy,
timeFrame: pre-post 3 month intervention in a single group
Other outcomes:
measure: Intermittent catheter self-management
timeFrame: pre-post 3 month intervention in a single group
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: