Internet Self-Management for People With Intermittent Urinary Catheters (Internet CIC)

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

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).

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Behavioral: teaching self-management of an intermittent catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intermittent catheter self-efficacy,	Intermittent catheter confidence related to self-care capability	pre-post 3 month intervention in a single group

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute of Nursing Research (NINR)

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: June 17, 2014
• First Submitted That Met QC Criteria: June 19, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Estimate): May 7, 2015
• Last Update Submitted That Met QC Criteria: May 6, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: self-management; self-efficacy; web-based intervention research
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 5R21NR012763-02 (U.S. NIH Grant/Contract)