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Completed

NCT Number: NCT02168465

Internet Self-Management for People With Intermittent Urinary Catheters

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • use of CIC for regular bladder drainage,
  • expect to use CIC indefinitely or for at least nine months, and
  • 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:

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

Treatment and study plan

teaching self-management of an intermittent catheter

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Intermittent catheter self-efficacy,

    Time frame: pre-post 3 month intervention in a single group

    Intermittent catheter confidence related to self-care capability

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Acronym: Internet CIC

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 20, 2014
Registry last updated
May 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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