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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
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Mary Wilde, University of Rochester

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).

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Behavioral: teaching self-management of an intermittent catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute of Nursing Research (NINR)
Additional Information:
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Responsible Party: Mary Wilde, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT02168465    
Other Study ID Numbers: 5R21NR012763-02 ( U.S. NIH Grant/Contract )
5R21NR012763-02 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: May 7, 2015
Last Verified: May 2015
Keywords provided by Mary Wilde, University of Rochester:
self-efficacy
self-management
web-based intervention research
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries