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

Primary Purpose

Spinal Cord Injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

teaching self-management of an intermittent catheter

About this trial

This is an interventional prevention trial for Spinal Cord Injury focused on measuring self-efficacy, self-management, web-based intervention research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Rochester

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

teaching self-management of intermittent catheter

Arm Description

Single group pre-post test of feasibility, teaching self-management

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intermittent catheter self-efficacy,

Intermittent catheter confidence related to self-care capability

Full Information

NCT ID

NCT02168465

First Posted

June 17, 2014

Last Updated

May 6, 2015

Sponsor

University of Rochester

Collaborators

National Institute of Nursing Research (NINR)

1. Study Identification

Unique Protocol Identification Number

NCT02168465

Brief Title

Internet Self-Management for People With Intermittent Urinary Catheters

Acronym

Internet CIC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Design and develop web-based self-management intervention to improve catheter-related outcomes and quality of life in people with spinal cord injury (SCI). 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury

Keywords

self-efficacy, self-management, web-based intervention research

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

teaching self-management of intermittent catheter

Arm Type

Other

Arm Description

Single group pre-post test of feasibility, teaching self-management

Intervention Type

Behavioral

Intervention Name(s)

teaching self-management of an intermittent catheter

Intervention Description

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 Measure Information:

Title

catheter-related adverse health outcomes (e.g., UTI, urine leakage)

Description

catheter related adverse events will be reported by internet based survey about 3 months after enrollment

Time Frame

pre-post 3 month intervention in a single group

Secondary Outcome Measure Information:

Title

Intermittent catheter self-efficacy,

Description

Intermittent catheter confidence related to self-care capability

Time Frame

pre-post 3 month intervention in a single group

Other Pre-specified Outcome Measures:

Title

Intermittent catheter self-management

Description

Self-care management involves specific activities performed by the person to manage their intermittent catheter.

Time Frame

pre-post 3 month intervention in a single group

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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.

Facility Information:

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

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Internet Self-Management for People With Intermittent Urinary Catheters

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