Internet Self-Management for People With Intermittent Urinary Catheters

NCT02168465 | Completed DMC

• 1 other identifier: 5R21NR012763-02
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.Develop and test the reliability of new/modified measures (intermittent catheter self-efficacy and self-management).

Conditions

Spinal Cord Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intermittent catheter self-efficacy,

  pre-post 3 month intervention in a single group

Other Outcomes (1)

• Intermittent catheter self-management

  pre-post 3 month intervention in a single group

Study Arms (1)

teaching self-management of intermittent catheter

OTHER

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

Behavioral: teaching self-management of an intermittent catheter

Interventions

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.

teaching self-management of intermittent catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 20, 2014
• Study Start: June 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 7, 2015

Record last verified: 2015-05

Locations

US (1)