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Self Management in Urinary Catheter Users

Primary Purpose

Urinary Retention, Neurogenic Bladder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Self-management of urinary catheter
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Retention focused on measuring self management, chronic condition, urinary catheter

Eligibility Criteria

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

Inclusion Criteria:

  • Have an indwelling urethral or suprapubic catheter and expect to use it for at least one year.
  • Live in Central or Western New York State (Utica to Buffalo regions approximately)OR are cared for by the Visiting Nurse Service of New York City.
  • Able to complete study measurements alone or with the help of a family member or caregiver.
  • Able to communicate with the study personnel in English.
  • Have access to a telephone for data collection.

Exclusion Criteria:

  • Terminally ill
  • Cognitively impaired
  • No catheter associated UTI within the previous 12 months NOR blockage NOR dislodgement in the previous 6 months(only in people who have had the catheter for 12 months or more)

Sites / Locations

  • Center for Home Care Policy & Research, Visiting Nurse Service of New York
  • Urinary of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-management of urinary catheter

Usual care 2

Arm Description

Intervention: Self-management group--teaching behavioral approaches(awareness, self-monitoring, and self-management) to prevent or minimize urinary catheter complications.

Usual care for urinary catheter. Home care and/or clinic care is the usual care for people with long-term urinary catheters.

Outcomes

Primary Outcome Measures

Symptomatic urinary tract infection

Secondary Outcome Measures

Urinary catheter quality of life

Full Information

First Posted
April 15, 2009
Last Updated
September 17, 2012
Sponsor
University of Rochester
Collaborators
Visiting Nurse Service of New York
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1. Study Identification

Unique Protocol Identification Number
NCT00883220
Brief Title
Self Management in Urinary Catheter Users
Official Title
Self-management of Urine Flow in Long-term Urinary Catheter Users
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Visiting Nurse Service of New York

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Learning to self-manage urine flow may help people prevent or minimize persistent complications from long-term indwelling urethral or suprapubic catheters.
Detailed Description
Urinary catheter users commonly experience adverse health effects, such as urinary tract infection (UTI), blockage, dislodgement, and leakage, leading to poor quality of life indicators. Catheter-related problems often require health care utilization resulting in increased health care costs. Self-management of urine flow is an essential part of self-care for people with long-term urinary catheters and may lead to prevention or reduction of catheter-related problems and improved quality of life.This study tests the effectiveness of a urinary catheter self-management intervention in a randomized trial of 220 patients, with 12 months of follow-up. The experimental intervention is designed to enhance self-management of urine flow in individuals with long-term urinary catheters, with the goal of decreasing catheter related complications and enhancing quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention, Neurogenic Bladder
Keywords
self management, chronic condition, urinary catheter

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-management of urinary catheter
Arm Type
Experimental
Arm Description
Intervention: Self-management group--teaching behavioral approaches(awareness, self-monitoring, and self-management) to prevent or minimize urinary catheter complications.
Arm Title
Usual care 2
Arm Type
No Intervention
Arm Description
Usual care for urinary catheter. Home care and/or clinic care is the usual care for people with long-term urinary catheters.
Intervention Type
Behavioral
Intervention Name(s)
Self-management of urinary catheter
Other Intervention Name(s)
self-management, self-monitoring, urinary catheter self care
Intervention Description
Awareness, self-monitoring, and self-management of urine flow are taught. Focus is on attaining adequate and consistent levels of fluid intake and preventing catheter dislodgement.
Primary Outcome Measure Information:
Title
Symptomatic urinary tract infection
Time Frame
every two months for 12 months
Secondary Outcome Measure Information:
Title
Urinary catheter quality of life
Time Frame
6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have an indwelling urethral or suprapubic catheter and expect to use it for at least one year. Live in Central or Western New York State (Utica to Buffalo regions approximately)OR are cared for by the Visiting Nurse Service of New York City. Able to complete study measurements alone or with the help of a family member or caregiver. Able to communicate with the study personnel in English. Have access to a telephone for data collection. Exclusion Criteria: Terminally ill Cognitively impaired No catheter associated UTI within the previous 12 months NOR blockage NOR dislodgement in the previous 6 months(only in people who have had the catheter for 12 months or more)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary H. Wilde, RN, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Home Care Policy & Research, Visiting Nurse Service of New York
City
New York City
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Urinary of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26938358
Citation
Wilde MH, Crean HF, McMahon JM, McDonald MV, Tang W, Brasch J, Fairbanks E, Shah S, Zhang F. Testing a Model of Self-Management of Fluid Intake in Community-Residing Long-term Indwelling Urinary Catheter Users. Nurs Res. 2016 Mar-Apr;65(2):97-106. doi: 10.1097/NNR.0000000000000140.
Results Reference
derived
PubMed Identifier
25502058
Citation
Wilde MH, McMahon JM, McDonald MV, Tang W, Wang W, Brasch J, Fairbanks E, Shah S, Zhang F, Chen DG. Self-management intervention for long-term indwelling urinary catheter users: randomized clinical trial. Nurs Res. 2015 Jan-Feb;64(1):24-34. doi: 10.1097/NNR.0000000000000071.
Results Reference
derived

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Self Management in Urinary Catheter Users

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