Self Management in Urinary Catheter Users

NCT ID: NCT00883220

Last Updated: 2012-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-06-30

Brief Summary

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Learning to self-manage urine flow may help people prevent or minimize persistent complications from long-term indwelling urethral or suprapubic catheters.

Detailed Description

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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.

Conditions

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Urinary Retention Neurogenic Bladder

Keywords

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self management chronic condition urinary catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Self-management of urinary catheter

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

Group Type EXPERIMENTAL

Self-management of urinary catheter

Intervention Type BEHAVIORAL

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.

Usual care 2

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Self-management of urinary catheter

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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self-management self-monitoring urinary catheter self care

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Visiting Nurse Service of New York

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Mary Wilde

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary H. Wilde, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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

New York, New York, United States

Site Status

Urinary of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26938358 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25502058 (View on PubMed)

Other Identifiers

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1R01NR010553-01

Identifier Type: NIH

Identifier Source: secondary_id

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1R01NR010553-01

Identifier Type: NIH

Identifier Source: org_study_id

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