NCT00883220

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2009

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 18, 2012

Status Verified

July 1, 2011

Enrollment Period

3 years

First QC Date

April 15, 2009

Last Update Submit

September 17, 2012

Conditions

Urinary RetentionNeurogenic Bladder

Keywords

self managementchronic conditionurinary catheter

Outcome Measures

Primary Outcomes (1)

  • Symptomatic urinary tract infection

    every two months for 12 months

Secondary Outcomes (1)

  • Urinary catheter quality of life

    6 months and 12 months

Study Arms (2)

Self-management of urinary catheter

EXPERIMENTAL

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

Behavioral: Self-management of urinary catheter

Usual care 2

NO INTERVENTION

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

Interventions

Self-management of urinary catheterBEHAVIORAL

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.

Also known as: self-management, self-monitoring, urinary catheter self care
Self-management of urinary catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

New York, New York, 10001, United States

Location

Urinary of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (2)

  • 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.

    PMID: 26938358DERIVED

  • 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.

    PMID: 25502058DERIVED

MeSH Terms

Conditions

Urinary RetentionUrinary Bladder, NeurogenicChronic Disease

Interventions

Self-ManagementBlood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesNeurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSelf-TestingSelf CareTherapeuticsInvestigative Techniques

Study Officials

  • Mary H. Wilde, RN, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 15, 2009

First Posted

April 17, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 18, 2012

Record last verified: 2011-07

Locations

US(2)