NCT03030144

Brief Summary

The international literature emphasizes the vast benefits of the effective implementation of evidence based nursing recommendations in improving patient care processes and enhancing health outcomes. The key role of nurses in the prevention, treatment and care of incontinence is highlighted. Studies have shown that UI is a neglected nursing care problem in Austria e.g. regarding diagnosis and nursing interventions. Nursing recommendations may enhance the frequency of diagnosis, the use of nursing interventions as well as decrease the frequency of daily UI in nursing home residents. Beside that little is known about nursing recommendations implementation regarding urinary incontinence in the nursing home setting, especially in the Austrian context. The aim of this study is to measure the effectiveness of the implementation of evidence based nursing recommendations regarding UI in Austrian nursing homes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

April 18, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

January 12, 2017

Last Update Submit

May 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference of the frequency of daily urinary incontinence between intervention and control group

    Collected after 3 Month

    3 month

Secondary Outcomes (2)

  • Difference of nurses diagnoses for urinary incontinence between intervention and control group

    3 Month

  • Difference between the intervention and control group in the use of nursing interventions

    3 Month

Study Arms (2)

Control group

NO INTERVENTION

Routine nursing care

Intervention group

OTHER

Evidence based nursing recommendations for the management of urinary incontinence will be introduced.

Other: Evidence based nursing recommendations

Interventions

The intervention group gets the evidence based nursing interventions for the conservative management of urinary incontinence in female nursing homes.

Intervention group

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. The management of the institution agrees to the random allocation to the intervention or control group.
  • \. A clinical guideline including evidence based nursing recommendations related to UI has not been introduced and implemented.
  • \. Nursing staff have not received a specialized training in the last 2 years on UI prevention or management.
  • \. Less than 5 other major nursing care innovation projects have been implemented during the last two years.
  • \. Within the institution there is no specialized nurse employed for the management of incontinence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nursing Science

Graz, Styria, 8010, Austria

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Manuela Hoedl, BSc, MSc

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 24, 2017

Study Start

April 18, 2017

Primary Completion

October 2, 2017

Study Completion

February 1, 2018

Last Updated

May 24, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations