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P-INC: Project Incontinence- Effectiveness of Nursing Recommendations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030144
Recruitment Status : Completed
First Posted : January 24, 2017
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

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.


Condition or disease Intervention/treatment Phase
Urinary Incontinence Other: Evidence based nursing recommendations Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Nursing Recommendations for the Management of Urinary Incontinence in Nursing Homes: a Cluster-randomized Controlled Trial
Actual Study Start Date : April 18, 2017
Actual Primary Completion Date : October 2, 2017
Actual Study Completion Date : February 1, 2018

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Arm Intervention/treatment
No Intervention: Control group
Routine nursing care
Intervention group
Evidence based nursing recommendations for the management of urinary incontinence will be introduced.
Other: Evidence based nursing recommendations
The intervention group gets the evidence based nursing interventions for the conservative management of urinary incontinence in female nursing homes.




Primary Outcome Measures :
  1. Difference of the frequency of daily urinary incontinence between intervention and control group [ Time Frame: 3 month ]
    Collected after 3 Month


Secondary Outcome Measures :
  1. Difference of nurses diagnoses for urinary incontinence between intervention and control group [ Time Frame: 3 Month ]
    Collected after 3 Month

  2. Difference between the intervention and control group in the use of nursing interventions [ Time Frame: 3 Month ]
    Collected after 3 Month



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. The management of the institution agrees to the random allocation to the intervention or control group.

    2. A clinical guideline including evidence based nursing recommendations related to UI has not been introduced and implemented.

    3. Nursing staff have not received a specialized training in the last 2 years on UI prevention or management.

    4. Less than 5 other major nursing care innovation projects have been implemented during the last two years.

    5. Within the institution there is no specialized nurse employed for the management of incontinence.

Inclusion criteria for nursing home residents are living in the nursing home at the date of baseline measurement and being female and assumed to stay for the whole duration of the study (3 months).

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030144


Locations
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Austria
Institute of Nursing Science
Graz, Styria, Austria, 8010
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Manuela Hoedl, BSc, MSc Medical University of Graz
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03030144    
Other Study ID Numbers: 29-007 ex 16/17
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders