NCT04688047

Brief Summary

The aim of the study is to evaluate the effectiveness of nursing care given online to women with urinary incontinence based on the Transtheoretical (Change) Model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

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

December 21, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 22, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2021

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

December 21, 2020

Last Update Submit

March 17, 2023

Conditions

Keywords

Urinary Incontinencetranstheoretical modelmotivational interviewingnursing care

Outcome Measures

Primary Outcomes (2)

  • prevalence of urinary incontinence

    Urinary incontinence according to International Consultation on Incontinence Questionnaire - Short Form

    Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)

  • severity of urinary incontinence

    Urinary incontinence severity according to Incontinence Severity Index

    Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)

Secondary Outcomes (1)

  • Quality of life due to urinary incontinence

    Pre-interview (baseline) and last-interview 3 months after pre-interview (change from baseline at 3 months)

Study Arms (2)

Experimental

EXPERIMENTAL

Women aged 18 and over with urinary incontinence will be taken. A total of seven online interviews will be conducted with the women in the experimental group, one of which is pre-test, one is the last interview where the post-tests are applied, and five of which are motivational. Women in the experimental group were interviewed every 2 weeks and the women will be followed up by phone / mail every 2 weeks.

Behavioral: Nursing care based on the transtheoretical model

Control

NO INTERVENTION

Women aged 18 and over with urinary incontinence will be taken. A total of two online interviews will be conducted with women in the control group, one of which is a pre-test interview and one is a final interview where post-tests are applied.

Interventions

Nursing care consists of urinary incontinence training, motivational interview and telephone/mail counseling processes.

Experimental

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or above
  • Diagnosis of urinary incontinence according to the International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)
  • Mild to moderate incontinence according to the Incontinence Severity Index (ISI)
  • Having a smartphone
  • Using the WhatsApp application
  • Being at one of the stages of pre-contemplation, contemplation, preparation, and action according to the evaluation form for stages of change
  • Volunteering to participate in the study

You may not qualify if:

  • Having risk factors that are thought to affect urinary incontinence (pregnancy; giving birth within the last year; having been diagnosed with recurrent urinary tract infection; having any health problem affecting the muscle and/or nervous system; having been diagnosed with a disease that increases intra-abdominal pressure and causes coughing, such as asthma, chronic obstructive pulmonary disease; using drugs that may cause urinary incontinence, such as diuretics, anticholinergics, antidepressants, antiparkinsonian, antihistamines, sedatives, narcotic analgesics for the past year; having been diagnosed with pelvic organ prolapse; receiving education and treatment for urinary incontinence in the last year)
  • Being at the maintenance stage according to the evaluation form for stages of change
  • Not volunteering to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Family Health Centers

Kütahya, Turkey (Türkiye)

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

  • Ayten Senturk Erenel, Prof.

    Gazi University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

December 21, 2020

First Posted

December 29, 2020

Study Start

March 22, 2021

Primary Completion

September 26, 2021

Study Completion

October 28, 2021

Last Updated

March 20, 2023

Record last verified: 2023-03

Locations