Urinary Incontinence and Transtheoretical Model
1 other identifier
interventional
59
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
December 29, 2020
CompletedStudy Start
First participant enrolled
March 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2021
CompletedMarch 20, 2023
March 1, 2023
6 months
December 21, 2020
March 17, 2023
Conditions
Keywords
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
EXPERIMENTALWomen 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.
Control
NO INTERVENTIONWomen 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.
Eligibility Criteria
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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ayten Senturk Erenel, Prof.
Gazi University
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