The Effect of Incontinence Program Applied to Obese Elderly on Quality of Life, Coping and Loneliness
The Effect of Urinary Incontinence Management Program in Obese Elderly on Quality of Life, 'Coping With Incontinence' and Loneliness
1 other identifier
interventional
60
1 country
1
Brief Summary
The goal of this: It was planned in a single-blind randomized controlled pre-test-post-test experimental research design. The aim of this study is to determine the effect of urinary incontinence management program on quality of life, coping with incontinence and loneliness in obese elderly. The main questions it aims to answer are: Does the Urinary Incontinence Management Program prepared for the obese elderly affect the quality of life, coping with incontinence and loneliness levels of the elderly in the experimental and control groups? After the Urinary Incontinence Management Program prepared for the obese elderly, is there an increase in the incontinence quality of life of the obese elderly in the experimental group compared to the obese elderly in the control group? After the Urinary Incontinence Management Program prepared for the obese elderly, is there an increase in the level of coping with incontinence of the obese elderly in the experimental group compared to the obese elderly in the control group? After the Urinary Incontinence Management Program prepared for the obese elderly, is there a decrease in the loneliness levels of the obese elderly in the experimental group compared to the obese elderly in the control group? After the Urinary Incontinence Management Program prepared for the obese elderly, is there an increase in the incontinence quality of life, coping with incontinence and loneliness levels of the elderly in the experimental group after the intervention compared to the pre-intervention?
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 Jul 2023
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
March 6, 2023
CompletedFirst Posted
Study publicly available on registry
June 7, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJune 7, 2023
June 1, 2023
1 month
March 6, 2023
June 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Incontinence Quality of Life - I-QOL Scale
The incontinence quality of life scale was developed by Wagner et al. in the USA in 1996 to determine the quality of life in patients with urinary incontinence. The validity and reliability of I-QOL in our country was done by Özerdoğan (2003). It has three sub-areas: limitation of behavior, psychosocial influence, and social isolation. In the Incontinence Quality of Life Scale (I-QOL), all items are evaluated on a five-point Likert-type scale as 1=a lot, 2=a lot, 3=moderate, 4=somewhat, 5=not at all. A maximum of 110 points can be obtained from the overall scale, 40 points from the behavior limitation sub-dimension, 45 points from the psychosocial impact sub-dimension, and 25 points from the social isolation sub-dimension. High scores indicate better quality of life than low scores.
Time Frame: 17 weeks
Incontinence Awareness and Attitude Scale
The scale was developed by Avcı et al in 2017. The answers given to each statement in the scale are in the form of strongly agree, agree, undecided, disagree, strongly disagree, and the scale is in a 5-point Likert type. The scale does not have a total score. For the sub-dimension of coping with urinary incontinence, a minimum of 6 and a maximum of 30 are taken. In this study, only the coping with urinary incontinence sub-dimension of this scale will be used.
Time Frame: 17 weeks
Urogenital distress inventory
The Turkish validity study of the urogenital distress inventory (UDI) was performed by Çam et al (2007). The scale is an inquiry form used to measure the presence of lower urinary tract symptoms and the degree of distress. UDI-6 consists of six questions and is graded on a four-point Likert scale. The first two questions are aimed at revealing irritative symptoms (urgency, frequency and pain), while the 3rd and 4th questions are aimed at stress symptoms, and the last two questions are for obstructive or voiding symptoms. Six questions ask about frequent urination, leakage due to a sense of urgency, leakage related to activity, coughing or sneezing, a small amount of leakage, difficulty in emptying the bladder, and pain or discomfort in the lower abdomen or genital area.
Time Frame: 17 weeks
Health Belief Scale for Urinary Incontinence and Kegel Exercise:
The scale was developed by Avcı and Yıldırım (2019) based on the health belief model to determine individuals' beliefs about urinary incontinence and kegel exercises. The scale consists of 49 questions in 5-point Likert type and 6 sub-dimensions. The scale does not have a total score. In this study, this scale; Kegel exercise perception of benefit sub-dimension, kegel exercise disability perception sub-dimension and self-efficacy sub-dimension will be used. The scores obtained from the sub-dimensions and sub-dimensions of the scale are as follows: between 7-35 points for the perception of benefit sub-dimension of kegel exercise; Kegel exercise varies between 9-45 points for the perception of disability sub-dimension and between 5-25 points for the self-efficacy sub-dimension. Higher scores indicate that benefits are perceived as high for the perception of benefit, and obstacles are perceived as high for the perception of obstacles.
Time Frame: 17 weeks
Loneliness Scale for the Elderly:
The scale was developed by de Jong Gierveld and Kamphuis in 1985 and revised by de Jong Gierveld and van Tilburg in 1999. The Turkish validity-reliability study of the scale was carried out by Akgül and Yeşilyaprak (2015). The scale, which has 11 questions in total, consists of 2 sub-dimensions. 6 items (2,3,5,6,9,10) of the scale consist of negative statements measuring emotional loneliness, and 5 items (1,4,7,8,11) consist of positive statements that measure social loneliness. The extent to which the situation contained in each statement in the scale is experienced by the person is determined by a 3-point Likert type rating. The rating is 0= yes, 1= maybe, 2= no. The lowest score on the scale is 0, and the highest score is 22. Total loneliness can be divided into four levels: Level 1; not alone / does not feel lonely (score 0-4); Level 2; acceptable loneliness (5-14 points); Level 3; very lonely (15-18 points); Level 4; It is very intense loneliness (score 19-22).
Time Frame: 17 weeks
Secondary Outcomes (1)
Body Mass İndex Measurement (Weıght and Heıght) (Time Frame: 17 Weeks)
17 weeks
Study Arms (2)
experimental:educt
EXPERIMENTALTraining on improving the quality of life, coping with incontinence and kegel exercises will be given to obese elderly people over 65 years of age with urinary incontinence in the experimental group. Face-to-face training will be given to the elderly in the experimental group for a total of 5 weeks, once a week day (60 minutes). In the 4th week, reminder messages will be started over the phone. The 4th week kegel exercise chart and nutrition list will be given. In the 5th week, kegel exercise dance will be watched. Sending reminder messages from the phone will continue for 3 months.
active comparator, control group
NO INTERVENTIONThe elderly in the control group will not be interfered with.
Interventions
Face-to-face training will be given to the elderly in the experimental group for a total of 5 weeks, once a week day (60 minutes). In the 4th week, reminder messages will be started over the phone. The 4th week kegel exercise chart and nutrition list will be given. In the 5th week, kegel exercise dance will be watched. Sending reminder messages from the phone will continue for 3 months.
Eligibility Criteria
You may qualify if:
- Standardized Mini Mental Test (SMMT) total score of 24 and above,
- ≥ BMI ≥ 34.9 (obesity class 1) obese,
- years and older,
- Those experiencing stress or urge urinary incontinence,
- Able to use smart mobile phone, use Whatsapp application,
- Those who do not have a health problem that prevents them from doing Kegel exercises.
You may not qualify if:
- Those with a history of incontinence surgery,
- Those who are morbidly obese,
- Having neurological and psychiatric disease,
- with pelvic organ prolapse,
- Having a disease affecting the genital and urinary system,
- those who cannot be communication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sinop Family Health Center No. 1
Sinop, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
İlknur Aydın Avci, professor
Ondokuz Mayıs University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- research assistant
Study Record Dates
First Submitted
March 6, 2023
First Posted
June 7, 2023
Study Start
July 1, 2023
Primary Completion
August 1, 2023
Study Completion
December 1, 2023
Last Updated
June 7, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share