Clean Intermittent Catheterization
Conditions
Keywords
Mobile application, Artificial intelligience, Patient Outcome, Patient Education
Brief summary
The study aimed to determine the effects of a mobile application and an artificial intelligence-supported educational video, developed for patients who will perform clean intermittent catheterization (CIC), on patients' adherence, levels of difficulty, self-confidence, infection parameters (urinalysis, urine culture, infection incidence), and recurrent hospital admissions.The number of CIC patients who applied to the Urology Outpatient Clinic of Mersin University within the last year was 110. Since no similar study was found, the sample size was calculated using an a priori power analysis with G\*Power 3.1.9.7 software. . As a result of the power analysis, the total sample size was calculated as 90, with 30 participants in each group. Considering a possible data loss (dropout) rate of approximately 10%, it was planned to include 33 participants in each group (a total of 99 participants) at the beginning of the study.Data will be collected using the "Descriptive Information Form," "Intermittent Catheterization Adherence Scale," "Self-Confidence Scale in Clean Intermittent Self-Catheterization," "Intermittent Catheterization Difficulty Questionnaire," and the "Patient Follow-up Form."Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1) and an artificial intelligence-supported educational video (intervention group 2). Patients in the control group will be trained using the routine brochure provided in the outpatient clinic.
Detailed description
The study was designed as a prospective, three-arm (1:1:1), randomized controlled clinical trial. The study will be conducted at the Urology Outpatient Clinic of Mersin University Faculty of Medicine Hospital. The Urology Outpatient Clinic includes adult and pediatric outpatient units, an intervention room, an ultrasound room, an andrology laboratory, a lithotripsy unit, and a urodynamics unit. The Department of Urology consists of seven faculty members and 11 research assistants. In the urology outpatient clinic, there is one nurse, two technicians, two secretaries, and one cleaning staff member. Outpatient services are provided between 08:00 and 17:00, and clean intermittent catheterization (CIC) training is also delivered to patients during these hours. The nurse provides training to patients who will perform CIC using a brochure. After the training, patients routinely return to the outpatient clinic for follow-up visits on the 15th day and at the 3rd month. study aimed to determine the effects of a mobile application and an artificial intelligence-supported educational video, developed for patients who will perform clean intermittent catheterization (CIC), on patients' adherence, levels of difficulty, self-confidence, infection parameters (urinalysis, urine culture, infection incidence), and recurrent hospital admissions.The number of CIC patients who applied to the Urology Outpatient Clinic of Mersin University within the last year was 110. Since no similar study was found, the sample size was calculated using an a priori power analysis with G\*Power 3.1.9.7 software. For the one-way analysis of variance (ANOVA), the parameters used were α error probability = 0.05, power (1-β error probability) = 0.80, number of groups = 3, and effect size f = 0.40 (large effect size). As a result of the power analysis, the total sample size was calculated as 90, with 30 participants in each group. Considering a possible data loss (dropout) rate of approximately 10% , it was planned to include 33 participants in each group (a total of 99 participants) at the beginning of the study.Data will be collected using the "Descriptive Information Form," "Intermittent Catheterization Adherence Scale," "Self-Confidence Scale in Clean Intermittent Self-Catheterization," "Intermittent Catheterization Difficulty Questionnaire," and the "Patient Follow-up Form."Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1) and an artificial intelligence-supported educational video (intervention group 2). Patients in the control group will be trained using the routine brochure provided in the outpatient clinic.
Interventions
OTHERMobile application
Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1)
OTHERArtifial intellgience
Patients who will perform clean intermittent catheterization will receive training through an artificial intelligence-supported educational video (intervention group 2)
Sponsors
Mersin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Patients included in the study will be assigned to groups by a researcher (GAU) who is not involved in the data collection process, using a simple randomization method based on a random numbers table. This table will be generated באמצעות the website https://www.randomizer.org.When a patient who will perform clean intermittent catheterization (CIC) presents to the outpatient clinic, the principal investigator (EKD) will evaluate the patient according to the relevant inclusion criteria. If the patient meets the criteria and signs the informed consent form, the principal investigator (EKD) will inform GAU, who will then determine and communicate the group assignment to EKD. With this method, all researchers except GAU, as well as patients, caregivers, and clinical staff, will be blinded to group assignments. To prevent bias in statistical analyses, the data of patients who have completed the data collection process will be recorded in the database by researcher MB using coded labels
Intervention model description
The study was designed as a prospective, three-arm (1:1:1), randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who require intermittent catheterization (TAK), * Aged 18 years or older, * Willing to participate in the study, * Able to understand Turkish, * Literate, * Without visual or hearing impairments, * Owning a smartphone, tablet, or computer, * Without difficulties using technology.
Exclusion criteria
* Patients who do not require intermittent catheterization (TAK), * Under 18 years of age, * Not willing to participate in the study, * Do not understand Turkish, * Illiterate, * With visual or hearing impairments, * Do not own a smartphone, tablet, or computer, * Having difficulties using technology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 6 months | The Intermittent Catheterization Adherence Scale was developed by Amandine Guinet-Lacoste and colleagues in 2018, and its Turkish adaptation and reliability study were conducted by Duman in 2021. The first seven items of the scale (except the fifth item) are scored as "Yes = 1" and "No = 0," while the fifth item is scored in reverse: "Yes = 0" and "No = 1." The eighth item uses a 5-point Likert scale, scored as "Never = 0," "Sometimes = 0.25," "Often = 0.50," "Most of the time = 0.75," and "Always = 1." The total score of the scale is calculated out of 8, with the resulting scores reflecting patients' adherence to catheterization. Accordingly, a score of 0 indicates "high adherence," 1-2 points indicate "moderate adherence," and 3-8 points indicate "low adherence." The Cronbach's alpha coefficient, indicating internal consistency of the scale, is 0.73. |
| Self-Confidence | 6 months | This scale was developed by Biaziolo and colleagues in 2017. The Turkish adaptation, validity, and reliability study was conducted by Çulha and Acaroğlu in 2020. The scale, which has a five-point Likert-type structure, consists of short statements that assess the steps of catheterization and the individual's self-confidence in performing this procedure. The response options are as follows: 1 = Not confident, 2 = Slightly confident, 3 = Confident, 4 = Very confident, 5 = Completely confident. The scale consists of a total of 16 items. The total score is calculated by summing the numerical values of the responses to all items, and the total score ranges from 0 to 64. Higher scores indicate a higher level of self-confidence in performing catheterization. The internal consistency of the scale was found to be quite high, with a total Cronbach's alpha coefficient of 0.89. |
Countries
Turkey (Türkiye)
Contacts
CONTACTELİFE KETTAŞ DÖLEK, Prinicipal İnvestigator
CONTACTELİFE KETTAŞ DÖLEK, Principal İnvestigator
PRINCIPAL_INVESTIGATORGAMZE BOZKUL
Tarsus University
Outcome results
None listed