Effect of Mobile Application- and AI Supported Video-Based Patient Education on Patient Outcomes in Teaching Clean Intermittent Catheterization

NCT07489261 | Not Yet Recruiting

• 1 other identifier: MU-002
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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. 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% (Hernández-Rodríguez et al., 2022), 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.

Conditions

Clean Intermittent Catheterization

Keywords

Mobile application; Artificial intelligience; Patient Outcome; Patient Education

Outcome Measures

Primary Outcomes (2)

• Adherence

  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.

  6 months

• Self-Confidence

  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.

  6 months

Study Arms (3)

Experimental Group: Mobile application group

EXPERIMENTAL

Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1)

Other: Mobile application

Experimental group: Artificial intelligent video group

EXPERIMENTAL

Patients who will perform clean intermittent catheterization will receive training through an artificial intelligence-supported educational video (intervention group 2).

Other: Artifial intellgience

Control group

NO INTERVENTION

Patients in the control group will be trained using the routine brochure provided in the outpatient clinic.

Interventions

Mobile application OTHER

Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1)

Experimental Group: Mobile application group

Artifial intellgience OTHER

Patients who will perform clean intermittent catheterization will receive training through an artificial intelligence-supported educational video (intervention group 2)

Experimental group: Artificial intelligent video group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin Unıversıty

Mersin, Turkey (Türkiye)

Location

Related Publications (5)

• Bobian, M., Kandinov, A., El Kashlan, N., Svider, P. F., Folbe, A. J., Mayerhoff, R., Eloy, J. A., & Raza, S. N. (2017). Mobile applications and patient education: Are currently available GERD mobile apps sufficient? The Laryngoscope, 127(8), 1775-1779. https://doi.org/10.1002/lary.26341

  BACKGROUND

• Cerantola, Y., Valerio, M., Persson, B., Jichlinski, P., Ljungqvist, O., Hubner, M., Kassouf, W., Müller, S., Baldini, G., Carli, F., Næsheimh, T., Ytrebø, L., Revhaug, A., Lassen, K., Knutsen, T., Aarsether, E., Wiklund, P., & Patel, H. R. (2013). Guidelines for perioperative care after radical cystectomy for bladder cancer: Enhanced Recovery After Surgery (ERAS®) society recommendations. Clinical Nutrition, 32(6), 879-887. https://doi.org/10.1016/j.clnu.2013.09.014

  RESULT

• Bhuyan, S. S., Sateesh, V., Mukul, N., Galvankar, A., Mahmood, A., Nauman, M., Rai, A., Bordoloi, K., Basu, U., & Samuel, J. (2025). Generative Artificial Intelligence Use in Healthcare: Opportunities for Clinical Excellence and Administrative Efficiency. Journal of Medical Systems, 49(1), 10. https://doi.org/10.1007/s10916-024-02136-1

  RESULT

• Hernández-Rodríguez, J. C., García-Muñoz, C., Ortiz-Álvarez, J., Saigí-Rubió, F., Conejo-Mir, J., & Pereyra-Rodriguez, J. J. (2022). Dropout Rate in Digital Health Interventions for the Prevention of Skin Cancer: Systematic Review, Meta-analysis, and Metaregression. Journal of medical Internet research, 24(12), e42397. https://doi.org/10.2196/42397

  RESULT

• Alasker, A., Alsalamah, S., Alshathri, N., Almansour, N., Alsalamah, F., Alghafees, M., AlKhamees, M., & Alsaikhan, B. (2024). Performance of large language models (LLMs) in providing prostate cancer information. BMC Urology, 24(1), 177. https://doi.org/10.1186/s12894-024-01570-0

  RESULT

Study Officials

• GAMZE BOZKUL

  Tarsus University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ELİFE KETTAŞ DÖLEK, Prinicipal İnvestigator

CONTACT

03242410000; elifeket@yahoo.com

ELİFE KETTAŞ DÖLEK, Principal İnvestigator

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study was designed as a prospective, three-arm (1:1:1), randomized controlled clinical trial

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)