Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:51 AM
Study NCT ID:
NCT07489261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Mobile Application- and AI Supported Video-Based Patient Education on Patient Outcomes in Teaching Clean Intermittent Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study was designed as a prospective, three-arm (1:1:1), randomized controlled clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 99}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-19', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Self-Confidence', 'timeFrame': '6 months', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mobile application', 'Artificial intelligience', 'Patient Outcome', 'Patient Education'], 'conditions': ['Clean Intermittent Catheterization']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}, {'type': 'RESULT', 'citation': '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'}, {'type': 'RESULT', 'citation': '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'}, {'type': 'RESULT', 'citation': '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'}, {'type': 'RESULT', 'citation': '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'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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% (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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who require intermittent catheterization (TAK),\n* Aged 18 years or older,\n* Willing to participate in the study,\n* Able to understand Turkish,\n* Literate,\n* Without visual or hearing impairments,\n* Owning a smartphone, tablet, or computer,\n* Without difficulties using technology.\n\nExclusion Criteria:\n\n* Patients who do not require intermittent catheterization (TAK),\n* Under 18 years of age,\n* Not willing to participate in the study,\n* Do not understand Turkish,\n* Illiterate,\n* With visual or hearing impairments,\n* Do not own a smartphone, tablet, or computer,\n* Having difficulties using technology.'}, 'identificationModule': {'nctId': 'NCT07489261', 'briefTitle': 'Effect of Mobile Application- and AI Supported Video-Based Patient Education on Patient Outcomes in Teaching Clean Intermittent Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Mersin University'}, 'officialTitle': 'Effect of Mobile Application- and Artificial Intelligence-Supported Video-Based Patient Education on Patient Outcomes in Teaching Clean Intermittent Catheterization', 'orgStudyIdInfo': {'id': 'MU-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group: Mobile application group', 'description': 'Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1)', 'interventionNames': ['Other: Mobile application']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group: Artificial intelligent video group', 'description': 'Patients who will perform clean intermittent catheterization will receive training through an artificial intelligence-supported educational video (intervention group 2).', 'interventionNames': ['Other: Artifial intellgience']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients in the control group will be trained using the routine brochure provided in the outpatient clinic.'}], 'interventions': [{'name': 'Mobile application', 'type': 'OTHER', 'description': 'Patients who will perform clean intermittent catheterization will receive training through a mobile application (intervention group 1)', 'armGroupLabels': ['Experimental Group: Mobile application group']}, {'name': 'Artifial intellgience', 'type': 'OTHER', 'description': 'Patients who will perform clean intermittent catheterization will receive training through an artificial intelligence-supported educational video (intervention group 2)', 'armGroupLabels': ['Experimental group: Artificial intelligent video group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mersin', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'GAMZE BOZKUL', 'role': 'CONTACT', 'email': 'gamze.bozkul@gmail.com'}, {'name': 'Elife Kettaş dölek', 'role': 'CONTACT', 'email': 'elifeket@yahoo.com'}, {'name': 'GÜLAY ALTUN UĞRAŞ', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'ERİM ERDEM', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'MERT BAŞARANOĞLU', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mersin Unıversıty', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'centralContacts': [{'name': 'ELİFE KETTAŞ DÖLEK, Prinicipal İnvestigator', 'role': 'CONTACT', 'email': 'elifeket@yahoo.com', 'phone': '03242410000'}, {'name': 'ELİFE KETTAŞ DÖLEK, Principal İnvestigator', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'GAMZE BOZKUL', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tarsus University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mersin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elife Kettas Dolek', 'investigatorAffiliation': 'Mersin University'}}}}