Effectiveness of Remote Self-care Education for Ostomy Patients
NCT ID: NCT05796544
Last Updated: 2023-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
384 participants
INTERVENTIONAL
2023-06-14
2025-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Intervention Group
The intervention group will receive a total of four remote educational sessions over 2 months.
Remote self-care education
The intervention group will receive a total of four remote educational sessions over 2 months.
Control group
The control group will receive the standard care, consisting of in-person standard education.
In-person self-care education
The active comparator group will receive a total of four in-person educational sessions over 2 months.
Interventions
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Remote self-care education
The intervention group will receive a total of four remote educational sessions over 2 months.
In-person self-care education
The active comparator group will receive a total of four in-person educational sessions over 2 months.
Eligibility Criteria
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Inclusion Criteria
2. being at least 18 years old of age;
3. absence of cognitive decline,
4. absence of any
5. being able to manage the software on the smartphone
6. be willing to participate to the trial and sign the informed consent form.
Exclusion Criteria
2. presence of any stomal or peristomal complication
3. not being able to read and speak Italian language
18 Years
120 Years
ALL
No
Sponsors
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University of Rome Tor Vergata
OTHER
Responsible Party
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Ercole Vellone
Associate Professor
Principal Investigators
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Ercole Vellone, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Biomedicine and Prevention
Locations
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Ambulatorio infermieristico per pazienti stomizzati ASL Roma2 S.Eugenio Pertini
Roma, Rome, Italy
Azienda SS. Antonio e Biagio e Cesare Arrigo -
Alessandria, , Italy
Istituto Tumori Pascale Napoli
Napoli, , Italy
Arcispedale S. Maria Nuova Azienda ospedaliera di Reggio Emilia
Reggio Emilia, , Italy
Tor Vergata Hospital
Roma, , Italy
Countries
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Central Contacts
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References
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Riegel B, Jaarsma T, Stromberg A. A middle-range theory of self-care of chronic illness. ANS Adv Nurs Sci. 2012 Jul-Sep;35(3):194-204. doi: 10.1097/ANS.0b013e318261b1ba.
2. Villa, G., Vellone, E., Sciara, S., Stievano, A., Proietti, M. G., Manara, D. F., ... & Pantaleo, G. (2019). Two new tools for self-care in ostomy patients and their informal caregivers: Psychosocial, clinical, and operative aspects. International Journal of Urological Nursing, 13(1), 23-30.
Costa, A., Maria, M., Campos, C., & Santos, J. D. (2020). Effect of educational intervention in postoperative people with intestinal elimination stomies: systematic review. doi:10.6018/eglobal.19.1.368501
Iovino P, Vellone E, Campoli A, Tufano C, Esposito MR, Guberti M, Bolgeo T, Sandroni C, Sili A, Manara DF, Alvaro R, Rasero L, Villa G. Telehealth vs in-person education for enhancing self-care of ostomy patients (Self-Stoma): Protocol for a noninferiority, randomized, open-label, controlled trial. PLoS One. 2024 Jun 26;19(6):e0303015. doi: 10.1371/journal.pone.0303015. eCollection 2024.
Other Identifiers
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N.119.22
Identifier Type: -
Identifier Source: org_study_id
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