NCT05796544

Brief Summary

The primary aim of this study is to evaluate whether remote education is as effective as in-person education in improving self-care behaviors of ostomy patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
384

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 14, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

March 3, 2023

Last Update Submit

September 14, 2023

Conditions

Ostomy

Keywords

randomized controlled trialostomytelehealth

Outcome Measures

Primary Outcomes (1)

  • Self-care maintenance

    Self-care maintenance will be measured with the Ostomy Self-care Index (OSCI). Scores range from 0 to 100, with higher scores indicating better self-care maintenance

    1 month after the last intervention

Secondary Outcomes (9)

  • Self-care monitoring

    1 month after the last intervention

  • Self-care management

    1 month after the last intervention

  • Self-care self-efficacy

    1 month after the last intervention

  • Stoma-specific quality of life

    1 month after the last intervention

  • Depression

    1 month after the last intervention

  • +4 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will receive a total of four remote educational sessions over 2 months.

Behavioral: Remote self-care education

Control group

ACTIVE COMPARATOR

The control group will receive the standard care, consisting of in-person standard education.

Behavioral: In-person self-care education

Interventions

Remote self-care educationBEHAVIORAL

The intervention group will receive a total of four remote educational sessions over 2 months.

Intervention Group
In-person self-care educationBEHAVIORAL

The active comparator group will receive a total of four in-person educational sessions over 2 months.

Control group

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • having undergone a surgical operation with subsequent ostomy placement;
  • being at least 18 years old of age;
  • absence of cognitive decline,
  • absence of any
  • being able to manage the software on the smartphone
  • be willing to participate to the trial and sign the informed consent form.

You may not qualify if:

  • presence of a cognitive decline, assessed with a score \> 4 at the Six-item Screener
  • presence of any stomal or peristomal complication
  • not being able to read and speak Italian language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Ambulatorio infermieristico per pazienti stomizzati ASL Roma2 S.Eugenio Pertini

Roma, Rome, 00144, Italy

RECRUITING

Azienda SS. Antonio e Biagio e Cesare Arrigo -

Alessandria, 15121, Italy

NOT YET RECRUITING

Istituto Tumori Pascale Napoli

Napoli, 80131, Italy

RECRUITING

Arcispedale S. Maria Nuova Azienda ospedaliera di Reggio Emilia

Reggio Emilia, 42123, Italy

RECRUITING

Tor Vergata Hospital

Roma, 00133, Italy

RECRUITING

Related Publications (4)

  • 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.

    PMID: 22739426BACKGROUND

  • 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.

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 38924038DERIVED

Study Officials

  • Ercole Vellone, Professor

    Department of Biomedicine and Prevention

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ercole Vellone, Professor

CONTACT

+390672596871ercole.vellone@uniroma2.it

Giulia Villa, PhD

CONTACT

+390226432547villa.giulia@hsr.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 3, 2023

First Posted

April 3, 2023

Study Start

June 14, 2023

Primary Completion

December 1, 2024

Study Completion

April 1, 2025

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(5)