OstomySELF-STOMANCT05796544
Effectiveness of Remote Self-care Education for Ostomy Patients
A study testing Remote self-care education and In-person self-care education in people with Ostomy, run by University of Rome Tor Vergata at 5 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Ostomy
- What is being tested?
- Remote self-care education and In-person self-care education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 5 sitesItaly
- Study dates
- 14 Jun 2023to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Not yet recruiting
Azienda SS. Antonio e Biagio e Cesare Arrigo -
Alessandria, 15121
- Recruiting
Istituto Tumori Pascale Napoli
Naples, 80131
- Recruiting
Arcispedale S. Maria Nuova Azienda ospedaliera di Reggio Emilia
Reggio Emilia, 42123
- Recruiting
Ambulatorio infermieristico per pazienti stomizzati ASL Roma2 S.Eugenio Pertini
Roma, Rome, 00144
- Recruiting
Tor Vergata Hospital
Roma, 00133
About this study
Official title: Telehealth vs In-person Education for Enhancing Self-care of Ostomy Patients (SELF-STOMA): Study Design of a Non-inferiority, Randomized Controlled Trial
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.
Read the detailed description
After signing the informed consent form, patients with ostomy will be assigned to the intervention or active control group (1:1). The intervention group will receive a total of four remote educational sessions over 2 months. The control group will receive the standard care, consisting of in-person standard education.
- Conditions
- Ostomy
- Being tested
- Remote self-care education, In-person self-care education
- Keywords
- randomized controlled trial, ostomy, telehealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote self-care educationBehavioural
The intervention group will receive a total of four remote educational sessions over 2 months.
In-person self-care educationBehavioural
The active comparator group will receive a total of four in-person educational sessions over 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will receive a total of four remote educational sessions over 2 months. Receives: Behavioral: Remote self-care education |
| Control group | Active comparator | The control group will receive the standard care, consisting of in-person standard education. Receives: Behavioral: In-person self-care education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month after the last intervention
Secondary outcomes (9)
Self-care monitoring
Self-care monitoring will be measured with the Ostomy Self-care Index (OSCI). Scores range from 0 to 100, with higher scores indicating better self-care monitoring
Measured: 1 month after the last intervention
Self-care management
Self-care management will be measured with the Ostomy Self-care Index (OSCI). Scores range from 0 to 100, with higher scores indicating better self-care management
Measured: 1 month after the last intervention
Self-care self-efficacy
Self-care self-efficacy will be measured with the Ostomy Self-care Index (OSCI). Scores range from 0 to 100, with higher scores indicating better self-care self-efficacy
Measured: 1 month after the last intervention
Stoma-specific quality of life
Stoma-specific quality of life will be measured with the Stoma Specific Quality of Life Index- Scores on this scale range from 20 to 80, with higher scores meaning higher quality of life
Measured: 1 month after the last intervention
Depression
Depression will be measured with the Patient Health Questionnaire 9 (PHQ-9). Scores on this scale range from 0 to 27, with higher scores indicating higher depression
Measured: 1 month after the last intervention
Adjustment to the stoma
Adjustment to the stoma will be measured with the Stoma Adjustment Inventory-23. scores on this scale range from 0 to 92, with higher scores meaning better adjustment
Measured: 1 month after the last intervention
Stomal and peristomal complications rates
Stomal and peristomal complications rates will be collected with a questionnaire developed by the research team.
Measured: 1 month after the last intervention
Health care service utilization
Health care service utilization will be collected with a questionnaire developed by the research team.
Measured: 1 month after the last intervention
Mobility (distance in km from the patient house to the hospital and vice versa, means of transportation used, and presence of a companion)
Mobility will be collected with a questionnaire developed by the research team.
Measured: 1 month after the last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start14 Jun 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OstomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ercole Vellone, University of Rome Tor Vergata
- Investigators
- Ercole Vellone, Professor, Principal investigator, Department of Biomedicine and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796544
- Sponsor's protocol ID
- N.119.22
- Acronym
- SELF-STOMA
- Status last verified
- Sep 2023
- First submitted
- 3 Mar 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 227394262. 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.
PubMed 38924038
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth vs In-person Education for Enhancing Self-care of Ostomy Patients (SELF-STOMA): Study Design of a Non-inferiority, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05796544
- Acronym / sponsor ID
- SELF-STOMA / N.119.22
- Conditions
- Ostomy
- Keywords
- randomized controlled trial, ostomy, telehealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After signing the informed consent form, patients with ostomy will be assigned to the intervention or active control group (1:1). The intervention group will receive a total of four remote educational sessions over 2 months. The control group will receive the standard care, consisting of in-person standard education.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Remote self-care educationThe intervention group will receive a total of four remote educational sessions over 2 months. |
| Control group | Active comparator | Behavioral: In-person self-care educationThe control group will receive the standard care, consisting of in-person standard education. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote self-care educationThe intervention group will receive a total of four remote educational sessions over 2 months. | Behavioural | Intervention Group |
| In-person self-care educationThe active comparator group will receive a total of four in-person educational sessions over 2 months. | Behavioural | Control group |
Primary outcome
Self-care maintenance
Time frame: 1 month after the last intervention
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
9 secondary outcomes
Self-care monitoring
Time frame: 1 month after the last intervention
Self-care management
Time frame: 1 month after the last intervention
Self-care self-efficacy
Time frame: 1 month after the last intervention
Stoma-specific quality of life
Time frame: 1 month after the last intervention
Depression
Time frame: 1 month after the last intervention
Adjustment to the stoma
Time frame: 1 month after the last intervention
Stomal and peristomal complications rates
Time frame: 1 month after the last intervention
Health care service utilization
Time frame: 1 month after the last intervention
Mobility (distance in km from the patient house to the hospital and vice versa, means of transportation used, and presence of a companion)
Time frame: 1 month after the last intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Background: PubMed 22739426Riegel 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.
- Background2. 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.
- BackgroundCosta, 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
- Derived from this study: PubMed 38924038Iovino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ercole Vellone, Professor principal investigator
Department of Biomedicine and Prevention
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote self-care education and In-person self-care education in people with Ostomy, run by University of Rome Tor Vergata at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ercole Vellone, Professor (+390672596871, ercole.vellone@uniroma2.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-care maintenance (time frame: 1 month after the last intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05796544, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.