Tele-consultation to improve colonoscopy quality and reduce anxiety
Evaluation of the Effectiveness of Nurse Tele-consultation on the Quality of Elective Colonoscopy, Procedure-related Anxiety, and Financial Toxicity
This study tests if a tele-consultation with nurses can help people getting a colonoscopy feel less anxious and better prepared for the procedure compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 534 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | National Cancer Institute, Naples Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT06887244 on ClinicalTrials.gov |
What this trial studies
This multicenter, non-pharmacological study evaluates the effectiveness of a tele-consultation procedure conducted by nursing staff for patients undergoing elective colonoscopy. The study aims to enhance patient adherence to bowel preparation methods, reduce procedure-related anxiety, and assess financial toxicity associated with the procedure. Participants are randomly assigned to receive either the tele-consultation or standard care, with outcomes measured in terms of exam quality and patient satisfaction. The study is designed to provide insights into the practical application of telehealth in gastroenterology.
Who should consider this trial
Good fit: Ideal candidates include adults eligible for outpatient pancolonoscopy for diagnostic, screening, or follow-up purposes.
Not a fit: Patients under 18 or over 80 years of age, those with cognitive impairments, or those with contraindications to bowel preparation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved patient experiences and outcomes during elective colonoscopy procedures.
How similar studies have performed: Other studies have shown promising results with telehealth interventions in various medical fields, suggesting potential success for this approach in gastroenterology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects eligible for outpatient pancolonoscopy: * for diagnostic purposes; * for screening purposes; * for post-polypectomy follow-up; * of both genders; * of all ethnicities; Exclusion Criteria: * Patients under 18 years of age or over 80 years of age; * Patients on waiting lists with SHORT priority: the procedure to be provided within a short time (no more than 10 days); * Patients included in GOM pathways who undergo colonoscopy within 10 days; * Pregnancy; * Presence of known contraindications to bowel preparation; * Presence of known contraindications to performing pancolonoscopy; * Patients who have undergone colonic resection and/or have a colostomy/ileostomy; * Patients with cognitive impairments; * Patients declared legally incompetent or unable to understand and make decisions; * Patients unable to provide informed consent.
Where this trial is running
Naples
- S.S.D. Garoenterologia ed Endoscopia Digestiva — Naples, Italy (Recruiting)
Study contacts
- Principal investigator: Francesco De Falco, Nursing degree — National Cancer Institute, IRCCS Fondazione G. Pascale
- Study coordinator: Francesco De Falco, Nursing degree
- Email: endoscopia@istitutotumori.na.it
- Phone: 0811770813
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.