Psychological support program for patients with hereditary transthyretin amyloidosis
A Single-arm Interventional Pilot Study to Investigate the Feasibility and Acceptance of a Structured Psychological Support Program for Patients, Caregivers, and Presymptomatic Carriers in Hereditary Transthyretin Amyloidosis With Cardiomyopathy
NA · Fondazione IRCCS Policlinico San Matteo di Pavia · NCT06907186
This study is testing a new psychological support program for patients and their families dealing with hereditary transthyretin amyloidosis to see if it helps reduce feelings of anxiety and depression over a year.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia (other) |
| Locations | 1 site (Pavia) |
| Trial ID | NCT06907186 on ClinicalTrials.gov |
What this trial studies
This study evaluates a structured psychological support program aimed at patients, caregivers, and presymptomatic carriers of hereditary transthyretin amyloidosis (ATTRv) with cardiomyopathy. The primary focus is to assess the feasibility and acceptance of this program, while also measuring its impact on anxiety and depression levels over a 12-month period. Participants will receive psychological support tailored to address the emotional and psychosocial challenges associated with this progressive disease. The study is conducted at the Amyloidosis Center of the Fondazione IRCCS Policlinico San Matteo in Pavia.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are patients, presymptomatic carriers, or caregivers involved with the Amyloidosis Center in Pavia.
Not a fit: Patients diagnosed with other types of amyloidosis will not benefit from this specific psychological support program.
Why it matters
Potential benefit: If successful, this program could significantly improve the mental well-being and quality of life for patients and their families affected by hereditary transthyretin amyloidosis.
How similar studies have performed: While specific studies on psychological support for ATTRv patients are limited, similar approaches in other chronic conditions have shown positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Minimum age of 18 years; * Fluent in Italian; * Patient, presymptomatic carrier or ATTRv caregiver, in charge of UOC General Medicine 2 - Amyloidosis Center of the Fondazione IRCCS Policlinico San Matteo in Pavia; * Signing of the specific Informed Consent Exclusion Criteria: * Subjects who, although belonging to UOC General Medicine 2 - Amyloidosis Center of the Fondazione IRCCS Policlinico San Matteo in Pavia - present a diagnosis of another type of amyloidosis.
Where this trial is running
Pavia
- Fondazione IRCCS Policlinico San Matteo, Medicina Generale 2 - Centro Amiloidosi Sistemiche e Malattie ad Alta Complessità — Pavia, Italy (RECRUITING)
Study contacts
- Study coordinator: Laura Obici, MD
- Email: l.obici@smatteo.pv.it
- Phone: +390382502983
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.
Conditions: Hereditary Transthyretin Amyloidosis