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Clinical Trials in Italy / NCT06907186
Recruiting Not applicable

An 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

NCT06907186 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Phase
Not applicable
Started
2024-05-24
Last updated
2025-04-06

Condition(s) studied

Hereditary Transthyretin Amyloidosis

Investigational drug(s) / intervention(s)

Psychological Support

Psychological Support: Carrying out a systematic and organized path of psychological support interviews on a monthly basis in person or remotely.

Study summary

Hereditary transthyretin amyloidosis (ATTRv) is a genetic, progressive and disabling disease that affects multiple organs and severely compromises the quality of life of patients and their families. A holistic approach is essential, which, in addition to early diagnosis and clinical management, includes psychological support to address the emotional and psychosocial impact of the disease. Although specific interventions for mental well-being are recommended, studies evaluating support tools for patients with ATTRv cardiomyopathy and their caregivers are lacking.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The feasibility of a psychological support program — 12 months
    measured by calculating the percentage of interviews in which the patient participates, at least 80%.
  • Acceptance of a psychological support program — 12 months
    Acceptability will be assessed based on how many T0 patients accept psychological support

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Policlinico San Matteo, Medicina Generale 2 - Centro Amiloidosi Sistemiche e Malattie ad Alta Complessità Pavia Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06907186 on ClinicalTrials.gov ↗ ← All trials in Italy