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 | Recruiting

• 1 other identifier: AMH
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hereditary Transthyretin Amyloidosis

Outcome Measures

Primary Outcomes (2)

• The feasibility of a psychological support program

  measured by calculating the percentage of interviews in which the patient participates, at least 80%.

  12 months

• Acceptance of a psychological support program

  Acceptability will be assessed based on how many T0 patients accept psychological support

  12 months

Study Arms (1)

Patient with Hereditary Transthyretin Amyloidosis

OTHER

Patient with Hereditary Transthyretin Amyloidosis

Other: Psychological Support

Interventions

Psychological Support OTHER

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

Patient with Hereditary Transthyretin Amyloidosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

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

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Amyloidosis, Hereditary, Transthyretin-Related

Central Study Contacts

Laura Obici, MD

CONTACT

+390382502983; l.obici@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: May 24, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

IT (1)