RecruitingNot ApplicableNCT06907186

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

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


Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Enrollment

150 participants

Start Date

May 24, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria1

  • 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.

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Interventions

OTHERPsychological Support

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


Locations(1)

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

Pavia, Italy

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NCT06907186


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