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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-24

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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The overall objective of the study is to evaluate the feasibility, acceptance and preliminary efficacy data of a structured psychological support program for patients, caregivers and presymptomatic carriers in hereditary transthyretin amyloidosis (ATTRv) with cardiomyopathy.

The primary objective is to evaluate the feasibility of a psychological support program for patients, caregivers and presymptomatic carriers.

The co-primary objective is to evaluate the acceptance by patients of the proposed psychological support program.Key secondary objective: Evaluate the effects of the psychological support program on the levels of anxiety and depression in patients and presymptomatic carriers of ATTRv during the psychological support pathway (at 6 months) and at the end (at 12 months);

Conditions

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Hereditary Transthyretin Amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patient with Hereditary Transthyretin Amyloidosis

Group Type OTHER

Psychological Support

Intervention Type OTHER

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

Interventions

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Psychological Support

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No