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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.
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);
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with Hereditary Transthyretin Amyloidosis | Other | Patient with Hereditary Transthyretin Amyloidosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychological Support | Other | Carrying out a systematic and organized path of psychological support interviews on a monthly basis in person or remotely. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Obici, MD | Contact | +390382502983 | l.obici@smatteo.pv.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo, Medicina Generale 2 - Centro Amiloidosi Sistemiche e Malattie ad Alta Complessità | Recruiting | Pavia | 27100 | Italy |
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| ID | Term |
|---|---|
| C567782 | Amyloidosis, Hereditary, Transthyretin-Related |
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