Hereditary Transthyretin Amyloidosis
Conditions
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.
Detailed description
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);
Interventions
OTHERPsychological Support
Carrying out a systematic and organized path of psychological support interviews on a monthly basis in person or remotely.
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactLaura Obici, MD
Outcome results
None listed