Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.

Not Applicable

Completed

• Conditions: Hereditary Hemorrhagic Telangiectasia
• Interventions: Other: Counseling

• Registration Number: NCT05752253
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

The goal of this interventional study is to determine the incidence of depression, anxiety, sleep disturbances and resilience in a sample of subjects affected by Hereditary Hemorrhagic Telangiectasia. The study is declined through the evaluation of some outcome parameters at the time of enrollment (T0), during the counseling intervention (T1 and T2) and at the end (T3) of the subjects who will have carried out an individual counseling intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-05
• Primary Completion: 2022-02-02
• Study Completion: 2022-05-30
• Status Verified: 2023-02
• Study First Submitted: 2023-02-26
• Study First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Study First Posted: 2023-03-02
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Recruited subjects have a diagnosis of Hereditary Hemorrhagic Telangiectasia and are 18 years of age or older.

Exclusion Criteria

Previous or current intellectual disability and a diagnosis of psychiatric disorders in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-5.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Hereditary Hemorragic Teleangectasia	Counseling	Patients with Hereditary Hemorragic Teleangectasia

Primary Outcome Measures

Name	Time	Method
Connor-Davidson Resilience Scale (CD-RISC)	12 months	Administration of psychometric scales
Hospital Anxiety and Depression Scale (HADS)	12 months	Administration of psychometric scales
Pittsburgh Sleep Quality Index (PSQI);	12 months	Administration of psychometric scales

Secondary Outcome Measures

Name	Time	Method
Impact of counseling on clients affected by rare diseases	12 months	Administration of psychometric scales

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli IRCCS; 🇮🇹 Rome, Italy