Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.

Hereditary Hemorrhagic Telangiectasia Clinical Trial

Official title:

Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05752253
• Other study ID #: 3136
• Status: Completed
• Phase: N/A
• Start date: May 5, 2020
• Est. completion date: May 30, 2022

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 30, 2022
• Est. primary completion date: February 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hereditary Hemorrhagic Telangiectasia
• Telangiectasia, Hereditary Hemorrhagic
• Telangiectasis

Intervention

Other:
• Counseling
Counseling is a process which, through positive orientation and the enhancement of personal resources, is aimed at promoting the improvement of the quality of life in the other.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression Scale (HADS)	Administration of psychometric scales	12 months
Primary	Connor-Davidson Resilience Scale (CD-RISC)	Administration of psychometric scales	12 months
Primary	Pittsburgh Sleep Quality Index (PSQI);	Administration of psychometric scales	12 months
Secondary	Impact of counseling on clients affected by rare diseases	Administration of psychometric scales	12 months