Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Completed
• CT.gov ID: NCT05752253
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Actual Duration (Months): 24.8
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hereditary Hemorrhagic Telangiectasia	Other: Counseling	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.
• Actual Study Start Date: May 5, 2020
• Actual Primary Completion Date: Feb 2, 2022
• Actual Study Completion Date: May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients with Hereditary Hemorragic Teleangectasia Patients with Hereditary Hemorragic Teleangectasia	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.

Outcome Measures

Primary Outcome Measures

1. Hospital Anxiety and Depression Scale (HADS) [12 months]

   Administration of psychometric scales

2. Connor-Davidson Resilience Scale (CD-RISC) [12 months]

   Administration of psychometric scales

3. Pittsburgh Sleep Quality Index (PSQI); [12 months]

   Administration of psychometric scales

Secondary Outcome Measures

1. Impact of counseling on clients affected by rare diseases [12 months]

   Administration of psychometric scales

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Gemelli IRCCS	Rome		Italy	00168

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mazza Marianna, Medical Doctor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05752253
• Other Study ID Numbers: 3136
• First Posted: Mar 2, 2023
• Last Update Posted: Mar 2, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Telangiectasis; Telangiectasia, Hereditary Hemorrhagic

Study Results

No Results Posted as of Mar 2, 2023