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Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.

Primary Purpose

Hereditary Hemorrhagic Telangiectasia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Counseling
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hereditary Hemorrhagic Telangiectasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fondazione Policlinico Gemelli IRCCS

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with Hereditary Hemorragic Teleangectasia

Arm Description

Patients with Hereditary Hemorragic Teleangectasia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Impact of counseling on clients affected by rare diseases
Administration of psychometric scales

Full Information

First Posted
February 26, 2023
Last Updated
February 28, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05752253
Brief Title
Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.
Official Title
Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 5, 2020 (Actual)
Primary Completion Date
February 2, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Hemorrhagic Telangiectasia

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with Hereditary Hemorragic Teleangectasia
Arm Type
Other
Arm Description
Patients with Hereditary Hemorragic Teleangectasia
Intervention Type
Other
Intervention Name(s)
Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Administration of psychometric scales
Time Frame
12 months
Title
Connor-Davidson Resilience Scale (CD-RISC)
Description
Administration of psychometric scales
Time Frame
12 months
Title
Pittsburgh Sleep Quality Index (PSQI);
Description
Administration of psychometric scales
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Impact of counseling on clients affected by rare diseases
Description
Administration of psychometric scales
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fondazione Policlinico Gemelli IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.

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