Back to resultsCounseling 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
About this trial
This is an interventional screening trial for Hereditary Hemorrhagic Telangiectasia
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.
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
NCT ID
NCT05752253
First Posted
February 26, 2023
Last Updated
February 28, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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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