NCT05752253

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

February 26, 2023

Last Update Submit

February 28, 2023

Conditions

Hereditary Hemorrhagic Telangiectasia

Outcome Measures

Primary Outcomes (3)

  • Hospital Anxiety and Depression Scale (HADS)

    Administration of psychometric scales

    12 months

  • Connor-Davidson Resilience Scale (CD-RISC)

    Administration of psychometric scales

    12 months

  • Pittsburgh Sleep Quality Index (PSQI);

    Administration of psychometric scales

    12 months

Secondary Outcomes (1)

  • Impact of counseling on clients affected by rare diseases

    12 months

Study Arms (1)

Patients with Hereditary Hemorragic Teleangectasia

OTHER

Patients with Hereditary Hemorragic Teleangectasia

Other: Counseling

Interventions

CounselingOTHER

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.

Patients with Hereditary Hemorragic Teleangectasia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic

Interventions

Counseling

Condition Hierarchy (Ancestors)

Hemostatic DisordersVascular DiseasesCardiovascular DiseasesTelangiectasisHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 26, 2023

First Posted

March 2, 2023

Study Start

May 5, 2020

Primary Completion

February 2, 2022

Study Completion

May 30, 2022

Last Updated

March 2, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)