Counseling Intervention in Hereditary Hemorrhagic Telangi... | NCT05752253

Studies
Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.

NCT05752253

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Completed

Last Update Posted

Mar 2, 2023Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Hereditary Hemorrhagic Telangiectasia

Interventions

Counseling

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 5, 2020Actual

Primary Completion Date

Feb 2, 2022Actual

Completion Date

May 30, 2022Actual

First Submitted Date

Feb 26, 2023

First Submission Date that Met QC Criteria

Feb 28, 2023

First Posted Date

Mar 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2023

Last Update Posted Date

Mar 2, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mazza Marianna, Medical Doctor, Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Hereditary Hemorragic Teleangectasia	Other	Patients with Hereditary Hemorragic Teleangectasia	Other: Counseling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Counseling	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Impact of counseling on clients affected by rare diseases	Administration of psychometric scales	12 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Gemelli IRCCS		Rome		00168	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013683	Telangiectasia, Hereditary Hemorrhagic

Ancestor Terms

ID	Term
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D013684	Telangiectasis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003376	Counseling

Ancestor Terms

ID	Term
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities
D003153	Community Health Services
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided