NCT04844697

Brief Summary

In the COVID-19 outbreak context, people living with rare diseases have been highly troubled with anxiety, loneliness, and depression. The project evaluates resilience and coping strategies to address pandemic impact by discussion in a dedicated focus group using a web-based platform. The goal is to improve, in a sustainable manner, the coping skills and psychological well-being of children, adolescents, and young adults affected by rare skeletal diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

May 12, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

April 12, 2021

Last Update Submit

February 28, 2023

Conditions

Multiple OsteochondromaOsteogenesis ImperfectaOllier DiseaseMaffucci Syndrome

Keywords

COVID-19Psychological Distresse-HealthChildren, Adolescents, Young AdultsCoping StrategiesRare DiseasesFocus group

Outcome Measures

Primary Outcomes (3)

  • Resilience

    Ego-Resiliency Scale (ER89); 14 items; 4-point Likert scale (1=does not apply at all; 2=applies slightly, if at all; 3=applies somewhat; and 4=applies very strong); Score Resiliency Trait: 47-56 Very High, 35-46 High, 23-34 Undetermined, 11-22 Low, 0-10 Very Low

    Evaluation at baseline of the study

  • Resilience

    Ego-Resiliency Scale (ER89); 14 items; 4-point Likert scale (1=does not apply at all; 2=applies slightly, if at all; 3=applies somewhat; and 4=applies very strong); Score Resiliency Trait: 47-56 Very High, 35-46 High, 23-34 Undetermined, 11-22 Low, 0-10 Very Low

    Change from baseline at 3 month

  • Resilience

    Ego-Resiliency Scale (ER89); 14 items; 4-point Likert scale (1=does not apply at all; 2=applies slightly, if at all; 3=applies somewhat; and 4=applies very strong); Score Resiliency Trait: 47-56 Very High, 35-46 High, 23-34 Undetermined, 11-22 Low, 0-10 Very Low

    Change from baseline at 6 month

Secondary Outcomes (9)

  • Anxiety

    Evaluation at baseline of the study

  • Anxiety

    Change from baseline at 3 month

  • Anxiety

    Change from baseline at 6 month

  • Depression

    Evaluation at baseline of the study

  • Depression

    Change from baseline at 3 month

  • +4 more secondary outcomes

Eligibility Criteria

Age8 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patient screening and enrollment will be carried out through: * Rare Skeletal Disorders out-patient visit * Rare Skeletal Disorders in-patient visit * National Patients Organizations

You may qualify if:

  • Clinical and/or molecular diagnosis of Multiple osteochondromas; Clinical and/or molecular diagnosis of Ollier disease/Maffucci syndrome; Clinical and/or molecular diagnosis of Osteogenesis imperfecta; Consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40139, Italy

Location

MeSH Terms

Conditions

Exostoses, Multiple HereditaryOsteogenesis ImperfectaEnchondromatosisCOVID-19Rare Diseases

Condition Hierarchy (Ancestors)

OsteochondromatosisOsteochondromaNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplastic Syndromes, HereditaryOsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesExostosesHyperostosisGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Luca Sangiorgi, MD, Phd

    IRCCS Istituto ORtopedico Rizzoli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Rare Skeletal Disorders Department

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 14, 2021

Study Start

May 12, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)