Multiple OsteochondromaRELOADNCT04844697
Resilience and Coping in a Rare Skeletal Disease Population to Face Coronavirus (COVID-19) Outbreak Distress: a Longitudinal Study
An observational study of Multiple Osteochondroma and Osteogenesis Imperfecta, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 24 years
- Conditions the study is for
- Multiple Osteochondroma, Osteogenesis Imperfecta, Ollier Disease
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 12 May 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- Subject doesn't match the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Resilience and Coping Strategies of Young Population in Response to Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Outbreak: a Longitudinal Study in a Cohort of Patients Affected by Rare Skeletal Disorders.
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.
Read the detailed description
March 11th, 2020, the World Health Organization (WHO) declared the SARS-CoV-2 pandemic accordingly with the spread and size of the infection.
The restrictions implemented by the governments have substantially changed people's lifestyles, facilitating the emergence of emotions such as fear, anxiety, and a sense of loneliness.
The age groups most involved by these burdens have been childhood, adolescence, and young adults. These groups have experienced dramatic changes in their daily life in order the relational, educational, and social networks. Nonetheless, these links outline the ideal environment for the development of resilience and the promotion of coping strategies to face traumatic events.
These lifestyle challenges and their consequences are even more evident in the context of the rare diseases since the outbreak containment measures have emphasized the troubles with which people affected by these conditions are daily forced to confront, in terms of access to care and treatments, resulting in increased stress and anxiety.
The current phase represents a sensitive step for the resumption of the activities in charge of the health and social service aimed at the citizens and especially to people with special needs, such as people suffering from rare diseases.
The pandemic experience has promoted new forms of meeting and contact between individuals using web-based platforms, playing a fundamental role in preserving the community and "sociality" dimensions.
In this scenario, the rare diseases could be an attractive model since the pandemic impinges over their bio-psycho-social characteristics at different levels. Resilience and coping strategies adopted by rare diseases patients could configure as an exemplum to face the psychological distress resulting from anti-pandemic measures, suggesting new approaches of taking charge by health service.
This study 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.
- Keywords
- COVID-19, Psychological Distress, e-Health, Children, Adolescents, Young Adults, Coping Strategies, Rare Diseases, Focus group
- Medical subject headings
- Exostoses, Multiple Hereditary, Osteogenesis Imperfecta, Enchondromatosis, COVID-19, Rare Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Change from baseline at 6 month
Secondary outcomes (9)
Anxiety
Hospital Anxiety and Depression Scale (HADS); 14 items: 7 items relate to anxiety and 7 relate to depression; a 4-point (0-3) Likert-scale; Cutoffs for both HADS-anxiety and HADS-depression as >= 8, and for HADS-total >= 15
Measured: Evaluation at baseline of the study
Anxiety
Hospital Anxiety and Depression Scale (HADS); 14 items: 7 items relate to anxiety and 7 relate to depression; a 4-point (0-3) Likert-scale; Cutoffs for both HADS-anxiety and HADS-depression as >= 8, and for HADS-total >= 15
Measured: Change from baseline at 3 month
Anxiety
Hospital Anxiety and Depression Scale (HADS); 14 items: 7 items relate to anxiety and 7 relate to depression; a 4-point (0-3) Likert-scale; Cutoffs for both HADS-anxiety and HADS-depression as >= 8, and for HADS-total >= 15
Measured: Change from baseline at 6 month
Depression
Hospital Anxiety and Depression Scale (HADS); 14 items: 7 items relate to anxiety and 7 relate to depression; a 4-point (0-3) Likert-scale; Cutoffs for both HADS-anxiety and HADS-depression as >= 8, and for HADS-total >= 15
Measured: Evaluation at baseline of the study
Depression
Hospital Anxiety and Depression Scale (HADS); 14 items: 7 items relate to anxiety and 7 relate to depression; a 4-point (0-3) Likert-scale; Cutoffs for both HADS-anxiety and HADS-depression as >= 8, and for HADS-total >= 15
Measured: Change from baseline at 3 month
Depression
Hospital Anxiety and Depression Scale (HADS); 14 items: 7 items relate to anxiety and 7 relate to depression; a 4-point (0-3) Likert-scale; Cutoffs for both HADS-anxiety and HADS-depression as >= 8, and for HADS-total >= 15
Measured: Change from baseline at 6 month
Loneliness
UCLA Loneliness Scale (Version 3); 20-item scale; 4-point rating scale (1=Never; 2=Rarely; 3=Sometimes; and 4=Often); score ranging from 20 to 80.
Measured: Evaluation at baseline of the study
Loneliness
UCLA Loneliness Scale (Version 3); UCLA Loneliness Scale (Version 3); 20-item scale; 4-point rating scale (1=Never; 2=Rarely; 3=Sometimes; and 4=Often); score ranging from 20 to 80.
Measured: Change from baseline at 3 month
Loneliness
UCLA Loneliness Scale (Version 3); UCLA Loneliness Scale (Version 3); 20-item scale; 4-point rating scale (1=Never; 2=Rarely; 3=Sometimes; and 4=Often); score ranging from 20 to 80.
Measured: Change from baseline at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start12 May 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple OsteochondromaStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Sangiorgi, Istituto Ortopedico Rizzoli
- Investigators
- Luca Sangiorgi, MD, Phd, Principal investigator, IRCCS Istituto ORtopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844697
- Sponsor's protocol ID
- 150/2021/Oss/IOR
- Acronym
- RELOAD
- Status last verified
- Feb 2023
- First submitted
- 12 Apr 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Resilience and Coping Strategies of Young Population in Response to Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Outbreak: a Longitudinal Study in a Cohort of Patients Affected by Rare Skeletal Disorders.
- ClinicalTrials.gov ID
- NCT04844697
- Acronym / sponsor ID
- RELOAD / 150/2021/Oss/IOR
- Keywords
- COVID-19, Psychological Distress, e-Health, Children, Adolescents, Young Adults, Coping Strategies, Rare Diseases, Focus group
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
March 11th, 2020, the World Health Organization (WHO) declared the SARS-CoV-2 pandemic accordingly with the spread and size of the infection.
The restrictions implemented by the governments have substantially changed people's lifestyles, facilitating the emergence of emotions such as fear, anxiety, and a sense of loneliness.
The age groups most involved by these burdens have been childhood, adolescence, and young adults. These groups have experienced dramatic changes in their daily life in order the relational, educational, and social networks. Nonetheless, these links outline the ideal environment for the development of resilience and the promotion of coping strategies to face traumatic events.
These lifestyle challenges and their consequences are even more evident in the context of the rare diseases since the outbreak containment measures have emphasized the troubles with which people affected by these conditions are daily forced to confront, in terms of access to care and treatments, resulting in increased stress and anxiety.
The current phase represents a sensitive step for the resumption of the activities in charge of the health and social service aimed at the citizens and especially to people with special needs, such as people suffering from rare diseases.
The pandemic experience has promoted new forms of meeting and contact between individuals using web-based platforms, playing a fundamental role in preserving the community and "sociality" dimensions.
In this scenario, the rare diseases could be an attractive model since the pandemic impinges over their bio-psycho-social characteristics at different levels. Resilience and coping strategies adopted by rare diseases patients could configure as an exemplum to face the psychological distress resulting from anti-pandemic measures, suggesting new approaches of taking charge by health service.
This study 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Subject doesn't match the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resilience
Time frame: Evaluation at baseline of the study
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
Resilience
Time frame: Change from baseline at 3 month
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
Resilience
Time frame: Change from baseline at 6 month
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
9 secondary outcomes
Anxiety
Time frame: Evaluation at baseline of the study
Anxiety
Time frame: Change from baseline at 3 month
Anxiety
Time frame: Change from baseline at 6 month
Depression
Time frame: Evaluation at baseline of the study
Depression
Time frame: Change from baseline at 3 month
Depression
Time frame: Change from baseline at 6 month
Loneliness
Time frame: Evaluation at baseline of the study
Loneliness
Time frame: Change from baseline at 3 month
Loneliness
Time frame: Change from baseline at 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Multiple Osteochondroma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Sangiorgi, MD, Phd principal investigator
IRCCS Istituto ORtopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Osteochondroma and Osteogenesis Imperfecta, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience (time frame: Evaluation at baseline of the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.