Clinical trial NCT04844697: Resilience and Coping in a Rare Skeletal Disease Population to Face Coronavirus (COVID-19) Outbreak Distress: a Longitudinal 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Osteochondroma
Osteogenesis Imperfecta
Ollier Disease
Maffucci Syndrome
Keywords: COVID-19
Psychological Distress
e-Health
Children, Adolescents, Young Adults
Coping Strategies
Rare Diseases
Focus group
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Subject doesn't match the inclusion criteria

Primary outcomes:
measure: Resilience
timeFrame: Evaluation at baseline of the study
measure: Resilience
timeFrame: Change from baseline at 3 month
measure: Resilience
timeFrame: Change from baseline at 6 month
Secondary outcomes:
measure: Anxiety
timeFrame: Evaluation at baseline of the study
measure: Anxiety
timeFrame: Change from baseline at 3 month
measure: Anxiety
timeFrame: Change from baseline at 6 month
measure: Depression
timeFrame: Evaluation at baseline of the study
measure: Depression
timeFrame: Change from baseline at 3 month
measure: Depression
timeFrame: Change from baseline at 6 month
measure: Loneliness
timeFrame: Evaluation at baseline of the study
measure: Loneliness
timeFrame: Change from baseline at 3 month
measure: Loneliness
timeFrame: Change from baseline at 6 month
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
affiliation: IRCCS Istituto ORtopedico Rizzoli
name: Luca Sangiorgi, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: