Neuromuscular DiseasesCLASSICNCT04581577
Perceptions of the Clinical and Psychosocial Impact of Covid-19 in Patients With NMD
An observational study of Neuromuscular Diseases and Neurological Diseases or Conditions, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study aims to evaluate perceived clinical and psychosocial experiences of patients and their families during the Covid-19 pandemic. it is important to understand the implications of the pandemic for this population, particularly given its likely protracted course, and resultant limitations to daily activities and… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Diseases, Neurological Diseases or Conditions
- What is being tested?
- Semi-structured telephone questionnaire
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Sep 2020to 31 Dec 2020
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with a diagnosis of a neuromuscular and/or neurological disorder including Duchenne muscular dystrophy, spinal muscular atrophy, congenital muscular dystrophies, and other neuromuscular and neurological disorders
Who may be able to join
- Adult group
- Patient over 16 years of age with a confirmed diagnosis of neuromuscular and/or neurological disorder
- Able and willing to provide informed consent
- Paediatric group
- Parent of a patient under 16 years of age with a confirmed diagnosis of neuromuscular and/or neurological disorder
- Able and willing to provide informed consent
Who cannot join
- Unwilling for telephone questionnaire to be audio-recorded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perceptions of the Clinical and Psychosocial Impact of Covid-19 in Patients With Neuromuscular and Neurological Disorders
This study aims to evaluate perceived clinical and psychosocial experiences of patients and their families during the Covid-19 pandemic. it is important to understand the implications of the pandemic for this population, particularly given its likely protracted course, and resultant limitations to daily activities and clinical care. This will help clinicians plan support and adaptations to the services they provide in the medium to long term.
Read the detailed description
As above
- Being tested
- Semi-structured telephone questionnaire
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured telephone questionnaireOther
Semi-structured telephone questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with neuromuscular or neurological disorders | Telephone questionnaires administered directly to patients over 16 years of age with neuromuscular or neurological disorders Receives: Other: Semi-structured telephone questionnaire | |
| Parents of paediatric patients with neuromuscular or neurological disorders | Telephone questionnaires administered to the parents of patients over 16 years of age with neuromuscular or neurological disorders Receives: Other: Semi-structured telephone questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative evaluation of the perceived clinical and psychosocial impact of the Covid-19 pandemic in patients with neuromuscular and neurological disorders
Evaluation of semi-structured questionnaires using thematic analysis
Measured: 4 months
Secondary outcomes (6)
Quantification of the proportion of patients with NMD who have had suspected or confirmed Covid-19 infection during the pandemic
Quantitative analysis of the proportion of questionnaire respondents reporting confirmed or suspected Covid-19 infection
Measured: 4 months
Qualitative evaluation of the social environment of patients with NMDs
Qualitative analysis describing the social environment of patients with NMDs
Measured: 4 months
Qualitative evaluation of the social activities of patients with NMDs
Qualitative analysis describing the social activities of patients with NMDs
Measured: 4 months
Qualitative evaluation of the professional activities of patients with NMDs
Qualitative analysis describing the professional activities of patients with NMDs
Measured: 4 months
Qualitative evaluation of the impact of the Covid-19 pandemic on families of patients with neuromuscular and neurological disorders
Evaluation of semi-structured questionnaires using thematic analysis
Measured: 4 months
Qualitative evaluation of concerns regarding medical care from the perspective of patients with NMDs and their families during the Covid-19 pandemic
Evaluation of semi-structured questionnaires using thematic analysis
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start11 Sep 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita Simonds, MBBS, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581577
- Sponsor's protocol ID
- 286495
- Acronym
- CLASSIC
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2020
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spurr L, Tan HL, Wakeman R, Chatwin M, Hughes Z, Simonds A. Psychosocial impact of the COVID-19 pandemic and shielding in adults and children with early-onset neuromuscular and neurological disorders and their families: a mixed-methods study. BMJ Open. 2022 Mar 30;12(3):e055430. doi: 10.1136/bmjopen-2021-055430.
PubMed 35354630
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptions of the Clinical and Psychosocial Impact of Covid-19 in Patients With Neuromuscular and Neurological Disorders
- ClinicalTrials.gov ID
- NCT04581577
- Acronym / sponsor ID
- CLASSIC / 286495
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Oct 2020 (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.
This study aims to evaluate perceived clinical and psychosocial experiences of patients and their families during the Covid-19 pandemic. it is important to understand the implications of the pandemic for this population, particularly given its likely protracted course, and resultant limitations to daily activities and clinical care. This will help clinicians plan support and adaptations to the services they provide in the medium to long term.
Detailed description
As above
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult patients with neuromuscular or neurological disorders | – | Other: Semi-structured telephone questionnaireTelephone questionnaires administered directly to patients over 16 years of age with neuromuscular or neurological disorders |
| Parents of paediatric patients with neuromuscular or neurological disorders | – | Other: Semi-structured telephone questionnaireTelephone questionnaires administered to the parents of patients over 16 years of age with neuromuscular or neurological disorders |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a diagnosis of a neuromuscular and/or neurological disorder including Duchenne muscular dystrophy, spinal muscular atrophy, congenital muscular dystrophies, and other neuromuscular and neurological disorders
Key inclusion criteria (6 listed)
- Adult group
- Patient over 16 years of age with a confirmed diagnosis of neuromuscular and/or neurological disorder
- Able and willing to provide informed consent
- Paediatric group
- Parent of a patient under 16 years of age with a confirmed diagnosis of neuromuscular and/or neurological disorder
Key exclusion criteria (1 listed)
- Unwilling for telephone questionnaire to be audio-recorded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured telephone questionnaireSemi-structured telephone questionnaire | Other | Adult patients with neuromuscular or neurological disorders, Parents of paediatric patients with neuromuscular or neurological disorders |
Primary outcome
Qualitative evaluation of the perceived clinical and psychosocial impact of the Covid-19 pandemic in patients with neuromuscular and neurological disorders
Time frame: 4 months
Evaluation of semi-structured questionnaires using thematic analysis
6 secondary outcomes
Quantification of the proportion of patients with NMD who have had suspected or confirmed Covid-19 infection during the pandemic
Time frame: 4 months
Qualitative evaluation of the social environment of patients with NMDs
Time frame: 4 months
Qualitative evaluation of the social activities of patients with NMDs
Time frame: 4 months
Qualitative evaluation of the professional activities of patients with NMDs
Time frame: 4 months
Qualitative evaluation of the impact of the Covid-19 pandemic on families of patients with neuromuscular and neurological disorders
Time frame: 4 months
Qualitative evaluation of concerns regarding medical care from the perspective of patients with NMDs and their families during the Covid-19 pandemic
Time frame: 4 months
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 16 Oct 2024.
- Results publication: PubMed 35354630Spurr L, Tan HL, Wakeman R, Chatwin M, Hughes Z, Simonds A. Psychosocial impact of the COVID-19 pandemic and shielding in adults and children with early-onset neuromuscular and neurological disorders and their families: a mixed-methods study. BMJ Open. 2022 Mar 30;12(3):e055430. doi: 10.1136/bmjopen-2021-055430.
- Individual participant dataSharing planned: No
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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.
Anita Simonds, MBBS principal investigator
Royal Brompton & Harefield NHS Foundation Trust
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 Neuromuscular Diseases and Neurological Diseases or Conditions, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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 6 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 16 Oct 2024. 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 United Kingdom. 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?
Qualitative evaluation of the perceived clinical and psychosocial impact of the Covid-19 pandemic in patients with neuromuscular and neurological disorders (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04581577, which also lists 1 linked publication.
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 16 Oct 2024.