Perceptions of the Clinical and Psychosocial Impact of Covid-19 in Patients With Neuromuscular and Neurological Disorders (CLASSIC)

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.

Study Overview

• Status: Recruiting
• Conditions: Neuromuscular Diseases; Neurological Diseases or Conditions
• Intervention / Treatment: Other: Semi-structured telephone questionnaire

• Study Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

• Study Contact: Name: Lydia Spurr, MBBS; Phone Number: 0207 352 8121; Email: l.spurr@rbht.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6HP
    • Recruiting
    • Royal Brompton Hospital
    • Contact: Lydia A Spurr, MBBS BMedSci; Phone Number: 0207 352 8121; Email: l.spurr@rbht.nhs.uk
    • Principal Investigator: Anita K Simonds, MD MBBS
    • Sub-Investigator: Martin R Cowie, MD MSc
    • Sub-Investigator: Mary Morrell, PhD
    • Sub-Investigator: Kinesh Patel, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Unwilling for telephone questionnaire to be audio-recorded

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patients with neuromuscular or neurological disorders; Telephone questionnaires administered directly to patients over 16 years of age with neuromuscular or neurological disorders	Other: Semi-structured telephone questionnaire; 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	Other: Semi-structured telephone questionnaire; Semi-structured telephone questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 months
Qualitative evaluation of the social environment of patients with NMDs	Qualitative analysis describing the social environment of patients with NMDs	4 months
Qualitative evaluation of the social activities of patients with NMDs	Qualitative analysis describing the social activities of patients with NMDs	4 months
Qualitative evaluation of the professional activities of patients with NMDs	Qualitative analysis describing the professional activities of patients with NMDs	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	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	4 months

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Investigators: Principal Investigator: Anita Simonds, MBBS, Royal Brompton & Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: 286495

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No