Qualitative Study Patient & Physician Experiences Botox COVID-19

NCT05435404 | Completed

• 1 other identifier: EastKHT
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

During the COVID-19 pandemic and subsequent series of Lockdowns, clinic out-patient spasticity services were replaced with video based tele-consultation appointments, in order to reduce the potential risk of virus transmission between patients and clinicians in either direction. This meant that for an extensive period of time, this treatment could not be offered, and like many other specialist services, this resulted in a backlog of case referrals and an extensive clinic waiting list, where patient appointments and referrals were delayed by the pandemic. There have been discussions in many professional network forums that have suggested that the necessary changes to appointments during the pandemic may have contributed to a build-up of pain and disability for patients who were unable to access spasticity management treatment when they needed it. This research aims to gain insight and understanding of the individual experiences and perceptions of patients, carers and a physician who have been involved in spasticity treatment out-patient service clinics during and post COVID 19 pandemic. To do this, a qualitative research approach has been adopted and a group of 10 potential participants along with one consultant physician will be invited to participate in the study. Participants will be provided with information on the research (Participant Information Sheet) and asked to provide written informed consent (Consent Form) in order to take part. After providing consent, the participant will be interviewed via telephone. Data will be analysed using a thematic approach by the research team to identify the challenges, opportunities and barriers that may have been encountered during the pandemic and post pandemic period. All participants will be provided with a debrief document.

Conditions

Chronic Brain Injury; Cerebral Stroke; MS (Multiple Sclerosis)

Keywords

spasticity; botulinum toxin; qualitative research; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Interview with participant

  Telephone interview between member of research team and participant

  1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with a diagnosis of severe muscle spasticity related to a neurological condition, who require treatment with Botulinum Toxin injection by a Consultant Physician and who are usually seen in Out-patient clinics in East Kent.

You may qualify if:

• Adults aged 18 and over with a diagnosis of severe spasticity, who are recommended to have Botulinum Toxin injection treatment in East Kent Hospital University NHS Foundation Trust (EKHUFT) Out-patient clinics.

You may not qualify if:

• Adults aged 18 and over who do not have a diagnosis of severe muscle spasticity that requires treatment with Botulinum Toxin injection.
• Adults unable to provide informed consent

Sponsors & Collaborators

• East Kent Hospitals University NHS Foundation Trust: lead

Study Sites (1)

East Kent Hospitals University NHS Trust

Canterbury, Kent, CT1 3NG, United Kingdom

Location

MeSH Terms

Conditions

Brain Injury, Chronic; Stroke; Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mohamed Dr Sakel, MBBS

  East Kent Hospitals University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: June 28, 2022
• Study Start: October 8, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)