Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05435404 |
| Other study ID # |
EastKHT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 8, 2021 |
| Est. completion date |
April 30, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
East Kent Hospitals University NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
The idea for this study came out of a shared online discussion between healthcare
professionals, managers and the Principal Investigator during the last 18 months of the
COVID-19 Pandemic period.
Aims and Objectives:
1. To explore the different perceptions of risks associated with attending an Out-patient
appointment for BoNT injection treatment by patients, carers and medical doctors, who
routinely use BoNT for spasticity management.
2. To identify potential barriers, which may be physical and/or psychological which
influence choice and decision making by patients and doctors
3. To gain insight and understanding of potential perceived harms versus benefits regarding
treatment decision making process from different perspectives (patients and doctors)
4. To gain insight and understanding of how attitudes and behaviours may have changed now
because of COVID-19
5. To invite consideration of how identified barriers might potentially be overcome.
6. To invite ideas and perspectives on whether the development of a video-based spasticity
assessment measurement tool could be of potential benefit in this regard.
7. To generate research knowledge on the above via Thematic Analysis of the data which will
enable insight and understanding of key issues identified.
8. To create and support opportunities to share the research knowledge generated in this
study with professional networks and neuro-rehabilitation communities throughout the UK
and globally via research presentation events and publications.
9. To enable the potential for clinical service improvement with the consideration of the
research knowledge outputs generated by this project.
10. To help create and support the building a research participant database for further
relevant research in the future
Deliverable research outputs
Research knowledge on the perceptions, opportunities and barriers experienced by patients,
carers and physician in relation to spasticity management treatment with Botulinum Toxin
injection during and post COVID-19.
Research knowledge on the factors which influence patients', carers' and physician's
individual perceptions of the risk versus benefit appraisal with regard to attending an
Out-patient spasticity clinic.
Research knowledge on what potential strategies might help support and encourage patients in
terms of communication and understanding of spasticity management
Research knowledge which establishes an evidence base of individual patient, carer and
Physician experiences, which can inform the development of best practice guidelines for
spasticity management and contribute to the design of a potential protocol to identify how
patients could be prioritised for this type of treatment during any future pandemic.
Methodology.
The investigators have adopted a qualitative approach in order to enable in-depth insight and
understanding to be gained from individual participants in order to understand participants'
own experiences and perspectives (9). The theoretical framework used is based on the adoption
of the constructivist paradigm, where it is understood that there are multiple realities,
experienced by individuals, which are all equally valid and carry meaning for the individual.
The investigators will use Thematic Analysis to organise and code the data and to enable us
to develop emergent themes based on an inductive approach (10).
Methods. Sampling and recruitment. A purposive sample of participants will be invited to take
part. These potential participants will be identified by the research team and will comprise
patients, who have attended Dr Sakel's Out-patient spasticity clinics over the last 18
months. These clinics will include both video based and in person face to face clinics.
Potential participants will meet the following eligibility criteria:
- Adults aged 18 and over
- 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.
The investigators will aim to recruit a sample of 10 potential participants (patients and
carers) and 1 Physician injector.
Study design and setting. Qualitative design with semi-structured interviews conducted by the
co-investigator by telephone. Interviews will be audio-recorded and transcribed by the
co-investigator. An interview topic guide will be used to support the structure of the
interviews.
Interviews will be scheduled with eligible participants at mutually convenient dates and
times.
It is anticipated that the length of preliminary interviews will vary depending on the
individual. Participants may be interviewed on a number of occasions at mutually convenient
times to enable in depth data gathering.
Schedule of research project time-line. Submission of protocol and documents for Ethical
Approval via IRAS and HRA - September 2021 When approval is received, the team will start
recruitment and the research. Recruitment of participants and interviews to be completed by
mid-December 2021.
Data analysis will be conducted from 01/03/2022 to 01/04/2022. Preparation of report and
abstract for potential conference submission by 30/04/2022.
