跳至主要内容
临床试验/NCT05435404
NCT05435404已完成不适用

A Qualitative Research Study Into Patient, Carer and Physician Experiences of Spasticity Management Via Botulinum Toxin Treatment During and Post COVID-19 Pandemic. Perceptions, Opportunities and Barriers

East Kent Hospitals University NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2021年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Interview with participant

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Interview with participant

时间窗: 1 month

Telephone interview between member of research team and participant

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验