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临床试验/NCT05897905
NCT05897905招募中不适用

A Feasibility Study Investigating an Early, Personalised, Follow-up Programme for People After Minor Stroke

Imperial College Healthcare NHS Trust1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Recruitment rate

研究概览

简要总结

The goal of this feasibility study is to ascertain if this follow-up programme of care can feasibly be implemented within a healthcare system with people after minor stroke.

The main feasibility questions are:

i) To establish recruitment uptake ii) To establish treatment adherence iii) To determine participant retention. Participants will be randomly allocated to the intervention and control group. Those in the intervention group will receive a follow-up telephone call at two weeks after discharge and a second follow-up appointment at six weeks after discharge. Outcome measures will be taken at twelve weeks after discharge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • Adult ≥18
  • Clinical or radiological diagnosis of minor stroke from a stroke consultant.
  • Admitted to HASU or seen in rapid assessment/TIA clinic.
  • Pre-admission mRS of 0-3 with no formal package of care prior to stroke.
  • Discharge mRS of 0-
  • No onward referral to community therapy team or for package of care.
  • Has capacity to consent.

排除标准

  • Any serious co-morbidities that would impact a person's ability to participate in the follow-up appointments and outcome measurement.
  • Insufficient English to engage in intervention and outcome measures and no family or friends to support with this.
  • Not resident in England.
  • Pregnant women.

结局指标

主要结局

Recruitment rate

时间窗: Baseline

Proportion of participants randomised relative to the total number meeting the inclusion criteria.

Treatment completion rate

时间窗: 6 weeks post randomisation

Proportion of participants who attend both follow-up appointments

Retention rate

时间窗: 12 weeks post randomisation

Proportion of participants that complete the follow-up questionnaires

次要结局

  • Health Care Climate Questionnaire Short Form(Baseline and 12 weeks)
  • PROMIS10(2 weeks and 12 weeks)
  • MOCA(Baseline and 12 weeks)
  • PHQ9(12 weeks)
  • GAD7(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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