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临床试验/NCT02557542
NCT02557542终止不适用

Pilot Randomised Controlled Trial Evaluating the Potential Benefit of a One Stop Vein Clinic (OSVeC)

Imperial College London1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
1
主要终点
Quality of Life Using EuroQoL EQ-5D

研究概览

简要总结

A pilot randomised controlled trial looking at the setting up of a one stop vein clinic for the treatment of varicose veins and assessing the quality-adjusted life years at 3 months of patients This will be a pilot study which is designed to provide enough information for a potentially larger multicentre randomised controlled study.

详细描述

OBJECTIVES

  • Primary Objective

o Measure the quality-adjusted life years (QALY) gained at 3 months (using EuroQoL's EQ-5D) & AVVQ by patients randomised to treatment in the One Stop Vein Clinic with patients randomised to treatment in the normal care pathway

  • Secondary Objective

  • Patient satisfaction with the service provided using the Picker patient experience questionnaire both post-operatively and at the 3 months follow-up (One Stop Vein Clinic versus Normal Care Pathway)

  • Measure and compare the quality of life scores using CIVIQ at 0 and 3 months in patients randomised to treatment in the One Stop Vein Clinic with patients randomised to the Normal Care Pathway

  • Record the time from referral to treatment (RTT)

  • Assess the cost-effectiveness of the One Stop Vein clinic compared to the normal care pathway

  • Record the time to return to normal activities and to work

  • Assess the estimated societal costs

BACKGROUND Varicose veins are very common conditions, affecting approximately 25% of the population. Over 35,000 varicose vein procedures are currently carried out in the UK. However, with the new 2013 NICE guidelines, the Department of Health has estimated that this is set to increase to 50,000 per year. Waiting for varicose vein interventions has been shown to be detrimental to the severity of the condition and the quality of life of patients. Progression of varicose veins can also lead to complications such as leg ulcerations and can be costly to the health service. Over the past decade, new endovenous techniques have been introduced and these are felt to be cost-effective, especially, when performed in an outpatient or 'office-based' setting. At present, patients referred to the Vascular unit for consideration of management of their varicose veins have to attend the outpatient clinic at least twice prior to be listed for their procedure.

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

  • Adults over the age of 18 years
  • Unilateral lower limb symptoms suggestive of venous disease on the referral letter

排除标准

  • Recurrent varicose veins
  • Known arterial disease or ABPI<0.8
  • Current deep vein thrombosis
  • Patients who withdraw their consent
  • Inability to complete the questionnaire or attend follow up appointments
  • Currently enrolled in other venous study

研究组 & 干预措施

One Stop Vein Clinic

Experimental

Patients randomised to this group will be invited to the One Stop Vein Clinic, offering same day diagnosis and treatment

干预措施: One Stop Vein Clinic (Other)

One Stop Vein Clinic

Experimental

Patients randomised to this group will be invited to the One Stop Vein Clinic, offering same day diagnosis and treatment

干预措施: Radiofrequency ablation (Device)

One Stop Vein Clinic

Experimental

Patients randomised to this group will be invited to the One Stop Vein Clinic, offering same day diagnosis and treatment

干预措施: Endovenous laser ablation (Device)

One Stop Vein Clinic

Experimental

Patients randomised to this group will be invited to the One Stop Vein Clinic, offering same day diagnosis and treatment

干预措施: Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate) (Drug)

Normal Care Pathway

Active Comparator

Patients randomised to this group will be invited to the Normal Care Pathway

干预措施: One Stop Vein Clinic (Other)

Normal Care Pathway

Active Comparator

Patients randomised to this group will be invited to the Normal Care Pathway

干预措施: Radiofrequency ablation (Device)

Normal Care Pathway

Active Comparator

Patients randomised to this group will be invited to the Normal Care Pathway

干预措施: Endovenous laser ablation (Device)

Normal Care Pathway

Active Comparator

Patients randomised to this group will be invited to the Normal Care Pathway

干预措施: Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate) (Drug)

结局指标

主要结局

Quality of Life Using EuroQoL EQ-5D

时间窗: 3 months

Quality of life using the EuroQoL EQ-5D scale which is a generic quality of life score. Minimum score = -0.073 (worse) and maximum score is 1.0 (best).

次要结局

  • Patient Satisfaction(3 months)
  • Generic Quality of Life Scores Using EQ-5D Questionnaire(3 months)
  • Specific Quality of Life Scores Using AVVQ(3 months)
  • Time From Referral to Treatment(18 weeks)
  • Measure the Cost of the One Stop Vein Clinic Compared to the Normal Care Pathway(3 months)
  • Report the Time to Return to Normal Activities and to Work(1 month)
  • Measure the Societal Costs of the One Stop Vein Clinic(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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