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临床试验/NCT04378296
NCT04378296已完成不适用

Economic Evaluation in Dermatology: Teledermatology Versus Conventional Monitoring of Patients in the Hospital

Antonio Lopez Villegas4 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
450
试验地点
4
主要终点
EuroQol-5Dimensions questionnaire

研究概览

简要总结

Introduction: Previous studies confirm that teledermatology allows the generation of a quick response from the specialist's consultation, reduction of unnecessary travels, early diagnosis and priority in the attention to the most urgent cases. Despite these advantages and that teledermatology has experienced exponential growth since its introduction approximately 16 years ago in Spain, in Andalusia, its use is still very limited. The objective of this project will be to carry out an analysis of the quality of life related to health, costs, cost-utility and informal care of teledermatology services in Primary Care compared to conventional monitoring carried out at the Hospital de Poniente.

Methodology: A randomized, controlled, unmasked, inter-level clinical trial (Primary Care-Hospital de Poniente) and multicentre (all health centers attached to the Poniente Health District of Almería) will be carried out with a 6-month follow-up. Patients will be assigned to the teledermatology group (experimental) or the conventional monitoring group in the hospital (control). The patients included in the experimental group will be monitored asynchronously. Baseline characteristics, number of visits to the hospital, health-related quality of life, costs, informal care and satisfaction from the perspective of the Andalusian Public Health System and patients and their caregivers will be analyzed. The generic EuroQol-5D questionnaire (EQ-5D) will be administered to assess health-related quality of life and the SKINDEX-29 quality of life dermatological questionnaire. A cost-utility analysis will be performed to assess whether tele-dermatology is cost-effective in terms of additional cost for additional quality-adjusted life years (QALYs).

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

  • Be over 18 years old.
  • Having any skin disease.
  • Accept to participate in the study.

排除标准

  • Non-dermatological disease.
  • Be participating in another study.
  • Refuse to participate in the study.

结局指标

主要结局

EuroQol-5Dimensions questionnaire

时间窗: 6 months

From -1 \[the poorest imaginable health state\] to 1 \[perfect health\]

次要结局

  • Healthcare costs(6 months)
  • Informal cost(6 months)
  • Clinical features(6 months)
  • Dermatological Quality of Life Questionnaire(6 months)
  • Health Care Communication Questionnaire(6 months)
  • In-depth interviews on the healthcare received in Primary Care centers(6 months)

研究者

发起方
Antonio Lopez Villegas
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Antonio Lopez Villegas

Principal Investigator

Universidad de Almeria

研究点 (4)

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