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临床试验/NCT05865626
NCT05865626已完成不适用

A Pilot Study to Evaluate Video Observed Treatment Among Tuberculosis Patients From Lambaréné Using an Instant Messenger Application

Centre de Recherche Médicale de Lambaréné2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年10月10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
30
试验地点
2
主要终点
feasibility assessment

研究概览

简要总结

This pilot study aimed to assess the feasibility of using an instant messenger to monitor drug intake in tuberculosis patients and to assess cash incentive to improve adherence to drug intake

详细描述

At the initial visit, the inclusion criteria are cross-checked, the subject is informed of the study procedures, and an informed consent form is signed by subjects willing to participate.

For the participants from the intervention group, the research team will provide a smartphone with the WhatsApp application to each participant. At the initial visit, the research team will explain to the participants how to use the phone and the instant messenger application for the study. Briefly, the subject is filmed while taking the drug. This can be via a "selfie" or by a family member. The video is then sent to the study phone contact.

Once the video is received by an investigator, a message will be sent back to the participant's mobile phone acknowledging receipt of the video. An investigator trained on the DOT protocol, will review the video clips to assess if the drug was taken correctly or not. A daily log is filled in to keep track of drug intake for each participant.

Participants from both the control and intervention group are seen once per month in person for follow-ups and getting new drugs. At these time points information on drug intake is gathered.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
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

  • Older than 18 years
  • Signed informed consent form
  • Living in an area with mobile phone coverage
  • Have at least 3 months of treatment remaining

排除标准

  • Not being able to use a smartphone and unlikely to learn how to

结局指标

主要结局

feasibility assessment

时间窗: at the end of study (2 years)

proportion of participants in the intervention groups who regularly send the videos throughout the follow-up.

次要结局

  • adherence to the VOT(at the end of study (2 years))
  • effect of cash incentives on adherence to the VOT(at the end of study (2 years))

研究者

发起方
Centre de Recherche Médicale de Lambaréné
申办方类型
Other
责任方
Principal Investigator
主要研究者

EDOA Jean Ronald

Dr

Centre de Recherche Médicale de Lambaréné

研究点 (2)

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