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临床试验/NCT03095339
NCT03095339已完成不适用

EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2011年2月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Human active cysticercosis cumulative incidence

研究概览

简要总结

This is a pre-post randomized community-based controlled trial aimed at estimating the effectiveness of an educational package developed using PRECEDE PROCEED to reduce the cumulative incidence of Taenia solium cysticercosis in three Provinces of Burkina Faso. The study design included an 18-months baseline study to measure baseline cumulative incidence of cysticercosis followed by an 18-month post randomization study to measure the effectiveness of the intervention. Sixty villages of three Provinces of Burkina Faso were included. The primary outcome was the change in the baseline to post randomization cumulative incidence in the intervention group compared to the control group.

研究设计

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

入排标准

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

入选标准

  • Population of at least 1000 at the 2006 census
  • Present on the map of the "Institut Géographique du Burkina 2000"
  • Separated from another village by at least 5 kilometers.

排除标准

  • Village located on a National or Provincial road
  • Village located within 20 km of Koudougou or Ouagadougou
  • Regional or Provincial Capital
  • Absence of pigs in the village
  • At the individual level, the following eligibility criteria were used:
  • Inclusion Criteria:
  • Aged 5 years old or more
  • Has lived in the village for at least 12 months
  • Not planning to move in the next three years
  • Exclusion Criteria:
  • Presence of confirmed epilepsy or progressively worsening severe chronic headaches at baseline.

研究组 & 干预措施

Educational package

Active Comparator

The educational package included the offering of the Self-Esteem , Associative strengths, Resourcefulness, Action-planning and Responsibility (SARAR) Participatory Hygiene and Sanitation Transformation (PHAST) approach, a 52 minutes educational movie and accompanying cartoon booklet. The package was developed using the PRECEDE approach.

干预措施: Educational package (Other)

Control

No Intervention

The control group did not receive any intervention

结局指标

主要结局

Human active cysticercosis cumulative incidence

时间窗: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization

Sero conversion to the AgELISA test to detect antigens of cysticercosis

次要结局

  • Porcine active cysticercosis prevalence(baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization)
  • Change in knowledge, attitude and practices(baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization)
  • Stigmatization of epilepsy(18 months follow-up post randomization)
  • Cumulative incidence of epilepsy and progressively worsening severe chronic headaches(baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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