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临床试验/NCT05882097
NCT05882097进行中(未招募)不适用

Transform Randomised Control Trial in Uganda

International Care Ministries, Philippines2 个研究点 分布在 1 个国家目标入组 4,800 人开始时间: 2023年8月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
4,800
试验地点
2
主要终点
Change from baseline in EuroQol-5 Dimension - 5 levels (EQ-5D-5L) at 6 and 12 months

研究概览

简要总结

In recent decades, the poverty rate in Uganda decreased by more than half, from 56% in 1992/1993 to 21.4% in 2019/2020. However, Uganda remains as one of the poorest countries in the world. Recognising that poverty is a multifaceted issue, International Care Ministries (ICM), a non-profit organisation, implements a program called Transform to target households living in poverty from 3 dimensions: values, livelihood and health. ICM first started the Transform program in the Philippines and recently expanded to Uganda and Guatemala. The program includes 15 sessions and delivers them to the participants during the course of a 4-month period. Previously, three randomised control trials found positive impacts of Transform on certain poverty indicators in the Philippines. Although positive impacts were found in the Philippines, the effectiveness of Transform in Uganda is unknown.

详细描述

International Care Ministries (ICM) is a non-governmental organisation with a mission to reduce the burden of extreme poverty. ICM focused its work in the Philippines for more than 30 years and recently expanded to Uganda and Guatemala. The core poverty alleviation program at ICM is called Transform. Transform focuses on improving values, health and livelihood through a 15-week program (1 lesson per week). ICM has conducted three randomized controlled trials (RCT) in the Philippines. This RCT was designed in response to the expansion of ICM's work in Uganda. Realising the poverty issue that was exacerbated by the COVID-19 pandemic, ICM implemented its first Transform program in Uganda in 2020. As of May 2023, more than 210 communities and 5,921 participants received the Transform program in the regions of Kiboga and Kyankwanzi. Despite the fact that previous RCTs found a positive impact of Transform on certain poverty indicators in the Philippines, the effectiveness of Transform is not known in another context. The Philippines and Uganda are vastly different in terms of their economies, cultures and demographics. This study builds on the previous RCTs and aims to evaluate the Transform program on measures of economic outcomes, social capital, health, hope and spiritual well-being in a different context. Whether there will be similar results in Uganda will deepen perspectives in the universal elements of success that can be further adopted and scaled up in other countries. While a key challenge in poverty alleviation initiatives is the lack of high quality evidence to evaluate the effectiveness of programs, this study will use the gold standard of effectiveness research - RCT, to deepen understanding in the causal impact of the Transform program in another context.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

The participants will not know which group they belong to. Due to procedures to implement the study, it is inevitable that the operations team will know who will belong to the control and treatment arms (control participants will not receive the Transform program). This study will be a single masked study.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Poverty score of 50 and above in the Philippine Poverty Score Card Survey qualifies the person into Transform. Higher score indicates poorer households.
  • Only the top 30 poorest household will be selected once the community gets approve to host the Transform program.

排除标准

  • Participants who are above the threshold using the poverty score card (less than 50) will be excluded from the study.
  • Households also cannot participate in the study if they have previously received the Transform program, unless the implementation team overrides the score due to specific circumstances that only affect a minority of participants.

结局指标

主要结局

Change from baseline in EuroQol-5 Dimension - 5 levels (EQ-5D-5L) at 6 and 12 months

时间窗: Baseline, 6 and 12 months

The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Values are anchored at 1 (full health) and 0 (a state as bad as being dead). Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. Higher value indicate better health state.

Change from baseline in poverty probability index at 6 and 12 months

时间窗: Baseline, 6 and 12 months

The Poverty Probability Index (PPI®) is a poverty measurement tool for organizations and businesses with a mission to serve the poor. The answers to 10 questions about a household's characteristics and asset ownership are scored to compute the likelihood ranged from 0 to 1 to indicate how likely the household is living below the poverty line. The higher the probability means that more likely the household is poor.

次要结局

  • Change from baseline in duckworth index at 6 and 12 months(Baseline, 6 and 12 months)

研究者

发起方
International Care Ministries, Philippines
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lincoln Lau

Director of Research

International Care Ministries, Philippines

研究点 (2)

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