此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Effectiveness of Financial Incentives and Text Messages to Improve Health Care in Population With Moderate and High Cardiovascular Risk

Effectiveness of Financial Incentives and Text Messages to Improve Health Care of Vulnerable Population With Moderate and High Cardiovascular Risk in Argentina: A Randomized Cluster Trial

Cardiovascular diseases are increasing throughout the developing world and are the cause of almost 16.7 million deaths each year, of which 80% occur in low and middle-income countries. As more than three fourth of the global burden of cardiometabolic diseases are related to risk factors connected with lifestyles or behaviors, such as smoking, unhealthy eating, low physical activity, and harmful consumption of alcohol. This burden could be dramatically reduced by changing individual behaviors. This study is focused on interventions that are aimed to improve the adherence to treatment in cardiovascular disease (hypertension), based on a Behavioral Economics approach. Most of public policies targeted to tackle NCDs utilize a rational economic model of behavior. Behavioral economics, by using insights from cognitive psychology and other social sciences, has drawn a lot of attention for its potential to increase healthy behaviors. Interventions informed by BE principles seek to rearrange the social or physical environment in such a way to 'nudge' people towards healthier choices and behaviors.

Main objective: to assess whether the implementation of two strategies based on behavioral economics, that include the use of a financial incentive scheme and specific framing to beneficiaries (i.e. mobile health interventions), increase the referral, evaluation and follow-up of people with moderate and high cardiovascular risk in the public health network, compared to the usual strategy.

Design: A cluster-randomized pragmatic clinical trial will be performed. The randomization unit will be the Community Health Centers (CHC) and the intervention groups (2 arms) or control will be assigned to 9 health centers in total (3 CHC per arm).

Population: This RCT is going to be conducted in selected CHC of Salta. Nine CHC will be selected, which will be randomized: 3 centers to the control, 3 centers to framing intervention with messages and 3 centers to the intervention with incentives.

A total of 900 patients ≥ 40 years, without health coverage and with a 10-year cardiovascular risk ≥ 10% will participate in this study.

Follow up: 3 month

研究概览

研究类型

介入性

注册 (实际的)

917

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Salta
      • Guemes、Salta、阿根廷、4400
        • 1º DE MAYO
      • Guemes、Salta、阿根廷、4400
        • Barrio Cooperativa
      • Guemes、Salta、阿根廷、4400
        • Barrio La Tablada
      • Guemes、Salta、阿根廷、4400
        • Campo Santo
      • Guemes、Salta、阿根廷、4400
        • CIC
      • Guemes、Salta、阿根廷、4400
        • EL BORDO
      • Guemes、Salta、阿根廷、4400
        • El cruce
      • Guemes、Salta、阿根廷、4400
        • Villa Tranquila
      • Güemes、Salta、阿根廷、4400
        • Los Olivos

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Subjects that only have public health coverage.
  • Residence in the area of influence of the health centers of the study.
  • Have a mobile phone for personal use.
  • 10 year cardiovascular risk ≥ 10%

Exclusion Criteria:

  • Pregnant women.
  • Immobilized people.
  • Persons who do not give their informed consent.
  • People planning to move in the next 3 months

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:日常护理
实验性的:Financial incentives
The study nurses will schedule an appointment with the doctor at the health center, within 4 weeks from the participant's inclusion in the study. Participants who attend the first visit at the health center will receive a direct incentive consisting of the payment of a limited amount to be determined (approximately AR $ 150-200) through a shopping voucher for the amount mentioned. Participants attending the follow-up visit at the health center within 3 months from their inclusion in the study will participate in a lottery. The lottery will offer the possibility of winning a new voucher with a probability of 1 in 3. Participants who do not attend the health center will not receive any incentive.
实验性的:Framing (SMS)
After inclusion, participants will receive weekly text messages (SMS) using a specific framing or formulation of the message, highlighting the potential benefits and positive aspects of health care. These messages will promote follow-up visits, adherence to treatment, and benefits to be gained from a follow-up visit with the physician. Messages will be sent with a frequency of two per week during the first 30 days and then 1 per week until the end of the follow-up. These messages will have no cost to participants.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Attendance at the first medical visit
大体时间:4 weeks
Proportion of patients who attended and completed the first clinical visit to the health center
4 weeks
Attendance at the second medical visit
大体时间:8 weeks after first medical visit
Proportion of patients who attended and completed the second clinical visit to the health center
8 weeks after first medical visit

次要结果测量

结果测量
措施说明
大体时间
Attendance at least one clinical visit
大体时间:12 weeks
Proportion of patients who attended and completed at least one clinical visit to the health
12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年4月27日

初级完成 (实际的)

2017年7月31日

研究完成 (预期的)

2017年10月23日

研究注册日期

首次提交

2017年9月28日

首先提交符合 QC 标准的

2017年10月2日

首次发布 (实际的)

2017年10月3日

研究记录更新

最后更新发布 (实际的)

2017年10月3日

上次提交的符合 QC 标准的更新

2017年10月2日

最后验证

2017年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • AR-T1087-P0001/2

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅