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临床试验/NCT02913339
NCT02913339已完成不适用

MHealth Interventions to Improve Access and Coverage of Uninsured People With High Cardiovascular Risk in Argentina.

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 756 人开始时间: 2016年8月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
756
试验地点
2
主要终点
Impact of mHealth app on rate of uninsured persons who are at risk and attend a first visit with a health professional at a local government primary care clinic.

研究概览

简要总结

Cardiovascular disease (CVD) accounts for approximately one-third of Argentina's deaths. Despite the availability of management and treatment for CVD which is offered to the uninsured population at government primary care clinics (PCCs), the rates at which those at risk are screened, identified and referred to the clinics are very low. This study will determine if providing CHWs with an mHealth application using an integrated, inexpensive and validated screening tool on cell phones for screening in the community which is linked with the PCC scheduling system wirelessly allowing the CHWs to make appointments at the time they identify high-risk individuals, will increase the number of referral and follow-up visits that patients attend at the PCCs.

详细描述

Cardiovascular disease (CVD) is a leading cause of death in Argentina where death rates have continued to rise along with risk factors for CVD. Challenges to control in low- and middle income countries (LMIC) include low awareness, shortages of trained health care workers, overcrowded primary care centers (PCCs), and overall lack of resources in health care systems. Determining ways to increase screening in community settings and efficient referral to PCCs is a significant priority in reducing the CVD burden in Argentina. Previous work funded by the NIH shows that effective low-cost screening tools are available, CHWs can be trained to use a validated, simple non-lab based screening tool in communities to identify those at high CVD risk, and use of a mobile phone application for this tool reduced both the cost of training and screening time for CHWs. What has not been shown is whether persons at high risk for CVD can be appropriately referred for proper evaluation, treatment, and effective management of CVD at the PCCs. The Ministry of Health in Argentina has instituted an incentive system through the REDES Program that has the goal of increasing the number of uninsured who are at high risk for CVD are screened, identified, referred, and provided with appropriate care and treatment with essential diagnostics and medicines. The investigators propose to develop a mHealth tool that integrates the cell phone application for the risk screening tool to be wirelessly and directly connected with the electronic scheduling systems at PCCs. This will allow CHWs to access the appointment scheduling system at the government clinics, allowing them to make appointments for the identified high-risk individuals at the time of screening to increase the number of referral and follow-up visits that these individuals attend. This integrated scheduling system will allow for text messaging to be used to remind patients of their appointments and to schedule followup care. Finally, the system will be integrated with the electronic record system at the PCC so that ongoing monitoring and evaluation of the program can be implemented. The investigators propose a pragmatic cluster randomized trial in which individual PCCs will be randomized to either to use of the integrated mHealth tool, or usual screening procedures using existing paper based screening. The objectives will be to determine if use of the mHealth tool increases the number of high-risk persons who show up for the referral visits, if it increases the rate of subsequent follow-up care visits for the referred persons, and the cost-effectiveness of the intervention.

研究设计

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

入排标准

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

入选标准

  • Uninsured subjects aged 2:40 years who live in the catchment area of the participating primary care clinics with a mobile for personal use and a 10-year CVD risk of;:;: 10%, as classified by a community health worker.

排除标准

  • Pregnant women, bed-bound illiterate and persons who cannot give informed consent, or are planning to move away from the vicinity of the clinic in the following year will be excluded.

结局指标

主要结局

Impact of mHealth app on rate of uninsured persons who are at risk and attend a first visit with a health professional at a local government primary care clinic.

时间窗: 6 weeks

Proportion of patients with a 10-year CVD risk ≥ 10% that have successfully completed the baseline (first) visit to a clinic out of all those classified as having risk \>10% within the prior 6 weeks in the community.

次要结局

  • Impact of mHealth app on rate of uninsured persons who are at risk and attend a follow-up visit, after baseline, with a health professional at a local government primary care clinic.(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas A Gaziano

Director, Global CVD Health Policy and Prevention Unit

Brigham and Women's Hospital

研究点 (2)

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