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临床试验/NCT04082091
NCT04082091Unknown不适用

Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention in PakisTan(SELECT) - A Pilot Feasibility Study Using mHealth

Aga Khan University0 个研究点目标入组 2,000 人开始时间: 2019年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
主要终点
Health Service Delivery of Intervention Outreach via Interactive Voice Recording

研究概览

简要总结

We will evaluate an e_Prescription intervention can be integrated into an electronic screening program, which together exploit: (i) reach - the adult population has 100% mobile phone ownership and 92% internet national coverage; and (ii) behavioral change - the intervention can teach verbally and visually, thus bypassing literacy challenges, to allow simple, low-cost, repetition messaging for habit reinforcement. Uptake of the program through the various stages will be evaluated in ~2000 adults of a large representative suburban district of Karachi: As well as before-and-after physiological measures, including blood pressure (BP) and blood glucose, a random sample of 30-40 participants will be invited for interview to assess success and failure of the program. This is a pragmatic feasibility intervention implementation study.

详细描述

The goal of this pilot study is to demonstrate feasibility of a scalable , population-wide, approach to early detection and management of people at high-risk of CVD using electronic screening, referral, treatment and lifestyle modification based on health theory and considerable background research for local applicability.

It is a mixed method, feasibility study based in Malir District of Karachi, the largest city in Pakistan, to demonstrate uptake, participation and response of our mHealth intervention.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

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

  • All adult (>18 years) residents of Malir district
  • Own a mobile phone
  • Provide written informed consent are eligible to participate

排除标准

  • Not permanent residents of Malir district.
  • A person who is decision impaired due to stroke, or aphasia or dementia .
  • Serious cognitive deficits that impair the visualization or understanding of SMS, IVR and e_prescription messages

结局指标

主要结局

Health Service Delivery of Intervention Outreach via Interactive Voice Recording

时间窗: 3 to 6 months

Number of IVR ( Interactive Voice Recording ) sent to target Population

Health Service Delivery of Intervention Outreach via Short Text Messages

时间窗: 3 to 6 months

The success rate in delivery of SMS intervention to target community 1. Number of SMS sent successfully to target Population

Health Service Measures of Intervention Uptake

时间窗: 3 to 6 months

Proportion of referred participants enrolled in e_Prescription education program

Early Impact Measure of Intervention for Prompt Referral

时间窗: 3 to 6 months

Proportion of referred participants from screened participants referred

Community Participation and Uptake of Intervention

时间窗: 3 to 6 months

Number of participants responded to the IVR and SMS call

Early Impact Measure of Intervention for Detection

时间窗: 3 to 6 months

Proportion of participants in each of risk strata (low, medium and high risk) as defined by the presence of stroke and/or MI ( High ), DM and / or HTN ( Medium), or poor lifestyle choices ( Low Risk) by the SELECT algorithm

次要结局

  • Change in Physiological Characteristics of Intervention Participants - Blood Pressure(0, 3 to 6 months)
  • Change in Physiologic Characteristics of Intervention Participants- Height(0, 3 to 6 months)
  • Change in Physiological Characteristics of Intervention Participants - Physical Activity(0, 3 to 6 months)
  • Change in Physiological Characteristics of Intervention Participants - Weight(0, 3 to 6 months)
  • Change in Physiological Characteristics of Intervention Participants - BMI(0, 3 to 6 months)

研究者

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

Dr. Ayeesha Kamran Kamal

Professor of Neurology, Department of Medicine

Aga Khan University

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