Reducing Cardiovascular Risk in Primary Care: a Randomized Clinical Trial

Summary

Cardiovascular disease is a leading cause of death and disease in Chile. It explains 27.6% of the causes of death and 14% of disabled adjusted life years in the Chilean population. Low levels of physical activity and low levels of adherence to pharmacological therapy are major risk factors for cardiovascular disease in at-risk populations. This project will design and test the effectiveness of a mobile application based on gamification theory for improving cardiovascular disease control in a population of 900 primary care patients with moderate or high cardiovascular risk levels. A randomized controlled trial was designed to test the effect of the App in improving 30% of the levels of physical activity and adherence to pharmacological therapy and a significant reduction of 20% in cardiovascular risk levels.

Conditions

• Cardiovascular Diseases
• Compliance, Medication
• Physical Inactivity
• Hypertension
• Diabetes Mellitus
• Lipid Disorder

Interventions

OTHER

Health App

The intervention will include training health teams and patients in accessing and using a gamified health App 2-3 times a week. The App is based on a gamified character that improves its health if a patient checks its App, complies with her therapy, does regular exercise, and introduces normal levels of blood pressure, lipids level, and HbA1c levels. On the other hand, the character gets sick if the patient does not comply with her therapy or does not achieve certain levels of physical activity (i.e. 30 min moderate exercise 5 times a week or 2.5 hs a week or more than 9000 steps/day).

OTHER

Usual Care

In this group, participants will receive their usual cardiovascular care according to the national guidelines. All patients receive free care at the primary care clinics and also receive free medications prescribed according to the national guidelines at the clinics. In addition, participants in this group will receive specific written information to improve their medication compliance, level of physical activity, blood pressure, HbA1c, and lipids level control.

Sponsors & Collaborators

• National Fund for Research and Development in Health, Chile

  collaborator OTHER

• Pontificia Universidad Catolica de Chile

  lead OTHER

Principal Investigators

• Klaus Puschel, MD,MPH,MSc · School of Medicine. Pontificia Universidad Católica de Chile

• Julian Varas, MD, MSc · School of Medicine. Pontificia Universidad Católica de Chile

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2023-05-30

Completion

2024-02-01

Countries

• Chile

Study Locations