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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05395806
Other study ID # SA20I0001
Secondary ID 200117003
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date February 1, 2024

Study information

Verified date September 2022
Source Pontificia Universidad Catolica de Chile
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


Description:

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Study Design


Intervention

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).
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.

Locations

Country Name City State
Chile Primary Care Clinic Concepción (Chiguayante-Ch) Chiguayante Concepción
Chile Primary Care Clinic, Talca (San Clemente-SC) San Clemente Talca
Chile Primary Care Clinic Santiago (La Pintana-Ch) Santiago

Sponsors (2)

Lead Sponsor Collaborator
Pontificia Universidad Catolica de Chile National Fund for Research and Development in Health, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (12)

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Outcome

Type Measure Description Time frame Safety issue
Primary Change in medication adherence Compliance with pharmacologic therapy estimated using the the Adherence to Refills and Medications Scale (ARMS). Unit of Measure : Scale units (Score 12 to 28 units) Change from baseline medication adherence at 18 months
Primary Change in level of physical activity The level of physical activity (vigorous, moderate, mild) of participants will be estimated based on the International Physical Questionnaire (IPAQ) which expresses the energy expended by individuals in MET/min/week. Unit of Measure: MET-minutes/week Change from baseline in level of physical activity at 18 months
Primary Change in functional capacity The functional capacity of a random sample of 50% (450) of participants will be estimated based on the 6-minute walk test. Unit of Measure: Meters Change from baseline in functional capacity at 18 months
Primary Change in fatigue level The level of fatigue and dyspnea will be estimated using the Borg Scale, which is a component of the 6-minute walk test. Unit of Measure: Scale units (Score: 0 to 10 units) Change from baseline in fatigue level at 18 months
Secondary Change in cardiovascular risk level Cardiovascular risk level of the participant population will be estimated according to the National Chilean Guidelines of Cardiovascular Disease for Primary Care that is based on the Framingham studies. Unit of measure: risk percentage at 10 years (% at 10 years) Change from baseline in cardiovascular risk level at 18 months
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