Reducing Cardiovascular Risk in Primary Care: a Randomized Clinical Trial (Misalud)

September 27, 2022 updated by: Pontificia Universidad Catolica de Chile

Effectiveness of a Gamified App for Cardiovascular Disease Management in Primary Care: a Randomized Clinical Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

Cardiovascular disease is still a major 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. According to the Chilean National Health Survey the population with moderate and high cardiovascular risk in Chile is 25.5%.

In Chile, 80% of the population holds public health insurance and are beneficiaries of the public health care network at no co-payment. Chile has a strong primary care network. Most of its population is registered in primary care clinics and receives clinical and preventive services for free.

Control of cardiovascular risk factors such as physical activity, hypertension, and diabetes has been insufficient in Chile. Only 20% of the population with moderate or high cardiovascular risk reported adequate levels of physical activity. In addition, only 50% of the population with hypertension reaches adequate blood pressure levels and only 30% of the population with diabetes is well controlled. These insufficient standards are associated with low adherence to pharmacological therapies that do not reach the level of 50% even though medications are free of cost for this population in primary care.

There is evidence that the use of mobile applications can improve cardiovascular disease control in at-risk patients. However, there is a lack of information on the type of best application models (e.g informative, interactive, gamification-based), and on their applicability and effectiveness in real primary care settings. There is some evidence that gamified-based applications are superior that informative or interactive models. There are no well-designed trials in Latin America testing the effectiveness of gamification-based application in reducing cardiovascular risk in primary care patients.

Hypothesis:

Null hypothesis: The use of a gamification-based mobile application in primary care patients does not improve their level of physical activity and medication adherence compared to standard care.

Alternative hypothesis: The use of a gamification-based mobile application in primary care patients improves their level of physical activity and medication adherence compared to standard care.

General Objective:

This project aims to reduce cardiovascular risk in a population with moderate and high-risk levels by developing a mobile interactive application based on gamification that could integrate self-control with clinical management in primary care.

Specific Objectives:

To improve by 30% the level of physical activity in a population with moderate or high cardiovascular risk patients through the use of a new gamification-based mobile application.

To improve by 30% the level of medication adherence in a population of moderate and high cardiovascular risk patients through the use of a new gamification-based mobile application.

To develop a usable, reliable, and safe gamification-based mobile application for primary care patients.

To achieve at least a 66%% of weekly usability rate of the new gamification-based mobile application.

Procedures:

Data sources The trial will be conducted in three primary care clinics in Santiago (La Pintana), Talca (San Clemente) and Concepción (Chiguayante). Primary baseline data will be obtained from personal interviews conducted to a group of 900 participants selected from a random sample of patients with moderated or high cardiovascular risk registered in each primary care clinic. Clinical baseline data will be obtained from electronic charts from the same group of patients using a standardized instrument. All participants will have a basic panel of lab tests that define their cardiovascular risk and are included in the national cardiovascular program as part of their usual care. Half of the participants will complete a 6-minute walk test (6MWT) to assess their aerobic capacity and exercise tolerance. A final survey, clinical assessment, and 6MWT will be conducted at the end of the trial to the same participants.

Data Dictionary:

Primary outcome:

  • Level of physical activity: Intensity and frequency of physical activity measured through the International Physical Activity Questionnaire (IPAQ).
  • Medication adherence: The extent to which patients comply with medical indications on drug doses and frequency. It will be estimated using the internationally validated "Adherence to Refills and Medications scale" (ARMS)

Secondary outcomes:

  • Cardiovascular risk level: Probability of developing a cardiovascular event ( cerebrovascular, heart, blood vessel disease) during the next five years. According to the Chilean National Guidelines based on the Framingham score.
  • High Blood Pressure: An abnormal and persistent elevation of blood pressure defined as systolic levels of 140 mm Hg or higher or diastolic levels of 90 mm Hg or higher.
  • Diabetes: A metabolic disorder defined as levels of HbA1c levels >= 6.5%, or fasting plasma glucose >= 126 mg/dl, or an oral glucose tolerance test or random plasma glucose level > = 200 mg/dl
  • Lipid disorder: A metabolic disorder defined as a total blood cholesterol level ≥ 200 mg/dL, LDL cholesterol < 130, HDL cholesterol > 50 mg/dl and trygglicerides < 200 mg/dl
  • Smoking: current smoker defined as an adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes.
  • Sedentarism: Sedentary life style defined as a level of physical activity lower that 150 minutes per week of moderate aerobic activity.

Registry Baseline and final information gathered directly from participants, electronic charts and 6MWT will be registered in the Research Electronic Data Capture software (Redcap). Redcap is the licensed institutional metadata EDC software used by the Research Center at PUC for clinical trials. Registration will be conducted by an independent assistant team at PUC and will not be accessible to the research team.

In addition, a process information system will be developed based on a tracking form for registering recruitment, intervention compliance, and final evaluation of the study population.

Quality assurance/data check The Chilean National Research Agency (ANID), which is the funding agency for this project, requires researchers to report regularly all steps of the project and any changes that are needed during the process. To assuring a standard report, ANIS required the Principal Investigator to register the information bi-monthly on a specific platform.

(https://fondefsis.conicyt.cl/cgi-bin/proyectos.php) where all relevant activities, processes, landmarks, and results are described. A tracking financial system is also included in a separate section of the platform. In addition, a research executive supervisor is designated by ANID. She has to meet bi-monthly with the research team to assure the scientific the project is developing as planned. Also, a financial supervisor is designated by ANID for assuring that the expenses of the project are in line with the approved budget and are in the correct timing.

The Institutional Review Board at PUC fully reviewed and approved all instruments and procedures conducted in the study. In addition, the whole protocol had to be reviewed and approved by local IRB local Committees in Santiago (SSMSO), Talca (SSMaule) and Concepción (SSConcepción).

A specific team from the project will be in charge of checking the data provided by the interviewers. The team will be responsible for assuring the appropriate conduction of the informed consent process, the correct application of the questionnaires and clinical chart assessment, and the accurate application and registration of the 6MWT. In addition, a random sample of 5% of the interviews will be re-checked to assure correct application. All interviewers will be checked. In case of detection of false data, all interviews conducted by the particular interviewer will have to be repeated.

Sample size:

The sample size was estimated based on the magnitude of the changes expected to achieve after the intervention in the two primary outcomes of the study i.e. level of physical activity and adherence to medication therapy. The sample size was estimated for each clinic independently.

The level of physical activity was based on information provided by the National Health Survey (2017) and the National Survey on Physical Activity (2018). According to this information, the study considered an improvement of at least 30% (i.e 18% to 25%) in the population physically active when comparing the intervention vs. the control group.

Adherence to medical therapy parameters for the population with moderate to high cardiovascular risk in Chile was based on national studies of primary care patients conducted in Chile. According to this information, the study considered a relative improvement of at least 30% (i.e from 50% to 65%) in the level of adherence to medication therapy in the intervention vs. the control group in each clinic. This level of medication therapy adherence is clinically significant for reducing cardiovascular disease in high-risk populations.

The study was designed to achieve a power of 0.8 (i.e. 20% of type II error) to show significant differences between intervention and control groups in each clinic and with a type I error (alfa level) of 0.05 (two-sided test). Based on these parameters, we estimated a sample size of 127 participants per group to detect significant differences in the level of physical activity and 113 participants in each group for detecting significant differences in levels of medication adherence. We estimated an attrition rate of 10% of the population during the study, and therefore, the final sample size was set at 300 participants percenter (150 participants in each group) Missing data: An intention to treat analysis will be conducted as the primary model of the study analysis. Therefore, the primary analysis will consider no change in study variables among participants with missing data. A single imputation method using the mean substitution technique will also be conducted to test the magnitude of the effect of missing data in the final outcome. Sensitivity analysis of these methods will be conducted.

Statistical analysis The data from the study will be collected and registered in the Research Electronic Data Capture (RedCap) platform. Descriptive and analytic statistics will be conducted using IBM-SPSS software professional version. Univariate and multivariate analysis will be conducted to test the association and potential confounder variables between the intervention model and the primary and secondary outcomes considered. A logistic regression model will be applied to analyze categorical variables such as level of physical activity, level of medication adherence, or level of cardiovascular risk changes pre and post-intervention between groups. The model will adjust for potential confounding variables in case there are significant differences in critical variables (e.g. education level) at baseline. A multiple linear regression model will be used for the analysis of continuous variables such as changes in cardiovascular risk scores or Met-min/week scores between groups before and after the intervention. Results of the study will be reported using the CONSORT criteria.

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile, 8820000
        • Primary Care Clinic Santiago (La Pintana-Ch)
    • Concepción
      • Chiguayante, Concepción, Chile, 4100000
        • Primary Care Clinic Concepción (Chiguayante-Ch)
    • Talca
      • San Clemente, Talca, Chile, 3520000
        • Primary Care Clinic, Talca (San Clemente-SC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults between 30 and 65 years old
  2. Included in the population-based registration system of primary care clinics in Santiago (La Pintana-LP), Talca (San Clemente-SC) and Concepción (Giguayante-Ch)
  3. Individuals with a moderate (10-15%) or high (>15%) cardiovascular risk level according to the National Chilean Guidelines adapted from the Framingham scale.
  4. Individuals with a personal smartphone or with access to a smartphone from a close family relative identified as caring supporters by them.

Exclusion Criteria:

  1. Adults not in the year range
  2. Adults not cognitive competent (e.g not able to answer a personal survey)
  3. Individuals with low or very low cardiovascular risk -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health App

This group will have access to a gamified App to help them to control their cardiovascular risk factors and to improve their adherence to medication therapy.

Half of the participants will be allocated to the App group. They will be stratified by age and cardiovascular risk level according to national standards based on the Framingham risk factors level.
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).
Active Comparator: Usual Care
This group will not have access to the gamified App and will receive their usual care at the primary care clinic. In addition, they will receive extra information on cardiovascular risk factors control. Both groups will have the same access to clinical checks and medications at the clinic.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in medication adherence
Time Frame: Change from baseline medication adherence at 18 months
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
Change in level of physical activity
Time Frame: Change from baseline in level of physical activity at 18 months
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
Change in functional capacity
Time Frame: Change from baseline in functional capacity at 18 months
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
Change in fatigue level
Time Frame: Change from baseline in fatigue level at 18 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardiovascular risk level
Time Frame: Change from baseline in cardiovascular risk level at 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

National Fund for Research and Development in Health, Chile

Investigators

  • Study Director: Klaus Puschel, MD,MPH,MSc, School of Medicine. Pontificia Universidad Católica de Chile
  • Principal Investigator: Julian Varas, MD, MSc, School of Medicine. Pontificia Universidad Católica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA20I0001
  • 200117003 (Other Identifier: Pontificia Universidad Católica de Chile)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All the information from the study will be available to external researchers according to the guidelines of the Chilean National Agency for Research and Development (ANID;https://www.anid.cl/) that funds the investigation.

IPD Sharing Time Frame

April 2024-April 2027

IPD Sharing Access Criteria

Written consent from the Research Director or Principal Investigator Written consent from the Chilean National Agency for Research and Development (ANID)

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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