Reducing Cardiovascular Risk in Primary Care: a Randomized Clinical Trial

NCT05395806 | Unknown

• 2 other identifiers: SA20I0001200117003
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Change in cardiovascular risk level

  Change from baseline in cardiovascular risk level at 18 months

Study Arms (2)

Health App

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Health App OTHER

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).

Health App

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• National Fund for Research and Development in Health, Chile: collaborator

Study Sites (3)

Primary Care Clinic Concepción (Chiguayante-Ch)

Chiguayante, Concepción, 4100000, Chile

Location

Primary Care Clinic, Talca (San Clemente-SC)

San Clemente, Talca, 3520000, Chile

Location

Primary Care Clinic Santiago (La Pintana-Ch)

Santiago, 8820000, Chile

Location

Related Publications (12)

• Yusuf S, Joseph P, Rangarajan S, Islam S, Mente A, Hystad P, Brauer M, Kutty VR, Gupta R, Wielgosz A, AlHabib KF, Dans A, Lopez-Jaramillo P, Avezum A, Lanas F, Oguz A, Kruger IM, Diaz R, Yusoff K, Mony P, Chifamba J, Yeates K, Kelishadi R, Yusufali A, Khatib R, Rahman O, Zatonska K, Iqbal R, Wei L, Bo H, Rosengren A, Kaur M, Mohan V, Lear SA, Teo KK, Leong D, O'Donnell M, McKee M, Dagenais G. Modifiable risk factors, cardiovascular disease, and mortality in 155 722 individuals from 21 high-income, middle-income, and low-income countries (PURE): a prospective cohort study. Lancet. 2020 Mar 7;395(10226):795-808. doi: 10.1016/S0140-6736(19)32008-2. Epub 2019 Sep 3.

  PMID: 31492503 BACKGROUND

• Fernando L, Pamela S, Alejandra L. Cardiovascular disease in Latin America: the growing epidemic. Prog Cardiovasc Dis. 2014 Nov-Dec;57(3):262-7. doi: 10.1016/j.pcad.2014.07.007. Epub 2014 Aug 4.

  PMID: 25443823 BACKGROUND

• Varleta P, Akel C, Acevedo M, Salinas C, Pino J, Opazo V, Garcia A, Echegoyen C, Rodriguez D, Gramusset L, Leon S, Cofre P, Hernandez H, Neira P, Retamal R, Petit G, Moya N. [Assessment of adherence to antihypertensive therapy]. Rev Med Chil. 2015 May;143(5):569-76. doi: 10.4067/S0034-98872015000500003. Spanish.

  PMID: 26203567 BACKGROUND

• Valencia-Monsalvez F, Mendoza-Parra S, Luengo-Machuca L. [Evaluation of Morisky medication adherence scale (mmas-8) in older adults of a primary health care center in Chile]. Rev Peru Med Exp Salud Publica. 2017 Apr-Jun;34(2):245-249. doi: 10.17843/rpmesp.2017.342.2206. Spanish.

  PMID: 29177383 BACKGROUND

• Perez-Jover V, Sala-Gonzalez M, Guilabert M, Mira JJ. Mobile Apps for Increasing Treatment Adherence: Systematic Review. J Med Internet Res. 2019 Jun 18;21(6):e12505. doi: 10.2196/12505.

  PMID: 31215517 BACKGROUND

• Kripalani S, Risser J, Gatti ME, Jacobson TA. Development and evaluation of the Adherence to Refills and Medications Scale (ARMS) among low-literacy patients with chronic disease. Value Health. 2009 Jan-Feb;12(1):118-23. doi: 10.1111/j.1524-4733.2008.00400.x.

  PMID: 19911444 BACKGROUND

• Seron P, Munoz S, Lanas F. [Levels of physical activity in an urban population from Temuco, Chile]. Rev Med Chil. 2010 Oct;138(10):1232-9. Epub 2011 Jan 10. Spanish.

  PMID: 21279268 BACKGROUND

• Bansilal S, Castellano JM, Garrido E, Wei HG, Freeman A, Spettell C, Garcia-Alonso F, Lizano I, Arnold RJ, Rajda J, Steinberg G, Fuster V. Assessing the Impact of Medication Adherence on Long-Term Cardiovascular Outcomes. J Am Coll Cardiol. 2016 Aug 23;68(8):789-801. doi: 10.1016/j.jacc.2016.06.005.

  PMID: 27539170 BACKGROUND

• Du L, Cheng Z, Zhang Y, Li Y, Mei D. The impact of medication adherence on clinical outcomes of coronary artery disease: A meta-analysis. Eur J Prev Cardiol. 2017 Jun;24(9):962-970. doi: 10.1177/2047487317695628. Epub 2017 Jan 1.

  PMID: 28436725 BACKGROUND

• Alvarado L. [Adherence to treatment in chronic diseases and the patient's experience]. Rev Med Chil. 2016 Feb;144(2):269-70. doi: 10.4067/S0034-98872016000200019. No abstract available. Spanish.

  PMID: 27092685 BACKGROUND

• Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017 Jul 4;167(1):40-47. doi: 10.7326/M17-0046. Epub 2017 Jun 20.

  PMID: 28630973 BACKGROUND

• Momany MC, Martinez-Gutierrez J, Soto M, Capurro D, Ciampi F, Thompson B, Puschel K. Development of mobile technologies for the prevention of cervical cancer in Santiago, Chile study protocol: a randomized controlled trial. BMC Cancer. 2017 Dec 13;17(1):847. doi: 10.1186/s12885-017-3870-8.

  PMID: 29237420 BACKGROUND

Related Links

• Chilean National Health Survey, 2017
• Health status indicators, Chile 2021

MeSH Terms

Conditions

Cardiovascular Diseases; Medication Adherence; Sedentary Behavior; Hypertension; Diabetes Mellitus; Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Klaus Puschel, MD,MPH,MSc

  School of Medicine. Pontificia Universidad Católica de Chile

  STUDY DIRECTOR

• Julian Varas, MD, MSc

  School of Medicine. Pontificia Universidad Católica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial- Multicenter Registered patients at three primary care clinics were randomly allocated to intervention or control groups at each clinic. The intervention group received access and technical supprot for using a new App to help improve their control vs control group that received general information and usual care.

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 27, 2022
• Study Start: January 1, 2021
• Primary Completion: May 30, 2023
• Study Completion: February 1, 2024
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: April 2024-April 2027
• Access Criteria: Written consent from the Research Director or Principal Investigator Written consent from the Chilean National Agency for Research and Development (ANID)

Locations

CL (3)