mHealth Interventions to Improve Access and Coverage of Uninsured People With High Cardiovascular Risk in Argentina.

NCT02913339 | Completed DMC

• 1 other identifier: 2015P002360
• Study Type: interventional
• Target: 756
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease (CVD) accounts for approximately one-third of Argentina's deaths. Despite the availability of management and treatment for CVD which is offered to the uninsured population at government primary care clinics (PCCs), the rates at which those at risk are screened, identified and referred to the clinics are very low. This study will determine if providing CHWs with an mHealth application using an integrated, inexpensive and validated screening tool on cell phones for screening in the community which is linked with the PCC scheduling system wirelessly allowing the CHWs to make appointments at the time they identify high-risk individuals, will increase the number of referral and follow-up visits that patients attend at the PCCs.

Conditions

Cardiovascular Disease

Keywords

screening; telemedicine; risk assessment; prevention

Outcome Measures

Primary Outcomes (1)

• Impact of mHealth app on rate of uninsured persons who are at risk and attend a first visit with a health professional at a local government primary care clinic.

  Proportion of patients with a 10-year CVD risk ≥ 10% that have successfully completed the baseline (first) visit to a clinic out of all those classified as having risk \>10% within the prior 6 weeks in the community.

  6 weeks

Secondary Outcomes (1)

• Impact of mHealth app on rate of uninsured persons who are at risk and attend a follow-up visit, after baseline, with a health professional at a local government primary care clinic.

  4 months

Other Outcomes (1)

• Impact of mHealth app on rate of uninsured persons who are at risk and have treatment initiated by a health professional at the government primary care clinics.

  6-12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Community health workers (CHWs) will conduct screening for CVD risk using a mobile phone application to assess risk and to schedule appointments at primary care centers (PCCs). The screening process will be non-invasive and no surgical, pharmaceutical, or other testing procedures will be utilized for screening of CVD risk by CHWs. If the CHW calculates the risk of CVD to be \> 10%, s/he will schedule a clinical visit with a health professional at one of the PCCs for further assessment and/or appropriate treatment. An automatic reminder messaging system will send reminder messages about upcoming appointments to the participants.

Other: mHealth Risk Assessment

Control

ACTIVE COMPARATOR

The protocol will be identical to that implemented in the intervention arm with the following difference: If the CHW calculates the risk of CVD to be \> 10%, s/he will verbally advise the study participant of her/his increased risk and recommend that s/he schedule a clinical visit with a health professional at one of the PCCs for further assessment and/or appropriate treatment.

Other: mHealth Risk Assessment

Interventions

mHealth Risk Assessment OTHER

Using mobile phone application to calculate CVD risk and to schedule interviews at local government clinics.

Control; Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Uninsured subjects aged 2:40 years who live in the catchment area of the participating primary care clinics with a mobile for personal use and a 10-year CVD risk of;:;: 10%, as classified by a community health worker.

You may not qualify if:

• Pregnant women, bed-bound illiterate and persons who cannot give informed consent, or are planning to move away from the vicinity of the clinic in the following year will be excluded.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Institute for Clinical Effectiveness and Health Policy: collaborator

Study Sites (1)

IECS- Instituto de Efectividad Clínica y Sanitaria

Buenos Aires, Buenos Aires, C1414CPT, Argentina

Location

Related Publications (2)

• Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.

  PMID: 33769555 DERIVED

• Beratarrechea A, Abrahams-Gessel S, Irazola V, Gutierrez L, Moyano D, Gaziano TA. Using mH ealth Tools to Improve Access and Coverage of People With Public Health Insurance and High Cardiovascular Disease Risk in Argentina: A Pragmatic Cluster Randomized Trial. J Am Heart Assoc. 2019 Apr 16;8(8):e011799. doi: 10.1161/JAHA.118.011799.

  PMID: 30943824 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Thomas A Gaziano, MD, MSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Global CVD Health Policy and Prevention Unit

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 23, 2016
• Study Start: August 24, 2016
• Primary Completion: August 25, 2017
• Study Completion: December 29, 2017
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

AR (1)