Clinical trial NCT02913339: mHealth Interventions to Improve Access and Coverage of Uninsured People With High Cardiovascular Risk in Argentina.
Official title: MHealth Interventions to Improve Access and Coverage of Uninsured People With High Cardiovascular Risk in Argentina.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: screening
telemedicine
risk assessment
prevention
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Institute for Clinical Effectiveness and Health Policy
First posted: 2016-09-23
Enrollment: 756
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Detailed description: Cardiovascular disease (CVD) is a leading cause of death in Argentina where death rates have continued to rise along with risk factors for CVD. Challenges to control in low- and middle income countries (LMIC) include low awareness, shortages of trained health care workers, overcrowded primary care centers (PCCs), and overall lack of resources in health care systems. Determining ways to increase screening in community settings and efficient referral to PCCs is a significant priority in reducing the CVD burden in Argentina. Previous work funded by the NIH shows that effective low-cost screening tools are available, CHWs can be trained to use a validated, simple non-lab based screening tool in communities to identify those at high CVD risk, and use of a mobile phone application for this tool reduced both the cost of training and screening time for CHWs. What has not been shown is whether persons at high risk for CVD can be appropriately referred for proper evaluation, treatment, and effective management of CVD at the PCCs. The Ministry of Health in Argentina has instituted an incentive system through the REDES Program that has the goal of increasing the number of uninsured who are at high risk for CVD are screened, identified, referred, and provided with appropriate care and treatment with essential diagnostics and medicines. The investigators propose to develop a mHealth tool that integrates the cell phone application for the risk screening tool to be wirelessly and directly connected with the electronic scheduling systems at PCCs. This will allow CHWs to access the appointment scheduling system at the government clinics, allowing them to make appointments for the identified high-risk individuals at the time of screening to increase the number of referral and follow-up visits that these individuals attend. This integrated scheduling system will allow for text messaging to be used to remind patients of their appointments and to schedule followup care. Finally, the system will be integrated with the electronic record system at the PCC so that ongoing monitoring and evaluation of the program can be implemented. The investigators propose a pragmatic cluster randomized trial in which individual PCCs will be randomized to either to use of the integrated mHealth tool, or usual screening procedures using existing paper based screening. The objectives will be to determine if use of the mHealth tool increases the number of high-risk persons who show up for the referral visits, if it increases the rate of subsequent follow-up care visits for the referred persons, and the cost-effectiveness of the intervention.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: 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.
timeFrame: 6 weeks
Secondary outcomes:
measure: 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.
timeFrame: 4 months
Other outcomes:
measure: 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.
timeFrame: 6-12 months
Locations:
city: Buenos Aires
country: Argentina
facility: IECS- Instituto de Efectividad Clínica y Sanitaria
state: Buenos Aires Province
Study officials:
affiliation: Brigham and Women's Hospital
name: Thomas A Gaziano, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.