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

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ClinicalTrials.gov Identifier: NCT02913339
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
Institute for Clinical Effectiveness and Health Policy
Information provided by (Responsible Party):
Thomas A Gaziano, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Other: mHealth Risk Assessment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 756 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: MHealth Interventions to Improve Access and Coverage of Uninsured People With High Cardiovascular Risk in Argentina.
Actual Study Start Date : August 24, 2016
Actual Primary Completion Date : August 25, 2017
Actual Study Completion Date : December 29, 2017

Arm Intervention/treatment
Experimental: Intervention
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
Using mobile phone application to calculate CVD risk and to schedule interviews at local government clinics.

Active Comparator: Control

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




Primary Outcome Measures :
  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. [ Time Frame: 6 weeks ]
    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.


Secondary Outcome Measures :
  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. [ Time Frame: 4 months ]
    Proportion of patients with a 10-year CVD risk ≥ 10% that have successful completed the follow-up visit to a clinic within 4 months of the baseline visit out of all those classified as having risk >10% in the community.


Other Outcome Measures:
  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. [ Time Frame: 6-12 months ]
    3. Proportion of patients who are on chronic medications for respective conditions and have a 5-year CVD risk ≥ 10% (i.e.Antihypertensives if systolic blood pressure (SBP)> 140 mmHg or Statins if CVD risk ≥ 20%).



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

uninsured subjects aged ≥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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913339


Locations
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Argentina
IECS- Instituto de Efectividad Clínica y Sanitaria
Buenos Aires, Buenos Aires Province, Argentina, C1414CPT
Sponsors and Collaborators
Brigham and Women's Hospital
Institute for Clinical Effectiveness and Health Policy
Investigators
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Principal Investigator: Thomas A Gaziano, MD, MSc Brigham and Women's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas A Gaziano, Director, Global CVD Health Policy and Prevention Unit, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02913339    
Other Study ID Numbers: 2015P002360
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Keywords provided by Thomas A Gaziano, Brigham and Women's Hospital:
screening
telemedicine
risk assessment
prevention
Additional relevant MeSH terms:
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Cardiovascular Diseases