Cardiovascular DiseasemHealthNCT02913339
mHealth Interventions to Improve Access and Coverage of Uninsured People With High Cardiovascular Risk in Argentina.
A study testing mHealth Risk Assessment in people with Cardiovascular Disease, run by Brigham and Women's Hospital at 1 site in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- mHealth Risk Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- 1 siteArgentina
- Study dates
- 24 Aug 2016to 29 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
IECS- Instituto de Efectividad Clínica y Sanitaria
Buenos Aires, Buenos Aires, C1414CPT
About this study
Official title: MHealth Interventions to Improve Access and Coverage of Uninsured People With High Cardiovascular Risk in Argentina.
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- mHealth Risk Assessment
- Keywords
- screening, telemedicine, risk assessment, prevention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Risk AssessmentOther
Using mobile phone application to calculate CVD risk and to schedule interviews at local government clinics.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: mHealth Risk Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start24 Aug 2016
- Primary completion25 Aug 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Clinical Effectiveness and Health Policy
- Responsible party
- Principal investigator, Thomas A Gaziano, Brigham and Women's Hospital
- Investigators
- Thomas A Gaziano, MD, MSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913339
- Sponsor's protocol ID
- 2015P002360
- Acronym
- mHealth
- Status last verified
- Aug 2024
- First submitted
- 21 Sep 2016
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33769555Beratarrechea 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.
PubMed 30943824
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MHealth Interventions to Improve Access and Coverage of Uninsured People With High Cardiovascular Risk in Argentina.
- ClinicalTrials.gov ID
- NCT02913339
- Acronym / sponsor ID
- mHealth / 2015P002360
- Conditions
- Cardiovascular Disease
- Keywords
- screening, telemedicine, risk assessment, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Institute for Clinical Effectiveness and Health Policy
- Study start
- 24 Aug 2016 (actual)
- Primary completion
- 25 Aug 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: mHealth Risk AssessmentCommunity 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. |
| Control | Active comparator | Other: mHealth Risk AssessmentThe 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth Risk AssessmentUsing mobile phone application to calculate CVD risk and to schedule interviews at local government clinics. | Other | Control, Intervention |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Derived from this study: PubMed 33769555Palmer 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.
- Derived from this study: PubMed 30943824Beratarrechea 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas A Gaziano, MD, MSc principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Risk Assessment in people with Cardiovascular Disease, run by Brigham and Women's Hospital at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02913339, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.