Moderate and High Cardiovascular RiskNCT03300154
Effectiveness of Financial Incentives and Text Messages to Improve Health Care in Population With Moderate and High Cardiovascular Risk
A study testing Financial incentives and Framing (SMS) in people with Moderate and High Cardiovascular Risk, run by Institute for Clinical Effectiveness and Health Policy at 9 sites in Argentina.
Trial summary
Cardiovascular diseases are increasing throughout the developing world and are the cause of almost 16.7 million deaths each year, of which 80% occur in low and middle-income countries. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Moderate and High Cardiovascular Risk
- What is being tested?
- Financial incentives and Framing (SMS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 917 participants
- Where
- 9 sitesArgentina
- Study dates
- 27 Apr 2017to 23 Oct 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects that only have public health coverage.
- Residence in the area of influence of the health centers of the study.
- Have a mobile phone for personal use.
- 10 year cardiovascular risk ≥ 10%
Who cannot join
- Pregnant women.
- Immobilized people.
- Persons who do not give their informed consent.
- People planning to move in the next 3 months
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Argentina9 sites
1º DE MAYO
General Guemes, Salta Province, 4400
Barrio Cooperativa
General Guemes, Salta Province, 4400
Barrio La Tablada
General Guemes, Salta Province, 4400
Campo Santo
General Guemes, Salta Province, 4400
CIC
General Guemes, Salta Province, 4400
EL BORDO
General Guemes, Salta Province, 4400
El cruce
General Guemes, Salta Province, 4400
Los Olivos
General Guemes, Salta Province, 4400
Villa Tranquila
General Guemes, Salta Province, 4400
About this study
Official title: Effectiveness of Financial Incentives and Text Messages to Improve Health Care of Vulnerable Population With Moderate and High Cardiovascular Risk in Argentina: A Randomized Cluster Trial
Cardiovascular diseases are increasing throughout the developing world and are the cause of almost 16.7 million deaths each year, of which 80% occur in low and middle-income countries. As more than three fourth of the global burden of cardiometabolic diseases are related to risk factors connected with lifestyles or behaviors, such as smoking, unhealthy eating, low physical activity, and harmful consumption of alcohol. This burden could be dramatically reduced by changing individual behaviors. This study is focused on interventions that are aimed to improve the adherence to treatment in cardiovascular disease (hypertension), based on a Behavioral Economics approach. Most of public policies targeted to tackle NCDs utilize a rational economic model of behavior. Behavioral economics, by using insights from cognitive psychology and other social sciences, has drawn a lot of attention for its potential to increase healthy behaviors. Interventions informed by BE principles seek to rearrange the social or physical environment in such a way to 'nudge' people towards healthier choices and behaviors.
Main objective: to assess whether the implementation of two strategies based on behavioral economics, that include the use of a financial incentive scheme and specific framing to beneficiaries (i.e. mobile health interventions), increase the referral, evaluation and follow-up of people with moderate and high cardiovascular risk in the public health network, compared to the usual strategy.
Read more
Design: A cluster-randomized pragmatic clinical trial will be performed. The randomization unit will be the Community Health Centers (CHC) and the intervention groups (2 arms) or control will be assigned to 9 health centers in total (3 CHC per arm).
Population: This RCT is going to be conducted in selected CHC of Salta. Nine CHC will be selected, which will be randomized: 3 centers to the control, 3 centers to framing intervention with messages and 3 centers to the intervention with incentives.
A total of 900 patients ≥ 40 years, without health coverage and with a 10-year cardiovascular risk ≥ 10% will participate in this study.
Follow up: 3 month
- Conditions
- Moderate and High Cardiovascular Risk
- Being tested
- Financial incentives, Framing (SMS)
- Keywords
- Cardiovascular risk, Behavioral economics, Text messages, Financial incentives
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial incentivesBehavioural
The study nurses will schedule an appointment with the doctor at the health center, within 4 weeks from the participant's inclusion in the study. Participants who attend the first visit at the health center will receive a direct incentive consisting of the payment of a limited amount to be determined (approximately AR $ 150-200) through a shopping voucher for the amount mentioned. Participants attending the follow-up visit at the health center within 3 months from their inclusion in the study will participate in a lottery. The lottery will offer the possibility of winning a new voucher with a probability of 1 in 3. Participants who do not attend the health center will not receive any incentive.
Framing (SMS)Behavioural
After inclusion, participants will receive weekly text messages (SMS) using a specific framing or formulation of the message, highlighting the potential benefits and positive aspects of health care. These messages will promote follow-up visits, adherence to treatment, and benefits to be gained from a follow-up visit with the physician. Messages will be sent with a frequency of two per week during the first 30 days and then 1 per week until the end of the follow-up. These messages will have no cost to participants.
| Study group | Role | What they receive |
|---|---|---|
| Financial incentives | Experimental | Not described Receives: Behavioral: Financial incentives |
| Framing (SMS) | Experimental | Not described Receives: Behavioral: Framing (SMS) |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance at the first medical visit
Proportion of patients who attended and completed the first clinical visit to the health center
Measured: 4 weeks
Attendance at the second medical visit
Proportion of patients who attended and completed the second clinical visit to the health center
Measured: 8 weeks after first medical visit
Secondary outcomes (1)
Attendance at least one clinical visit
Proportion of patients who attended and completed at least one clinical visit to the health
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start27 Apr 2017
- Primary completion31 Jul 2017
- Study completion23 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate and High Cardiovascular RiskStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 917 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Effectiveness and Health Policy
- Sponsor type
- University, hospital or other
- Collaborators
- Inter-American Development Bank
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300154
- Sponsor's protocol ID
- AR-T1087-P0001/2
- Status last verified
- Sep 2017
- First submitted
- 28 Sep 2017
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Poggio R, Prado C, Santero M, Nejamis A, Gutierrez L, Irazola V. Effectiveness of financial incentives and message framing to improve clinic visits of people with moderate-high cardiovascular risk in a vulnerable population in Argentina: A cluster randomized trial. Prev Med. 2021 Dec;153:106738. doi: 10.1016/j.ypmed.2021.106738. Epub 2021 Jul 20.
PubMed 34298028
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Financial Incentives and Text Messages to Improve Health Care of Vulnerable Population With Moderate and High Cardiovascular Risk in Argentina: A Randomized Cluster Trial
- ClinicalTrials.gov ID
- NCT03300154
- Acronym / sponsor ID
- AR-T1087-P0001/2
- Conditions
- Moderate and High Cardiovascular Risk
- Keywords
- Cardiovascular risk, Behavioral economics, Text messages, Financial incentives
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 917 participants (actual)
- Lead sponsor
- Institute for Clinical Effectiveness and Health PolicyUniversity, hospital or other
- Collaborators
- Inter-American Development Bank
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 23 Oct 2017 (estimated)
- First posted
- 3 Oct 2017 (actual)
- 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 diseases are increasing throughout the developing world and are the cause of almost 16.7 million deaths each year, of which 80% occur in low and middle-income countries. As more than three fourth of the global burden of cardiometabolic diseases are related to risk factors connected with lifestyles or behaviors, such as smoking, unhealthy eating, low physical activity, and harmful consumption of alcohol. This burden could be dramatically reduced by changing individual behaviors. This study is focused on interventions that are aimed to improve the adherence to treatment in cardiovascular disease (hypertension), based on a Behavioral Economics approach. Most of public policies targeted to tackle NCDs utilize a rational economic model of behavior. Behavioral economics, by using insights from cognitive psychology and other social sciences, has drawn a lot of attention for its potential to increase healthy behaviors. Interventions informed by BE principles seek to rearrange the social or physical environment in such a way to 'nudge' people towards healthier choices and behaviors.
Main objective: to assess whether the implementation of two strategies based on behavioral economics, that include the use of a financial incentive scheme and specific framing to beneficiaries (i.e. mobile health interventions), increase the referral, evaluation and follow-up of people with moderate and high cardiovascular risk in the public health network, compared to the usual strategy.
Design: A cluster-randomized pragmatic clinical trial will be performed. The randomization unit will be the Community Health Centers (CHC) and the intervention groups (2 arms) or control will be assigned to 9 health centers in total (3 CHC per arm).
Population: This RCT is going to be conducted in selected CHC of Salta. Nine CHC will be selected, which will be randomized: 3 centers to the control, 3 centers to framing intervention with messages and 3 centers to the intervention with incentives.
A total of 900 patients ≥ 40 years, without health coverage and with a 10-year cardiovascular risk ≥ 10% will participate in this study.
Follow up: 3 month
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Financial incentives | Experimental | Behavioral: Financial incentives |
| Framing (SMS) | Experimental | Behavioral: Framing (SMS) |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects that only have public health coverage.
- Residence in the area of influence of the health centers of the study.
- Have a mobile phone for personal use.
- 10 year cardiovascular risk ≥ 10%
Key exclusion criteria (4 listed)
- Pregnant women.
- Immobilized people.
- Persons who do not give their informed consent.
- People planning to move in the next 3 months
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 |
|---|---|---|
| Financial incentivesThe study nurses will schedule an appointment with the doctor at the health center, within 4 weeks from the participant's inclusion in the study. Participants who attend the first visit at the health center will receive a direct incentive consisting of the payment of a limited amount to be determined (approximately AR $ 150-200) through a shopping voucher for the amount mentioned. Participants attending the follow-up visit at the health center within 3 months from their inclusion in the study will participate in a lottery. The lottery will offer the possibility of winning a new voucher with a probability of 1 in 3. Participants who do not attend the health center will not receive any incentive. | Behavioural | Financial incentives |
| Framing (SMS)After inclusion, participants will receive weekly text messages (SMS) using a specific framing or formulation of the message, highlighting the potential benefits and positive aspects of health care. These messages will promote follow-up visits, adherence to treatment, and benefits to be gained from a follow-up visit with the physician. Messages will be sent with a frequency of two per week during the first 30 days and then 1 per week until the end of the follow-up. These messages will have no cost to participants. | Behavioural | Framing (SMS) |
Primary outcome
Attendance at the first medical visit
Time frame: 4 weeks
Proportion of patients who attended and completed the first clinical visit to the health center
Attendance at the second medical visit
Time frame: 8 weeks after first medical visit
Proportion of patients who attended and completed the second clinical visit to the health center
1 secondary outcome
Attendance at least one clinical visit
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Derived from this study: PubMed 34298028Poggio R, Prado C, Santero M, Nejamis A, Gutierrez L, Irazola V. Effectiveness of financial incentives and message framing to improve clinic visits of people with moderate-high cardiovascular risk in a vulnerable population in Argentina: A cluster randomized trial. Prev Med. 2021 Dec;153:106738. doi: 10.1016/j.ypmed.2021.106738. Epub 2021 Jul 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial incentives and Framing (SMS) in people with Moderate and High Cardiovascular Risk, run by Institute for Clinical Effectiveness and Health Policy at 9 sites 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Results are not available in the source record.
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?
Attendance at the first medical visit (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT03300154, which also lists 1 linked publication.
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 3 Oct 2017.