- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03300154
Effectiveness of Financial Incentives and Text Messages to Improve Health Care in Population With Moderate and High Cardiovascular Risk
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Salta
-
Guemes, Salta, Argentina, 4400
- 1º DE MAYO
-
Guemes, Salta, Argentina, 4400
- Barrio Cooperativa
-
Guemes, Salta, Argentina, 4400
- Barrio La Tablada
-
Guemes, Salta, Argentina, 4400
- Campo Santo
-
Guemes, Salta, Argentina, 4400
- CIC
-
Guemes, Salta, Argentina, 4400
- EL BORDO
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Guemes, Salta, Argentina, 4400
- El cruce
-
Guemes, Salta, Argentina, 4400
- Villa Tranquila
-
Güemes, Salta, Argentina, 4400
- Los Olivos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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%
Exclusion Criteria:
- Pregnant women.
- Immobilized people.
- Persons who do not give their informed consent.
- People planning to move in the next 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
|
|
Experimental: Financial incentives
|
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.
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 weeks
|
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
|
8 weeks after first medical visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attendance at least one clinical visit
Time Frame: 12 weeks
|
Proportion of patients who attended and completed at least one clinical visit to the health
|
12 weeks
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AR-T1087-P0001/2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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