Brief 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. 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

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

917

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach

1 country

9 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

Study Start

First participant enrolled

April 27, 2017

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2017

Completed

5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed

20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2017

Completed

Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

3 months

First QC Date

September 28, 2017

Last Update Submit

October 2, 2017

Conditions

Moderate and High Cardiovascular Risk

Keywords

Cardiovascular riskBehavioral economicsText messagesFinancial incentives

Outcome Measures

Primary Outcomes (2)

Attendance at the first medical visit
Proportion of patients who attended and completed the first clinical visit to the health center
4 weeks
Attendance at the second medical visit
Proportion of patients who attended and completed the second clinical visit to the health center
8 weeks after first medical visit

Secondary Outcomes (1)

Attendance at least one clinical visit
12 weeks

Study Arms (3)

Financial incentives

EXPERIMENTAL

Behavioral: Financial incentives

Framing (SMS)

EXPERIMENTAL

Behavioral: Framing (SMS)

Usual care

NO INTERVENTION

Interventions

Financial incentivesBEHAVIORAL

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.

Financial incentives

Framing (SMS)BEHAVIORAL

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.

Framing (SMS)

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
year cardiovascular risk ≥ 10%

You may not qualify if:

Pregnant women.
Immobilized people.
Persons who do not give their informed consent.
People planning to move in the next 3 months

Contact the study team to confirm eligibility.