Clinical trial NCT03300154: Effectiveness of Financial Incentives and Text Messages to Improve Health Care in Population With Moderate and High Cardiovascular Risk
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Moderate and High Cardiovascular Risk
Keywords: Cardiovascular risk
Behavioral economics
Text messages
Financial incentives
Lead sponsor: Institute for Clinical Effectiveness and Health Policy
Sponsor class: OTHER
Collaborators: name: Inter-American Development Bank
First posted: 2017-10-03
Enrollment: 917
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Attendance at the first medical visit
timeFrame: 4 weeks
measure: Attendance at the second medical visit
timeFrame: 8 weeks after first medical visit
Secondary outcomes:
measure: Attendance at least one clinical visit
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guemes
country: Argentina
facility: 1º DE MAYO
state: Salta
city: Guemes
country: Argentina
facility: Barrio Cooperativa
state: Salta
city: Guemes
country: Argentina
facility: Barrio La Tablada
state: Salta
city: Guemes
country: Argentina
facility: Campo Santo
state: Salta
city: Guemes
country: Argentina
facility: CIC
state: Salta
city: Guemes
country: Argentina
facility: EL BORDO
state: Salta
city: Guemes
country: Argentina
facility: El cruce
state: Salta
city: Guemes
country: Argentina
facility: Villa Tranquila
state: Salta
city: Güemes
country: Argentina
facility: Los Olivos
state: Salta
Study officials:
References:
citation: 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.