Effectiveness of Financial Incentives and Text Messages to Improve Health Care in Population With Moderate and High Cardiovascular Risk

Moderate and High Cardiovascular Risk Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03300154
• Other study ID #: AR-T1087-P0001/2
• Status: Active, not recruiting
• Phase: N/A
• First received: September 28, 2017
• Last updated: October 2, 2017
• Start date: April 27, 2017
• Est. completion date: October 23, 2017

Study information

• Verified date: September 2017
• Source: Institute for Clinical Effectiveness and Health Policy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 917
• Est. completion date: October 23, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Moderate and High Cardiovascular Risk

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Argentina	1º DE MAYO	Guemes	Salta
Argentina	Barrio Cooperativa	Guemes	Salta
Argentina	Barrio La Tablada	Guemes	Salta
Argentina	Campo Santo	Guemes	Salta
Argentina	CIC	Guemes	Salta
Argentina	EL BORDO	Guemes	Salta
Argentina	El cruce	Guemes	Salta
Argentina	Villa Tranquila	Guemes	Salta
Argentina	Los Olivos	Güemes	Salta

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Clinical Effectiveness and Health Policy	Inter-American Development Bank

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance at the first medical visit	Proportion of patients who attended and completed the first clinical visit to the health center	4 weeks
Primary	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	Attendance at least one clinical visit	Proportion of patients who attended and completed at least one clinical visit to the health	12 weeks