Use of Mobile Technology to Prevent Progression of Pre-hypertension in Latin American Urban Settings
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Purpose
Nearly half of the adult population in Latin American urban settings has abnormally high blood pressure. Although half of these subjects with high blood pressure are still in the pre-hypertensive stage (systolic blood pressure values in the 120-139 mmHg range or diastolic blood pressure in the 80-89 mmHg range), the rate of progression to hypertension is high (10-20% per year), according to studies done in other settings. The main objective of this proposal is to evaluate the effectiveness of an affordable and sustainable primary health care intervention to reduce blood pressure and prevent progression from pre-hypertensive status to hypertension in individuals at poor urban clinics in Argentina, Guatemala, and Peru. Our primary hypotheses are that pre-hypertensive subjects who receive mHealth (mobile health) support for 12 months (intervention group) will have lower blood pressure compared to individuals who receive the usual primary health care (control group); and that pre-hypertensive subjects will maintain lower blood pressure six months after receiving mHealth support. The investigators will determine the effects of an intervention using mHealth technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants. The intervention also aims to help participants become better informed, motivated, and encouraged to practice self-management of their own health; to improve patient satisfaction levels; provide tailored targeted interventions; and to improve patient-provider relationships. The proposal is designed as a proof-of-concept intervention in three Latin American countries that encompass a wide range of environments and health care settings. A total of 212 subjects (30-60 years old) per country will be recruited in primary health clinics and randomized to study groups. Blood pressure, anthropometry, and behavioral risk factors (physical activity, diet, stress, alcohol and tobacco use) will be measured at baseline and at months 6 and 12 during the intervention, and six months after the end of the intervention. The investigators will also evaluate feasibility, acceptability, cost-effectiveness, and process implementation of the intervention.
| Condition | Intervention |
|---|---|
|
Hypertension Prehypertension |
Behavioral: Mobile technology to promote lifestyle modification |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Mobile Health to Prevent Progression of Pre-hypertension in Latin American Urban Settings |
- Change from Baseline in Systolic Blood Pressure at 6, 12, and 18 months [ Time Frame: 6, 12, and 18 months ] [ Designated as safety issue: No ]A reduction in systolic blood pressure is expected as early as 6 months of intervention and this reduction is kept or even continue to decrease over time
- Change from Baseline in Diastolic Blood Pressure at 6, 12, and 18 months [ Time Frame: 6, 12, and 18 months ] [ Designated as safety issue: No ]A reduction in diastolic blood pressure is expected as early as 6 months of intervention and this reduction is kept or even continue to decrease over time
| Estimated Enrollment: | 636 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention
Pre-hypertensive subjects who receive mHealth support for 12 months
|
Behavioral: Mobile technology to promote lifestyle modification
Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants
|
|
No Intervention: Control
Individuals who receive the usual primary health care
|
Eligibility| Ages Eligible for Study: | 30 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Systolic blood pressure values in the 120-139 mmHg range or diastolic blood pressure in the 80-89 mmHg range
- No current anti-hypertensive medication
- Own a personal cellular phone
Exclusion Criteria:
- Previous diagnosis/treatment hypertension
- Illiteracy
- Another household member already in the study
Contacts and Locations| Argentina | |
| Institute for Clinical Effectiveness and Health Policy | |
| Buenos Aires, Argentina | |
| Guatemala | |
| Insitute of Nutrition of Central America and Panama | |
| Guatemala, Guatemala, 01011 | |
| Peru | |
| Universidad Peruana Cayetano Heredia | |
| Lima, Peru | |
More Information
No publications provided
| Responsible Party: | Manuel Ramirez-Zea, Head, INCAP Comprehensive Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama |
| ClinicalTrials.gov Identifier: | NCT01295216 History of Changes |
| Other Study ID Numbers: | HHSN268200900028C |
| Study First Received: | February 11, 2011 |
| Last Updated: | March 31, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Institute of Nutrition of Central America and Panama:
|
prehypertension blood pressure mobile technology Latin America |
behavioral change healthy lifestyles mHealth |
Additional relevant MeSH terms:
|
Hypertension Prehypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013