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Use of Mobile Technology to Prevent Progression of Pre-hypertension in Latin American Urban Settings

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Institute for Clinical Effectiveness and Health Policy
Universidad Peruana Cayetano Heredia
RAND
Information provided by (Responsible Party):
Manuel Ramirez-Zea, Institute of Nutrition of Central America and Panama
ClinicalTrials.gov Identifier:
NCT01295216
First received: February 11, 2011
Last updated: March 31, 2013
Last verified: March 2013
  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

Resource links provided by NLM:


Further study details as provided by Institute of Nutrition of Central America and Panama:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295216

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
Sponsors and Collaborators
Institute of Nutrition of Central America and Panama
Institute for Clinical Effectiveness and Health Policy
Universidad Peruana Cayetano Heredia
RAND
  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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014