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

I

Institute of Nutrition of Central America and Panama

Status

Terminated

Conditions

Hypertension
Prehypertension

Treatments

Behavioral: Mobile technology to promote lifestyle modification

Study type

Interventional

Funder types

Other

Identifiers

NCT01295216
HHSN268200900028C

Details and patient eligibility

About

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.

Enrollment

637 patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

637 participants in 2 patient groups

Intervention
Experimental group
Description:
Pre-hypertensive subjects who receive mHealth support for 12 months
Treatment:
Behavioral: Mobile technology to promote lifestyle modification
Control
No Intervention group
Description:
Individuals who receive the usual primary health care

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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