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No significant change for the primary objective at 12 months
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| Name | Class |
|---|---|
| Institute for Clinical Effectiveness and Health Policy | OTHER |
| Universidad Peruana Cayetano Heredia | OTHER |
| RAND | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Pre-hypertensive subjects who receive mHealth support for 12 months |
|
| Control | No Intervention | Individuals who receive the usual primary health care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile technology to promote lifestyle modification | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months | A reduction in systolic and diastolic blood pressure is expected as early as 6 months of intervention and it is expected that this reduction is maintained or even continue to decrease over time | Baseline, 6, 12, and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Food Intake at 12 Months | Baseline and 12 months | |
| Change From Baseline in Body Weight at 12 Months | Baseline and 12 months | |
| Change From Baseline in Body Mass Index at 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Clinical Effectiveness and Health Policy | Buenos Aires | Argentina | ||||
| Insitute of Nutrition of Central America and Panama |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32314970 | Derived | Bernabe-Ortiz A, Pauschardt J, Diez-Canseco F, Miranda JJ. Sustainability of mHealth Effects on Cardiometabolic Risk Factors: Five-Year Results of a Randomized Clinical Trial. J Med Internet Res. 2020 Apr 21;22(4):e14595. doi: 10.2196/14595. | |
| 30389646 | Derived | Carrillo-Larco RM, Jiwani SS, Diez-Canseco F, Kanter R, Beratarrechea A, Irazola V, Ramirez-Zea M, Rubinstein A, Martinez H, Miranda JJ; GISMAL Group. Implementation Tells Us More Beyond Pooled Estimates: Secondary Analysis of a Multicountry mHealth Trial to Reduce Blood Pressure. JMIR Mhealth Uhealth. 2018 Nov 1;6(11):e10226. doi: 10.2196/10226. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Pre-hypertensive subjects who receive mHealth support for 12 months 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 |
| FG001 | Control | Individuals who receive the usual primary health care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Pre-hypertensive subjects who receive mHealth support for 12 months 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Systolic and Diastolic Blood Pressure at 6, 12, and 18 Months | A reduction in systolic and diastolic blood pressure is expected as early as 6 months of intervention and it is expected that this reduction is maintained or even continue to decrease over time | Posted | Mean | 95% Confidence Interval | mmHg | Baseline, 6, 12, and 18 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Pre-hypertensive subjects who receive mHealth support for 12 months 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manuel Ramirez-Zea | Institute of Nutrition of Central America and Panama | +502 24719913 | mramirez@incap.int |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Baseline and 12 months |
| Change From Baseline in Waist Circumference at 12 Months | Baseline and 12 months |
| Change From Baseline in Physical Activity at 12 Months | Baseline and 12 months |
| Guatemala City |
| 01011 |
| Guatemala |
| Universidad Peruana Cayetano Heredia | Lima | Peru |
| 26653067 | Derived | Rubinstein A, Miranda JJ, Beratarrechea A, Diez-Canseco F, Kanter R, Gutierrez L, Bernabe-Ortiz A, Irazola V, Fernandez A, Letona P, Martinez H, Ramirez-Zea M; GISMAL group. Effectiveness of an mHealth intervention to improve the cardiometabolic profile of people with prehypertension in low-resource urban settings in Latin America: a randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Jan;4(1):52-63. doi: 10.1016/S2213-8587(15)00381-2. Epub 2015 Dec 1. |
| BG001 |
| Control |
Individuals who receive the usual primary health care |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Individuals who receive the usual primary health care |
|
|
|
| Secondary | Change From Baseline in Food Intake at 12 Months | Posted | Mean | 95% Confidence Interval | Servings/day | Baseline and 12 months |
|
|
|
| Secondary | Change From Baseline in Body Weight at 12 Months | Posted | Mean | 95% Confidence Interval | kg | Baseline and 12 months |
|
|
|
| Secondary | Change From Baseline in Body Mass Index at 12 Months | Posted | Mean | 95% Confidence Interval | kg/m2 | Baseline and 12 months |
|
|
|
| Secondary | Change From Baseline in Waist Circumference at 12 Months | Posted | Mean | 95% Confidence Interval | cm | Baseline and 12 months |
|
|
|
| Secondary | Change From Baseline in Physical Activity at 12 Months | Posted | Mean | 95% Confidence Interval | MET/min/week | Baseline and 12 months |
|
|
|
| 0 |
| 316 |
| 0 |
| 316 |
| EG001 | Control | Individuals who receive the usual primary health care | 0 | 321 | 0 | 321 |
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| High-fat & sugar food intake (servings/day) |
|