Hypertension
Conditions
Brief summary
This proposed clinical trial, REACH, will enroll 538 persons with hypertension. All subjects will continue with their prescribed medications. Our main objective is to assess whether preventive e-counseling (provided through a website of the Heart and Stroke Foundation) improves blood pressure and cardiovascular risk status over a 12-month interval. REACH will also evaluate improvement in lifestyle behaviors that include diet, exercise, smoking, and adherence to prescribed medications. Finally, we will quantify the amount of e-counseling support that is required during REACH to evoke a significant reduction in blood pressure. It is hypothesized that e-Counseling (vs. Control) will significantly improve blood pressure and lifestyle behaviours at the 12-month assessment. The findings of this trial will provide information that is critical to our understanding of how internet-based programs can help to improve blood pressure and to reduce the risk for cardiovascular disease.
Interventions
BEHAVIORALe-Counseling plus Usual Care
28 emails will be sent proactively over a 12-month period. Emails will be sent weekly for the first 4 months, biweekly from months 5 to 8, and monthly from months 9 to 12. Each email will contain an e-link to lifestyle counseling activities designed to enhance motivation and skill to initiate and maintain lifestyle change. e-Counseling includes video-based education and counseling as well as e-tools to self-monitor and reinforce adherence to self-management behavior for exercise, diet, prescribed medications and smoke-free living.
BEHAVIORALControl
The control group will receive general educational material on heart healthy living. 28 emails will be sent proactively over a 12-month period. Emails will be sent weekly for the first 4 months, biweekly from months 5 to 8, and monthly from months 9 to 12.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Age: 35-74 years * Diagnosis of hypertension: Medication or physician confirmation * Baseline BP in lab: \>=140/90 (if no meds); \>=130/85 (if on meds) * If medications, prescription unchanged \>=2 months Comprehension of English (oral and written)
Exclusion criteria
* diagnosis of clinically significant arrhythmia, sleep apnea, kidney disease, major psychiatric illness (eg. psychosis), alcohol or drug dependence in the previous year; institutional residence, or an inability to comprehend English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 12-month | Systolic blood pressure, diastolic blood pressure, pulse pressure |
| lipoprotein cholesterol | 12-month | total, low-density, and total/high-density ratio |
| 10-year absolute risk for Cardiovascular Heart Disease. | 12-month | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 4-day step count recorded by accelerometry | 12-month | — |
| Fruit and vegetable intake | 12-month | Diet History Questionnaire |
| 24-hour urinary sodium excretion | 12-month | — |
| salivary cotinine | 12-month | smoke-free living measured by salivary cotinine. Measured only in smokers |
Countries
Canada
Outcome results
None listed