e-Counseling Promotes Blood Pressure Reduction and Therapeutic Lifestyle Change in Hypertension

Hypertension Clinical Trial

— REACH  

Official title:

Reducing Risk With E-based Support for Adherence to Lifestyle Change in Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541540
• Other study ID #: 11-0580-BE
• Status: Completed
• Phase: N/A
• First received: February 17, 2012
• Last updated: October 6, 2016
• Start date: February 2012
• Est. completion date: March 2016

Study information

• Verified date: October 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01792076

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• e-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.
• Control
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.

Locations

Country	Name	City	State
Canada	London Health Science Center	London	Ontario
Canada	Grey Bruce Health Unit	Owen Sound	Ontario
Canada	University Health Network (Toronto Gen Hosp Site)	Toronto	Ontario
Canada	Vancouver Coastal Health	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	Systolic blood pressure, diastolic blood pressure, pulse pressure	12-month	No
Primary	lipoprotein cholesterol	total, low-density, and total/high-density ratio	12-month	No
Primary	10-year absolute risk for Cardiovascular Heart Disease.		12-month	No
Secondary	4-day step count recorded by accelerometry		12-month	No
Secondary	24-hour urinary sodium excretion		12-month	No
Secondary	salivary cotinine	smoke-free living measured by salivary cotinine. Measured only in smokers	12-month	No
Secondary	Fruit and vegetable intake	Diet History Questionnaire	12-month	No