REACH- Reducing Risk With E-based Support for Adherence to Lifestyle Change in Hypertension
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Purpose
This randomized controlled trial will evaluate whether preventive e-Counseling (Heart and Stroke Foundation Action Plan, HSF-AP; http://ww2.heartandstroke.ca/hs_bp2.asp?media=bp) improves blood pressure and lifestyle adherence among subjects diagnosed with Stage 1 or 2 hypertension.
Primary hypotheses.
- e-Counseling (vs. Control) will significantly reduce SBP, DBP and pulse pressure (PP) at the 4-, 12-month outcomes, as measured by a validated protocol for automated BP assessment in the clinic23 which we have used in a previous trial.24
- e-Counseling (vs. Control) will significantly reduce CVD risk, as measured by lipoprotein cholesterol (total, low-density, and total/high-density ratio) and the Framingham 10-year absolute CHD risk index.25
Secondary hypotheses:
e-Counseling (vs. Control) will significantly increase adherence to self-management behaviors at the 4- and 12-month outcomes, as measured by objective and validated indices:
- mean 7-day step count recorded by accelerometry
- dietary sodium ≤ 100 mmol/day measured by 24-hour urinary sodium
- smoke-free living measured by salivary cotinine
- fruit and vegetable intake ≥ 9 to12 servings/day, dietary fat < 25% and 2-3 dairy servings/day as measured by an NIH/NCI assessment26 that has been validated for Canadian samples.27.28
- physical activity ≥150 minutes/week as measured by validated assessment29
- Among subjects who are prescribed antihypertensive medications at baseline, e-Counseling (vs. Control) will significantly increase medication adherence as defined by pharmacy refill data and a validated medication compliance index that we have utilized in a previous trial.30 c.) Physical fitness is measured by the 6-minute walk test d.) Autonomic function and baroreceptor sensitivity are measured by ECG and finometer
| Condition | Intervention |
|---|---|
|
Hypertension |
Other: E-counselling Other: e-info and usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | REACH- Reducing Risk With E-based Support for Adherence to Lifestyle Change in Hypertension |
- cholesterol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 24 hour urinary sodium [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 528 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lifestyle counselling
e-Counselling videos and emails
|
Other: E-counselling
E-videos and emails- intervention to assist subjects in lifestyle change to control hypertension
|
|
Placebo Comparator: Control
E-info + usual care (control)
|
Other: e-info and usual care |
Detailed Description:
Individuals with elevated systolic blood pressure (SBP) are at increased risk for cardiovascular disease (CVD; Risk Ratio, RR = 1.47; 95% CI, 1.24-1.74), stroke (RR, 1.42; 95% CI, 1.03-1.93), coronary heart disease (CHD; RR, 1.44; 95% CI, 1.18-1.77), heart failure (HF; RR, 1.60; 95% CI, 1.15-2.22), and CVD mortality (RR, 1.57; 95% CI, 1.24-2.00).1 Hypertension is prevalent among 19 to 21% of Canadian adults 20-79 years of age, and its prevalence rises to 53% among adults 60-79 years of age2, 3, and higher among elderly adults. Hypertension is treated and controlled among only 66% of Canadian adults (SBP < 140, diastolic BP, DBP, < 90 mmHg).2, 3 This is concerning since the risk of cardiovascular mortality among adults 40-69 years of age rises with elevated BP, doubling with each increase of 20 mmHg systolic or 10 mmHg diastolic, from the base index of 115/75 mmHg.
Eligibility| Ages Eligible for Study: | 35 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts 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, heart failure
- Diagnosis of alcohol or drug abuse within past year
- Diagnosis of major psychiatric illness: eg. psychosis, bipolar disorder
- Institutional residence
Contacts and Locations| Contact: Robert P Nolan, PhD | 416-340-4800 ext 6400 | rnolan@uhnres.utoronto.ca |
| Contact: Arooj Khan, BSc | 416-340-4800 ext 4116 | arooj.khan@uhn.on.ca |
| Canada, British Columbia | |
| University of British Columbia | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Martin Dawes, MBBS martin.dawes@ubc.ca | |
| Canada, Ontario | |
| University of Western Ontario | Recruiting |
| London, Ontario, Canada | |
| Contact: Ross Feldman, MBBS ross.feldman@lhsc.ca | |
| Grey Bruce Public Health Unit | Recruiting |
| Owen Sound, Ontario, Canada | |
| Contact: Hazel Lynn, MBBS hazel.lynn@greybrucepublichealth.ca | |
| Principal Investigator: | Robert P Nolan, PhD | University Health Network, Toronto |
More Information
No publications provided
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01792076 History of Changes |
| Other Study ID Numbers: | 0901 |
| Study First Received: | February 12, 2013 |
| Last Updated: | February 13, 2013 |
| Health Authority: | Canada: Research Ethics Board UHN |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013