Investigating Improved Self Management in Uncontrolled Systolic Hypertension
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- York University
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- 24 hour ambulatory blood pressure mean
Study Overview
Brief Summary
Patients who receive smartphone-assisted health coaching will have a significantly lower 24 hour ambulatory blood pressure mean than patients who receive just health coaching
Detailed Description
Primary Outcome Measure: Mean 24 hour ambulatory blood pressure
Secondary Outcome Measures: Profile of Mood States-SF Vigor Scale; Satisfaction with Life Scale; Positive and Negative Affect Schedule; Hospital Anxiety and Depression Scale; SF - 12
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •25 - 70 years old;
- •mean daytime systolic BP> 130 mm. Hg.
Exclusion Criteria
- •Severe or end-stage organ disease (liver, kidney, heart, lung) or history of diabetic ketoacidosis, or any other illness with expected survival less than 1 year;
- •severe cognitive impairment;
- •diagnosed psychiatric illness or disability;
- •clinical significant cardiac arrhythmia;
- •symptomatic orthostatic hypertension;
- •pregnancy;
- •not fluent in english.
Arms & Interventions
smartphone assisted lifestyle coaching
6 months of smartphone assisted lifestyle coaching
Intervention: smartphone-assisted health coaching (Behavioral)
Lifestyle health coaching
6 months of lifestyle health coaching
Intervention: Lifestyle counseling (Behavioral)
Outcomes
Primary Outcomes
24 hour ambulatory blood pressure mean
Time Frame: 6 months follow up from baseline
24 hour ambulatory blood pressure assessed at baseline and 6 months follow up in experimental and control groups
Secondary Outcomes
- Quality of life self report measures(Baseline and 6 months followup)
Investigators
Paul Ritvo
Principal Investigator
York University