Improved Self Management in Uncontrolled Systolic Hypertension

Phase 3

• Conditions: Systolic Hypertension
• Interventions: Behavioral: smartphone-assisted health coaching; Behavioral: Lifestyle counseling

• Registration Number: NCT02032719
• Lead Sponsor: York University

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 Timeline

• Study Start: 2013-01
• Status Verified: 2014-01
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-09
• Last Update Submitted: 2014-01-09
• Study First Posted: 2014-01-10
• Last Update Posted: 2014-01-10
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
smartphone assisted lifestyle coaching	smartphone-assisted health coaching	6 months of smartphone assisted lifestyle coaching
Lifestyle health coaching	Lifestyle counseling	6 months of lifestyle health coaching

Primary Outcome Measures

Name	Time	Method
24 hour ambulatory blood pressure mean	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 Outcome Measures

Name	Time	Method
Quality of life self report measures	Baseline and 6 months followup	Profile of Mood States - SF Vigor Scale Satisfaction with Life Scale Positive and Negative Affect Schedule Hospital Anxiety and Depression Scale; SF 12

Trial Locations

Locations (1)

Southlake Regional Health Centre; 🇨🇦 Newmarket, Ontario, Canada