Improved Self Management in Uncontrolled Systolic Hypertension

York University

Status and phase: Unknown; Phase 3

Conditions: Systolic Hypertension

Treatments: Behavioral: smartphone-assisted health coaching; Behavioral: Lifestyle counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT02032719

2012-259

Details and patient eligibility

About

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

Full 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

Enrollment: 65 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

smartphone assisted lifestyle coaching

Experimental group

Description:

6 months of smartphone assisted lifestyle coaching

Treatment:

Behavioral: smartphone-assisted health coaching

Lifestyle health coaching

Active Comparator group

Description:

6 months of lifestyle health coaching

Treatment:

Behavioral: Lifestyle counseling