Improved Self Management in Uncontrolled Systolic Hypertension

Study Overview
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Brief Summary
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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
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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

Official Title
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Investigating Improved Self Management in Uncontrolled Systolic Hypertension

Conditions
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Systolic Hypertension

Intervention / Treatment
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* Behavioral: smartphone-assisted health coaching
* Behavioral: Lifestyle counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: smartphone assisted lifestyle coaching<br>6 months of smartphone assisted lifestyle coaching | Behavioral: smartphone-assisted health coaching<br>* smartphone with software provides self monitoring of exercise, diet and stress reduction; provision of timely reminders; photo-journaling of meals; secure text messaging<br>|
| Active Comparator: Lifestyle health coaching<br>6 months of lifestyle health coaching | Behavioral: Lifestyle counseling<br>* Lifestyle counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour ambulatory blood pressure mean | 24 hour ambulatory blood pressure assessed at baseline and 6 months follow up in experimental and control groups | 6 months follow up from baseline | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Systolic, Uncontrolled