Improved Self Management in Uncontrolled Systolic Hypertension

NCT ID: NCT02032719

Last Updated: 2014-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-06-30

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

Conditions

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Systolic Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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smartphone assisted lifestyle coaching

6 months of smartphone assisted lifestyle coaching

Group Type EXPERIMENTAL

smartphone-assisted health coaching

Intervention Type BEHAVIORAL

smartphone with software provides self monitoring of exercise, diet and stress reduction; provision of timely reminders; photo-journaling of meals; secure text messaging

Lifestyle health coaching

6 months of lifestyle health coaching

Group Type ACTIVE_COMPARATOR

Lifestyle counseling

Intervention Type BEHAVIORAL

Lifestyle counseling

Interventions

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smartphone-assisted health coaching

smartphone with software provides self monitoring of exercise, diet and stress reduction; provision of timely reminders; photo-journaling of meals; secure text messaging

Intervention Type BEHAVIORAL

Lifestyle counseling

Lifestyle counseling

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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York University

OTHER

Sponsor Role lead

Responsible Party

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Paul Ritvo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Southlake Regional Health Centre

Newmarket, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Paul Ritvo, PhD

Role: CONTACT

4165808021

Meysam Pirboglu, MSc

Role: CONTACT

4168325893

Facility Contacts

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Paul Ritvo, PhD

Role: primary

4165808021

Meysam Pirboglu, MSc

Role: backup

4168325893

Other Identifiers

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2012-259

Identifier Type: -

Identifier Source: org_study_id

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