Improved Self Management in Uncontrolled Systolic Hypertension

January 9, 2014 updated by: Paul Ritvo, York University

Investigating Improved Self Management in Uncontrolled Systolic Hypertension

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Meysam Pirboglu, MSc
  • Phone Number: 4168325893
  • Email: meyir@yorku.ca

Study Locations

  • Canada
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Recruiting
        • Southlake Regional Health Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: smartphone assisted lifestyle coaching
6 months of smartphone assisted lifestyle coaching
Behavioral: 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
ACTIVE_COMPARATOR: Lifestyle health coaching
6 months of lifestyle health coaching
Behavioral: Lifestyle counseling
Lifestyle counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months follow up from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life self report measures
Time Frame: 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
Baseline and 6 months followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

York University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

June 1, 2014

Study Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (ESTIMATE)

January 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-259

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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