Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improved Self Management in Uncontrolled Systolic Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02032719
Recruitment Status : Unknown
Verified January 2014 by Paul Ritvo, York University.
Recruitment status was:  Recruiting
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Paul Ritvo, 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

Condition or disease Intervention/treatment Phase
Systolic Hypertension Behavioral: smartphone-assisted health coaching Behavioral: Lifestyle counseling Phase 3

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating Improved Self Management in Uncontrolled Systolic Hypertension
Study Start Date : January 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032719


Contacts
Layout table for location contacts
Contact: Paul Ritvo, PhD 4165808021 pritvo@yorku.ca
Contact: Meysam Pirboglu, MSc 4168325893 Meyir@yorku.ca

Locations
Layout table for location information
Canada, Ontario
Southlake Regional Health Centre Recruiting
Newmarket, Ontario, Canada, L3Y 2P9
Contact: Paul Ritvo, PhD    4165808021    pritvo@yorku.ca   
Contact: Meysam Pirboglu, MSc    4168325893    meyir@yorku.ca   
Principal Investigator: Paul Ritvo, PhD         
Sponsors and Collaborators
York University

Layout table for additonal information
Responsible Party: Paul Ritvo, Principal Investigator, York University
ClinicalTrials.gov Identifier: NCT02032719     History of Changes
Other Study ID Numbers: 2012-259
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by Paul Ritvo, York University:
Hypertension, Systolic, Uncontrolled
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases