Back to resultsImproved Self Management in Uncontrolled Systolic Hypertension
Primary Purpose
Systolic Hypertension
Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
smartphone-assisted health coaching
Lifestyle counseling
Sponsored by
About this trial
This is an interventional treatment trial for Systolic Hypertension focused on measuring Hypertension, Systolic, Uncontrolled
Eligibility 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.
Sites / Locations
- Southlake Regional Health CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
smartphone assisted lifestyle coaching
Lifestyle health coaching
Arm Description
6 months of smartphone assisted lifestyle coaching
6 months of lifestyle health coaching
Outcomes
Primary Outcome Measures
24 hour ambulatory blood pressure mean
24 hour ambulatory blood pressure assessed at baseline and 6 months follow up in experimental and control groups
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02032719
Brief Title
Improved Self Management in Uncontrolled Systolic Hypertension
Official Title
Investigating Improved Self Management in Uncontrolled Systolic Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
York University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systolic Hypertension
Keywords
Hypertension, Systolic, Uncontrolled
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
smartphone assisted lifestyle coaching
Arm Type
Experimental
Arm Description
6 months of smartphone assisted lifestyle coaching
Arm Title
Lifestyle health coaching
Arm Type
Active Comparator
Arm Description
6 months of lifestyle health coaching
Intervention Type
Behavioral
Intervention Name(s)
smartphone-assisted health coaching
Intervention Description
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
Intervention Name(s)
Lifestyle counseling
Intervention Description
Lifestyle counseling
Primary Outcome Measure Information:
Title
24 hour ambulatory blood pressure mean
Description
24 hour ambulatory blood pressure assessed at baseline and 6 months follow up in experimental and control groups
Time Frame
6 months follow up from baseline
Secondary Outcome Measure Information:
Title
Quality of life self report measures
Description
Profile of Mood States - SF Vigor Scale Satisfaction with Life Scale Positive and Negative Affect Schedule Hospital Anxiety and Depression Scale; SF 12
Time Frame
Baseline and 6 months followup
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Ritvo, PhD
Phone
4165808021
Email
pritvo@yorku.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Meysam Pirboglu, MSc
Phone
4168325893
Email
Meyir@yorku.ca
Facility Information:
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Ritvo, PhD
Phone
4165808021
Email
pritvo@yorku.ca
First Name & Middle Initial & Last Name & Degree
Meysam Pirboglu, MSc
Phone
4168325893
Email
meyir@yorku.ca
First Name & Middle Initial & Last Name & Degree
Paul Ritvo, PhD
12. IPD Sharing Statement
Learn more about this trial
Improved Self Management in Uncontrolled Systolic Hypertension
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