Improved Self Management in Uncontrolled Systolic Hypertension
Investigating Improved Self Management in Uncontrolled Systolic Hypertension
1 other identifier
interventional
65
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 6, 2014
CompletedFirst Posted
Study publicly available on registry
January 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJanuary 10, 2014
January 1, 2014
1.4 years
January 6, 2014
January 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Quality of life self report measures
Baseline and 6 months followup
Study Arms (2)
smartphone assisted lifestyle coaching
EXPERIMENTAL6 months of smartphone assisted lifestyle coaching
Lifestyle health coaching
ACTIVE COMPARATOR6 months of lifestyle health coaching
Interventions
smartphone with software provides self monitoring of exercise, diet and stress reduction; provision of timely reminders; photo-journaling of meals; secure text messaging
Eligibility Criteria
You may qualify if:
- years old;
- mean daytime systolic BP\> 130 mm. Hg.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- York Universitylead
Study Sites (1)
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 6, 2014
First Posted
January 10, 2014
Study Start
January 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
January 10, 2014
Record last verified: 2014-01