CClinicalTrials.gg
Status unknownNCT02032719Updated Jan 10, 2014

Improved Self Management in Uncontrolled Systolic Hypertension

A Phase 3 interventional study of smartphone-assisted health coaching and Lifestyle counseling in Systolic Hypertension, sponsored by York University. Status unknown at 1 site in Canada. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-01-10.

Sponsored by York University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
25 Years to 70 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Systolic Hypertension

Keywords

  • Hypertension, Systolic, Uncontrolled
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 65 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

York University is the lead sponsor of 51 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 25 - 70 years old;
  • mean daytime systolic BP> 130 mm. Hg.

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
65 participants (estimated)

Study arms

  • Experimental
    smartphone assisted lifestyle coaching

    6 months of smartphone assisted lifestyle coaching

    Behavioral: smartphone-assisted health coaching

  • Active comparator
    Lifestyle health coaching

    6 months of lifestyle health coaching

    Behavioral: Lifestyle counseling

Interventions

  • Behavioralsmartphone-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

  • BehavioralLifestyle counseling

    Lifestyle counseling

06

What researchers measure

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

    Time frame: 6 months follow up from baseline

Secondary outcomes

  1. 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

    Time frame: Baseline and 6 months followup

07

Study locations

1 of 1 sites recruiting
  • Southlake Regional Health Centre
    Newmarket, Ontario L3Y 2P9, Canada
    • Paul Ritvo, PhD · Contact · pritvo@yorku.ca · 4165808021
    • Meysam Pirboglu, MSc · Contact · meyir@yorku.ca · 4168325893
    • Paul Ritvo, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02032719
Lead sponsor
York University
Responsible party
Paul Ritvo (Principal Investigator, York University) — Principal investigator
First posted
Jan 10, 2014
Start date
Jan 2013
Primary completion
Jun 2014 (estimated)
Completion
Jun 2014 (estimated)
Last update
Jan 10, 2014

Study contacts

Paul Ritvo, PhD
Contact
pritvo@yorku.ca
4165808021
Meysam Pirboglu, MSc
Contact
Meyir@yorku.ca
4168325893

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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