Recruiting
Phase 3

Self Management

Sponsor:

York University

Code:

NCT02032719

Conditions

Systolic Hypertension

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Not accepted

Interventions

smartphone-assisted health coaching

Lifestyle counseling

Study Details

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

Conditions

Systolic Hypertension

Study ID

NCT02032719

Start date

Jan, 2013

Status verified date

Jan, 2014

Completion date

Jun, 2014

Anticipated

Primary completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

65 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: smartphone assisted lifestyle coaching

6 months of smartphone assisted lifestyle coaching

active comparator: Lifestyle health coaching

6 months of lifestyle health coaching

Interventions

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

Lifestyle counseling

Lifestyle counseling

Primary outcome measure

  • 24 hour ambulatory blood pressure mean [ Time Frame: 6 months follow up from baseline ]

Central Contacts and Locations

Central contacts

Paul Ritvo, PhD

4165808021pritvo@yorku.ca

Meysam Pirboglu, MSc

4168325893Meyir@yorku.ca

Locations

Southlake Regional Health Centre

Recruiting

Newmarket, Ontario, Canada, L3Y 2P9

Contacts

Paul Ritvo, PhD

4165808021pritvo@yorku.ca

Meysam Pirboglu, MSc

4168325893meyir@yorku.ca

Principal Investigator:

Paul Ritvo, PhD

More Information

Sponsor

York University

Last update posted

Jan 10, 2014

Last verified

Jan, 2014

Keywords

  • Hypertension, Systolic, Uncontrolled

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by York University on 2014-01-10.