Improved Self Management in Uncontrolled Systolic Hypertension

Systolic Hypertension Clinical Trial

Official title:

Investigating Improved Self Management in Uncontrolled Systolic Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02032719
• Other study ID #: 2012-259
• Status: Recruiting
• Phase: Phase 3
• First received: January 6, 2014
• Last updated: January 9, 2014
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2014
• Source: York University
• Contact: Paul Ritvo, PhD
• Phone: 4165808021
• Email: pritvo[@]yorku.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Systolic Hypertension

Intervention

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
• Lifestyle counseling
Lifestyle counseling

Locations

Country	Name	City	State
Canada	Southlake Regional Health Centre	Newmarket	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
York University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Baseline and 6 months followup	No