Improved Self Management in Uncontrolled Systolic Hypertension

Investigating Improved Self Management in Uncontrolled Systolic Hypertension

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02032719

Enrollment

Registered

2014-01-10

Start date

2013-01-31

Completion date

2014-06-30

Last updated

2014-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systolic Hypertension

Keywords

Hypertension, Systolic, Uncontrolled

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
24 hour ambulatory blood pressure mean	6 months follow up from baseline	24 hour ambulatory blood pressure assessed at baseline and 6 months follow up in experimental and control groups

Secondary

Measure	Time frame	Description
Quality of life self report measures	Baseline and 6 months followup	Profile of Mood States - SF Vigor Scale Satisfaction with Life Scale Positive and Negative Affect Schedule Hospital Anxiety and Depression Scale; SF 12

Countries

Canada

Contacts

Primary ContactPaul Ritvo, PhD

pritvo@yorku.ca4165808021

Backup ContactMeysam Pirboglu, MSc

Meyir@yorku.ca4168325893

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026