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Improved Self Management in Uncontrolled Systolic Hypertension

Y

York University

Status and phase

Unknown
Phase 3

Conditions

Systolic Hypertension

Treatments

Behavioral: smartphone-assisted health coaching
Behavioral: Lifestyle counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT02032719
2012-259

Details and patient eligibility

About

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

Full 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

Enrollment

65 estimated patients

Sex

All

Ages

25 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

65 participants in 2 patient groups

smartphone assisted lifestyle coaching
Experimental group
Description:
6 months of smartphone assisted lifestyle coaching
Treatment:
Behavioral: smartphone-assisted health coaching
Lifestyle health coaching
Active Comparator group
Description:
6 months of lifestyle health coaching
Treatment:
Behavioral: Lifestyle counseling

Trial contacts and locations

1

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Central trial contact

Paul Ritvo, PhD; Meysam Pirboglu, MSc

Data sourced from clinicaltrials.gov

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