Systolic HypertensionPhase 3NCT02032719
Improved Self Management in Uncontrolled Systolic Hypertension
A Phase 3 study testing smartphone-assisted health coaching and Lifestyle counseling in people with Systolic Hypertension, run by York University at 1 site in Canada.
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 Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Systolic Hypertension
- What is being tested?
- smartphone-assisted health coaching and Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Jun 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25 - 70 years old;
- mean daytime systolic BP> 130 mm. Hg.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Paul Ritvo, PhD, 4165808021, pritvo@yorku.ca
Meysam Pirboglu, MSc, 4168325893, meyir@yorku.ca
About this study
Official title: Investigating Improved Self Management in Uncontrolled Systolic Hypertension
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
- Conditions
- Systolic Hypertension
- Being tested
- smartphone-assisted health coaching, Lifestyle counseling
- Keywords
- Hypertension, Systolic, Uncontrolled
- Medical subject headings
- Isolated Systolic Hypertension, Hypertension, Systolic Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smartphone-assisted health coachingBehavioural
smartphone with software provides self monitoring of exercise, diet and stress reduction; provision of timely reminders; photo-journaling of meals; secure text messaging
Lifestyle counselingBehavioural
Lifestyle counseling
| Study group | Role | What they receive |
|---|---|---|
| smartphone assisted lifestyle coaching | Experimental | 6 months of smartphone assisted lifestyle coaching Receives: Behavioral: smartphone-assisted health coaching |
| Lifestyle health coaching | Active comparator | 6 months of lifestyle health coaching Receives: Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour ambulatory blood pressure mean
24 hour ambulatory blood pressure assessed at baseline and 6 months follow up in experimental and control groups
Measured: 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
Measured: Baseline and 6 months followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systolic HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Ritvo, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032719
- Sponsor's protocol ID
- 2012-259
- Status last verified
- Jan 2014
- First submitted
- 6 Jan 2014
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Improved Self Management in Uncontrolled Systolic Hypertension
- ClinicalTrials.gov ID
- NCT02032719
- Acronym / sponsor ID
- 2012-259
- Conditions
- Systolic Hypertension
- Keywords
- Hypertension, Systolic, Uncontrolled
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smartphone assisted lifestyle coaching | Experimental | Behavioral: smartphone-assisted health coaching6 months of smartphone assisted lifestyle coaching |
| Lifestyle health coaching | Active comparator | Behavioral: Lifestyle counseling6 months of lifestyle health coaching |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 25 - 70 years old;
- mean daytime systolic BP> 130 mm. Hg.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smartphone-assisted health coachingsmartphone with software provides self monitoring of exercise, diet and stress reduction; provision of timely reminders; photo-journaling of meals; secure text messaging | Behavioural | smartphone assisted lifestyle coaching |
| Lifestyle counselingLifestyle counseling | Behavioural | Lifestyle health coaching |
Primary outcome
24 hour ambulatory blood pressure mean
Time frame: 6 months follow up from baseline
24 hour ambulatory blood pressure assessed at baseline and 6 months follow up in experimental and control groups
1 secondary outcome
Quality of life self report measures
Time frame: Baseline and 6 months followup
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
Related trials for Systolic Hypertension
RecruitingPhase 2
A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
Uncontrolled Hypertension
Recruiting
Air Pollution and Cardiovascular Disease in Qatar: an Interventional Study to Reduce Blood Pressure
Hypertension, Systolic, Metabolic Syndrome
Recruiting
Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure
Hypertension, Atherosclerotic Cardiovascular Disease
Recruiting
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Hypertension, Hypertension, Systolic
Active, not recruitingPhase 2
Nicotinamide Riboside for Treating Elevated Systolic Blood Pressure and Arterial Stiffness in Middle-aged and Older Adults
Hypertension, Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing smartphone-assisted health coaching and Lifestyle counseling in people with Systolic Hypertension, run by York University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Ritvo, PhD (4165808021, pritvo@yorku.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour ambulatory blood pressure mean (time frame: 6 months follow up from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.