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HypertensionREACHNCT01541540

e-Counseling Promotes Blood Pressure Reduction and Therapeutic Lifestyle Change in Hypertension

A study of Hypertension, run by University Health Network, Toronto at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This proposed clinical trial, REACH, will enroll 538 persons with hypertension. All subjects will continue with their prescribed medications. Our main objective is to assess whether preventive e-counseling (provided through a website of the Heart and Stroke Foundation) improves blood pressure and cardiovascular risk… Read more about this study

Who is it for?
Ages 35 to 74 years
Conditions the study is for
Hypertension
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
4 sitesCanada
Study dates
Feb 2012to Mar 2016
Phase
Interventional
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 35 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 35-74 years
  • Diagnosis of hypertension: Medication or physician confirmation
  • Baseline BP in lab: >=140/90 (if no meds); >=130/85 (if on meds)
  • If medications, prescription unchanged >=2 months Comprehension of English (oral and written)

Who cannot join

  • diagnosis of clinically significant arrhythmia, sleep apnea, kidney disease, major psychiatric illness (eg. psychosis), alcohol or drug dependence in the previous year; institutional residence, or an inability to comprehend English

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • London Health Science Center

    London, Ontario

  • Grey Bruce Health Unit

    Owen Sound, Ontario

  • University Health Network (Toronto Gen Hosp Site)

    Toronto, Ontario, M5G 2N2

  • Vancouver Coastal Health

    Vancouver, British Columbia

Other trials in Canada

About this study

Official title: Reducing Risk With E-based Support for Adherence to Lifestyle Change in Hypertension

This proposed clinical trial, REACH, will enroll 538 persons with hypertension. All subjects will continue with their prescribed medications. Our main objective is to assess whether preventive e-counseling (provided through a website of the Heart and Stroke Foundation) improves blood pressure and cardiovascular risk status over a 12-month interval. REACH will also evaluate improvement in lifestyle behaviors that include diet, exercise, smoking, and adherence to prescribed medications. Finally, we will quantify the amount of e-counseling support that is required during REACH to evoke a significant reduction in blood pressure. It is hypothesized that e-Counseling (vs. Control) will significantly improve blood pressure and lifestyle behaviours at the 12-month assessment. The findings of this trial will provide information that is critical to our understanding of how internet-based programs can help to improve blood pressure and to reduce the risk for cardiovascular disease.

Conditions
Hypertension
Being tested
e-Counseling plus Usual Care, Control
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • e-Counseling plus Usual CareBehavioural

    28 emails will be sent proactively over a 12-month period. Emails will be sent weekly for the first 4 months, biweekly from months 5 to 8, and monthly from months 9 to 12. Each email will contain an e-link to lifestyle counseling activities designed to enhance motivation and skill to initiate and maintain lifestyle change. e-Counseling includes video-based education and counseling as well as e-tools to self-monitor and reinforce adherence to self-management behavior for exercise, diet, prescribed medications and smoke-free living.

  • ControlBehavioural

    The control group will receive general educational material on heart healthy living. 28 emails will be sent proactively over a 12-month period. Emails will be sent weekly for the first 4 months, biweekly from months 5 to 8, and monthly from months 9 to 12.

Study groups in NCT01541540
Study groupRoleWhat they receive
e-Counseling plus Usual CareExperimentalNot described
Receives: Behavioral: e-Counseling plus Usual Care
e-Info Control plus Usual CareActive comparatorNot described
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Pressure

    Systolic blood pressure, diastolic blood pressure, pulse pressure

    Measured: 12-month

  2. lipoprotein cholesterol

    total, low-density, and total/high-density ratio

    Measured: 12-month

  3. 10-year absolute risk for Cardiovascular Heart Disease.

    Measured: 12-month

Secondary outcomes (4)

  1. 4-day step count recorded by accelerometry

    Measured: 12-month

  2. 24-hour urinary sodium excretion

    Measured: 12-month

  3. salivary cotinine

    smoke-free living measured by salivary cotinine. Measured only in smokers

    Measured: 12-month

  4. Fruit and vegetable intake

    Diet History Questionnaire

    Measured: 12-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

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 N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01541540
Sponsor's protocol ID
11-0580-BE
Acronym
REACH
Status last verified
Oct 2016
First submitted
17 Feb 2012
Last updated
7 Oct 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Liu S, Tanaka R, Barr S, Nolan RP. Effects of self-guided e-counseling on health behaviors and blood pressure: Results of a randomized trial. Patient Educ Couns. 2020 Mar;103(3):635-641. doi: 10.1016/j.pec.2019.10.007. Epub 2019 Oct 19.

    PubMed 31669047

  • Nolan RP, Feldman R, Dawes M, Kaczorowski J, Lynn H, Barr SI, MacPhail C, Thomas S, Goodman J, Eysenbach G, Liu S, Tanaka R, Surikova J. Randomized Controlled Trial of E-Counseling for Hypertension: REACH. Circ Cardiovasc Qual Outcomes. 2018 Jul;11(7):e004420. doi: 10.1161/CIRCOUTCOMES.117.004420.

    PubMed 30006474

  • Tanaka R, Nolan RP. Psychobehavioral Profiles to Assist Tailoring of Interventions for Patients With Hypertension: Latent Profile Analysis. J Med Internet Res. 2018 May 11;20(5):e149. doi: 10.2196/jmir.8757.

    PubMed 29752248

  • Nolan RP, Liu S, Feldman R, Dawes M, Barr S, Lynn H, Gwardy-Sridhar F, Thomas SG, Goodman J, Oh P, Kaczorowski J, Chessex C, Hachinski V, Shoemaker K. Reducing risk with e-based support for adherence to lifestyle change in hypertension (REACH): protocol for a multicentred randomised controlled trial. BMJ Open. 2013 Aug 21;3(8):e003547. doi: 10.1136/bmjopen-2013-003547.

    PubMed 23965936

Questions about this trial

What is this clinical trial studying?

A study of Hypertension, run by University Health Network, Toronto at 4 sites 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure (time frame: 12-month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01541540, which also lists 4 linked publications.

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 7 Oct 2016.

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