NCT01541540

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

4.1 years

First QC Date

February 17, 2012

Last Update Submit

October 6, 2016

Conditions

Hypertension

Outcome Measures

Primary Outcomes (3)

  • Blood Pressure

    Systolic blood pressure, diastolic blood pressure, pulse pressure

    12-month

  • lipoprotein cholesterol

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

    12-month

  • 10-year absolute risk for Cardiovascular Heart Disease.

    12-month

Secondary Outcomes (4)

  • 4-day step count recorded by accelerometry

    12-month

  • 24-hour urinary sodium excretion

    12-month

  • salivary cotinine

    12-month

  • Fruit and vegetable intake

    12-month

Study Arms (2)

e-Counseling plus Usual Care

EXPERIMENTAL
Behavioral: e-Counseling plus Usual Care

e-Info Control plus Usual Care

ACTIVE COMPARATOR
Behavioral: Control

Interventions

e-Counseling plus Usual CareBEHAVIORAL

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.

e-Counseling plus Usual Care
ControlBEHAVIORAL

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.

e-Info Control plus Usual Care

Eligibility Criteria

Age35 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Vancouver Coastal Health

Vancouver, British Columbia, Canada

Location

London Health Science Center

London, Ontario, Canada

Location

Grey Bruce Health Unit

Owen Sound, Ontario, Canada

Location

University Health Network (Toronto Gen Hosp Site)

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (4)

  • 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.

    PMID: 31669047DERIVED

  • 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.

    PMID: 30006474DERIVED

  • 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.

    PMID: 29752248DERIVED

  • 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.

    PMID: 23965936DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Distance Counseling

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CounselingMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesRemote ConsultationReferral and ConsultationProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care Management

Study Officials

  • Robert P Nolan, Ph.D

    Behavioural Cardiology Research Unit, University Health Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2012

First Posted

March 1, 2012

Study Start

February 1, 2012

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 7, 2016

Record last verified: 2016-10

Locations

CA(4)