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

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
e-Counseling plus Usual Care
Control
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension

Eligibility Criteria

35 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Vancouver Coastal Health
  • London Health Science Center
  • Grey Bruce Health Unit
  • University Health Network (Toronto Gen Hosp Site)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

e-Counseling plus Usual Care

e-Info Control plus Usual Care

Arm Description

Outcomes

Primary Outcome Measures

Blood Pressure
Systolic blood pressure, diastolic blood pressure, pulse pressure
lipoprotein cholesterol
total, low-density, and total/high-density ratio
10-year absolute risk for Cardiovascular Heart Disease.

Secondary Outcome Measures

4-day step count recorded by accelerometry
24-hour urinary sodium excretion
salivary cotinine
smoke-free living measured by salivary cotinine. Measured only in smokers
Fruit and vegetable intake
Diet History Questionnaire

Full Information

First Posted
February 17, 2012
Last Updated
October 6, 2016
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01541540
Brief Title
e-Counseling Promotes Blood Pressure Reduction and Therapeutic Lifestyle Change in Hypertension
Acronym
REACH
Official Title
Reducing Risk With E-based Support for Adherence to Lifestyle Change in Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
e-Counseling plus Usual Care
Arm Type
Experimental
Arm Title
e-Info Control plus Usual Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
e-Counseling plus Usual Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood Pressure
Description
Systolic blood pressure, diastolic blood pressure, pulse pressure
Time Frame
12-month
Title
lipoprotein cholesterol
Description
total, low-density, and total/high-density ratio
Time Frame
12-month
Title
10-year absolute risk for Cardiovascular Heart Disease.
Time Frame
12-month
Secondary Outcome Measure Information:
Title
4-day step count recorded by accelerometry
Time Frame
12-month
Title
24-hour urinary sodium excretion
Time Frame
12-month
Title
salivary cotinine
Description
smoke-free living measured by salivary cotinine. Measured only in smokers
Time Frame
12-month
Title
Fruit and vegetable intake
Description
Diet History Questionnaire
Time Frame
12-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Nolan, Ph.D
Organizational Affiliation
Behavioural Cardiology Research Unit, University Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver Coastal Health
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
London Health Science Center
City
London
State/Province
Ontario
Country
Canada
Facility Name
Grey Bruce Health Unit
City
Owen Sound
State/Province
Ontario
Country
Canada
Facility Name
University Health Network (Toronto Gen Hosp Site)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
31669047
Citation
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.
Results Reference
derived
PubMed Identifier
30006474
Citation
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.
Results Reference
derived
PubMed Identifier
29752248
Citation
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.
Results Reference
derived
PubMed Identifier
23965936
Citation
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.
Results Reference
derived

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

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