Clinical trial NCT01541540: e-Counseling Promotes Blood Pressure Reduction and Therapeutic Lifestyle Change in Hypertension
Official title: Reducing Risk With E-based Support for Adherence to Lifestyle Change in Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-03-01
Enrollment: 264
Sex: ALL
Minimum age (years): 35
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Blood Pressure
timeFrame: 12-month
measure: lipoprotein cholesterol
timeFrame: 12-month
measure: 10-year absolute risk for Cardiovascular Heart Disease.
timeFrame: 12-month
Secondary outcomes:
measure: 4-day step count recorded by accelerometry
timeFrame: 12-month
measure: 24-hour urinary sodium excretion
timeFrame: 12-month
measure: salivary cotinine
timeFrame: 12-month
measure: Fruit and vegetable intake
timeFrame: 12-month
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Coastal Health
state: British Columbia
city: London
country: Canada
facility: London Health Science Center
state: Ontario
city: Owen Sound
country: Canada
facility: Grey Bruce Health Unit
state: Ontario
city: Toronto
country: Canada
facility: University Health Network (Toronto Gen Hosp Site)
state: Ontario
Study officials:
affiliation: Behavioural Cardiology Research Unit, University Health Network
name: Robert P Nolan, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.