NCT03111836

Effectiveness of User and Expert Driven Internet-based Lifestyle Interventions on Hypertension Control

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: University of Toronto · Academic / Other
• Sex: All
• Age: 35 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

Hypertension is a leading risk factor for cardiovascular disease and mortality. Lifestyle counseling is recommended as a first line therapy for reducing blood pressure (BP) and risk for cardiovascular events. Recent studies suggest that e-based lifestyle interventions are effective in evoking therapeutic change in BP1. However, BP response and adherence to exercise and diet behavior varies significantly after e-based interventions due to variations in treatment methodologies. Consensus is not yet established for a standardized e-counseling protocol for hypertension. As noted in our systematic review, the two dominant models of e-counseling procedures are expert-driven (protocol driven, prescriptive) and user-driven (self-guided, collaborative). Expert-driven programs prescribe specific changes for lifestyle behavior which are intended to facilitate compliance to behavioral change. In contrast, the user-driven method actively involves the subject in goal-setting and/or the selection of the intervention used to reach the behavioral goal. One conclusion from the systematic review is that these models are used indiscriminately in e-counseling programs. There is currently inadequate data to determine the efficacy of programs that are expert-driven vs. user-driven in reducing BP while modifying lifestyle behaviour. It is possible that a combination of expert-driven and user-driven features for lifestyle e-counseling is most effective. However, before these two approaches can be combined, it is essential to establish the strengths and limitations of each model.

Detailed description

This study will use a 3-parallel group, randomized controlled design: 3 (Groups: Control, expert-driven, and user-driven e-Counselling) by 2 (Assessments: baseline, 4-month). Controls will receive general e-information on BP management. The expert-driven e-Counselling group will provide a prescribed exercise and a diet plan. The user-driven e-Counselling group will a program that enables the patient to choose areas of focus. All subjects will be sent 16 e-messages on a weekly schedule.

Conditions

• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	Control Group	Received general information about blood pressure control. All subjects will be sent 16 e-messages on a weekly schedule.
BEHAVIORAL	Expert-Driven Group	The user-driven e-Counselling group will receive a lifestyle program where the user are able to choose areas of focus. All subjects will be sent 16 e-messages on a weekly schedule.
BEHAVIORAL	User-driven group	The user-driven e-Counselling group will receive a lifestyle program where the user are able to choose areas of focus. All subjects will be sent 16 e-messages on a weekly schedule.

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-07-01
• Completion: 2015-06-01
• First posted: 2017-04-13
• Last updated: 2017-04-13