Clinical trial NCT02350192: Effectiveness of an E-health Educational Intervention for Cardiovascular Disease Adults in Improving Outcomes
Official title: A Randomized Controlled Trial of the Effectiveness of a Home-based Interactive E-health Educational Intervention for Middle-aged Cardiovascular Disease Adults in Improving Total Exercise, Adherence Rate, Exercise Efficacy and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: ehealth
intervention
effectiveness
randomized controlled trial
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 438
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cardiovascular disease (CVD) is the leading cause of death globally and e-health educational programs have been proved to be effective support to CVD clients. However, most e-health programs lack personalization and this seldom results in exercise behavioral change. Considering the advantages of e-health programs, as well as the widespread internet use and the rising trend of younger patients having CVD in Hong Kong, we conducted a Randomized Controlled Trial (RCT) to investigate the effectiveness of a home-based interactive e-health educational intervention versus usual care for middle aged cardiac vascular (CV) patients on their total physical exercise, exercise adherence and quality of life.

Detailed description: Introduction:

Cardiovascular disease (CVD) is the leading cause of death globally and e-health educational programs have been proved to be effective support to CVD clients. However, most e-health programs lack personalization and this seldom results in exercise behavioral change. Considering the advantages of e-health programs, as well as the widespread internet use and the rising trend of younger patients having CVD in Hong Kong, we conducted a Randomized Controlled Trial (RCT) to investigate the effectiveness of a home-based interactive e-health educational intervention versus usual care on total physical exercise, exercise adherence and self efficacy, risk factor profile, psychological outcomes and quality of life for middle aged cardiac vascular (CV) patients.

Methods and analysis:

This is a prospective randomised clinical trial investigating effectiveness of a home-based interactive e-health educational intervention for middle-aged cardiovascular disease (CVD) adults in improving total exercise, adherence rate, exercise efficacy and outcomes. The hypothesis is that the middle-aged CVD patients (those who are 40-65 years old) would be more likely to adhere to exercise-based behavior that improves their total exercise, exercise adherence rate, cardiac risk profile , psychological outcomes and quality of life with the support of an interactive e-health educational intervention.

The RCT was conducted in two government cardiac clinics in Hong Kong. 438 eligible CV clients were randomized to either the control group (C) or the intervention group (I) using block randomization method. All participants received usual care while (I) additionally received the e-health educational intervention (eHEI) programme. This programme comprised of one-hour educational session, one telephone follow up and e-health link on self monitoring including record of health measures and physical exercise across 6 months. Data was collected at baseline, three months and six months intervals. The primary outcome was total physical exercise (GSLTPAQ). Secondary outcomes consisted of: exercise efficacy and adherence rate; CV risk profile; physical and psychological health outcomes (SF12 \& HAD); biological parameter. Data was analyzed using generalized linear models.

Ethics and dissemination: The study complies with the Declaration of Helsinki and was approved by the University and hospital ethics committee. Study findings will be disseminated in international conferences and publications.

Key messages:

Cardiovascular disease (CVD) is the leading cause of death globally and most e-health educational programs have been proved to be effective support to CVD clients. However, most e-health programs lack personalization and this seldom results in exercise behavioral change.

The adopted e-health program aims to empower CVD participants by increase knowledge on cardiovascular risks, perceived benefits of exercise to health, as well as enhance their self-efficacy in exercise adherence and exercise behavior. Data analysis has been started in August 2015. This trial will provide evidence of e-health programs on physical and psychological outcomes comprehensively.

Strengths and limitations of this study:

The study has been designed to meet the criteria for high quality in non-pharmacological randomised clinical trials with randomisation, multicentre participation, blinded assessment and analysis with good sample size.

Eligibility criteria: Inclusion Criteria:

* being an ethnic Chinese adult
* who attends regular follow-up treatments for their CVD problems
* aged 30-65
* able to use and access the internet at home
* willing to participate (with corresponding signed consent form)

Exclusion Criteria:

* those with physical, mental, visual, or cognitive impairments as recorded in their health records
* those who have contra-indications to walking.

Primary outcomes:
measure: Changes in total physical exercise (measured by The Godin-Shephard Leisure-Time Physical Activity Questionnaire)
timeFrame: Baseline, 3 Months, 6 Months
Secondary outcomes:
measure: Changes in exercise efficacy (measured by a validated scale. The scale consists of 9 items and responses are made on a 0-10 scale)
timeFrame: Baseline, 3 Months, 6 Months
measure: Exercise adherence (two simple questions will be asked: how often do you do any physical activity per week? and What is the duration of the exercise on average?)
timeFrame: Baseline, 3 Months, 6 Months
measure: Changes in anxiety and depression (Chinese version of the Hospital anxiety and depression scale)
timeFrame: Baseline, 3 Months, 6 Months
measure: Changes in quality of Life (Chinese version of the health survey questionnaire (SF-12)
timeFrame: Baseline, 3 Months, 6 Months
measure: Cardiac risk factor profile (Demographic data will be collected through questionnaire)
timeFrame: Baseline, 3 Months, 6 Months
Other outcomes:
Locations:
city: Causeway Bay
country: Hong Kong
facility: Tung Wah Eastern Hospital
state: Hong Kong Island
city: Chai Wan
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
state: Hong Kong Island
Study officials:
affiliation: Chinese University of Hong Kong
name: Eliza Mi Ling Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: