Effectiveness of an E-health Educational Intervention for Cardiovascular Disease Adults in Improving Outcomes

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350192
• Other study ID #: 10110301
• Status: Completed
• Phase: N/A
• First received: January 21, 2015
• Last updated: July 26, 2016
• Start date: June 2013
• Est. completion date: July 2015

Study information

• Verified date: July 2016
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• e-health educational intervention (eHEI)
The e-HEI link (e-health link http://ehealth.nur.cuhk.edu.hk) provides the content of culture-specific cognitive knowledge related to CVD and measures to modify risk factors. The member area and interactive platform of the e-HEI website allows the self-monitoring of individual health and exercise records. Members can view and retrieve their own exercise records daily, and health measures trend regularly.

Locations

Country	Name	City	State
Hong Kong	Tung Wah Eastern Hospital	Causeway Bay	Hong Kong Island
Hong Kong	Pamela Youde Nethersole Eastern Hospital	Chai Wan	Hong Kong Island

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in total physical exercise (measured by The Godin-Shephard Leisure-Time Physical Activity Questionnaire)	Change in physical exercise is	Baseline, 3 Months, 6 Months	No
Secondary	Changes in exercise efficacy (measured by a validated scale. The scale consists of 9 items and responses are made on a 0-10 scale)	Changes in self-efficacy for exercise is measured by a validated scale. The scale consists of 9 items and responses are made on a 0-10 scale.	Baseline, 3 Months, 6 Months	No
Secondary	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?)	To 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?	Baseline, 3 Months, 6 Months	No
Secondary	Changes in anxiety and depression (Chinese version of the Hospital anxiety and depression scale)	The Chinese version of the Hospital anxiety and depression scale will be used to measure the changes in anxiety and depression. The scale consists of 14 items and responses on a 4 point likert scale.	Baseline, 3 Months, 6 Months	No
Secondary	Changes in quality of Life (Chinese version of the health survey questionnaire (SF-12)	Chinese version of the health survey questionnaire (SF-12) will be used in measuring the changes in quality of life.	Baseline, 3 Months, 6 Months	No
Secondary	Cardiac risk factor profile (Demographic data will be collected through questionnaire)	Demographic data will be collected through questionnaire. Medical problems, cardiac risk profile such as (systolic and diastolic blood pressure, LDL cholesterol, HDL cholesterol, triglycerides, blood sugar level, HbA1c, BMI will be retrieved from the patients' medical records.	Baseline, 3 Months, 6 Months	No