NCT02350192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
438

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

2.1 years

First QC Date

January 21, 2015

Last Update Submit

July 26, 2016

Conditions

Keywords

ehealthinterventioneffectivenessrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Changes in exercise efficacy (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

  • 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

  • Changes in anxiety and depression (Chinese version of the Hospital anxiety and depression scale)

    Baseline, 3 Months, 6 Months

  • Changes in quality of Life (Chinese version of the health survey questionnaire (SF-12)

    Baseline, 3 Months, 6 Months

  • Cardiac risk factor profile (Demographic data will be collected through questionnaire)

    Baseline, 3 Months, 6 Months

Study Arms (2)

e-health educational intervention (eHEI)

EXPERIMENTAL

Participants in the intervention group received usual care and additional individualized educational intervention administered by a trained nurse who was experienced in cardiac nursing. The exercise prescription had been set as walking exercise for 30 minutes per day for 5 days per week. The exercise dosage might be modified with physician's order to suit the individual's physical condition and agreed goals if necessary. The 30- minutes educational intervention was conducted in a private room of the clinic. The content covered general information related to coronary heart disease and benefit of performing exercise, the e-health educational intervention (eHEI) link demonstration and re-demonstration. In addition, one telephone follow-up was conducted at week 2 to facilitate the usage of the e-HEI link.

Behavioral: e-health educational intervention (eHEI)

Control group

NO INTERVENTION

Control group received standard care only. The control group also received standard usual care comprising the doctor follow up with medication. During an individualized educational session conducted by a trained research assistant , a briefing on healthy life style and an an additional educational leaflet about coronary heart disease which is customarily given to patient with cardiovascular risks was given to the patient. In the control group, no e-health educational intervention has been provided to the patients of the control group.

Interventions

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.

e-health educational intervention (eHEI)

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tung Wah Eastern Hospital

Causeway Bay, Hong Kong Island, Hong Kong

Location

Pamela Youde Nethersole Eastern Hospital

Chai Wan, Hong Kong Island, Hong Kong

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Eliza Mi Ling Wong, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 21, 2015

First Posted

January 29, 2015

Study Start

June 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 27, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations