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

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ClinicalTrials.gov Identifier: NCT02350192
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Wong Mi Ling Eliza, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Behavioral: e-health educational intervention (eHEI) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
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 Start Date : June 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: e-health educational intervention (eHEI)
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)
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.

No Intervention: Control group
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.



Primary Outcome Measures :
  1. Changes in total physical exercise (measured by The Godin-Shephard Leisure-Time Physical Activity Questionnaire) [ Time Frame: Baseline, 3 Months, 6 Months ]
    Change in physical exercise is


Secondary Outcome Measures :
  1. Changes in exercise efficacy (measured by a validated scale. The scale consists of 9 items and responses are made on a 0-10 scale) [ Time Frame: Baseline, 3 Months, 6 Months ]
    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.

  2. 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?) [ Time Frame: Baseline, 3 Months, 6 Months ]
    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?

  3. Changes in anxiety and depression (Chinese version of the Hospital anxiety and depression scale) [ Time Frame: Baseline, 3 Months, 6 Months ]
    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.

  4. Changes in quality of Life (Chinese version of the health survey questionnaire (SF-12) [ Time Frame: Baseline, 3 Months, 6 Months ]
    Chinese version of the health survey questionnaire (SF-12) will be used in measuring the changes in quality of life.

  5. Cardiac risk factor profile (Demographic data will be collected through questionnaire) [ Time Frame: Baseline, 3 Months, 6 Months ]
    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.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350192


Locations
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Hong Kong
Tung Wah Eastern Hospital
Causeway Bay, Hong Kong Island, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong Island, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Eliza Mi Ling Wong, PhD Chinese University of Hong Kong

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Responsible Party: Wong Mi Ling Eliza, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02350192     History of Changes
Other Study ID Numbers: 10110301
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wong Mi Ling Eliza, Chinese University of Hong Kong:
ehealth
intervention
effectiveness
randomized controlled trial
Additional relevant MeSH terms:
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Cardiovascular Diseases