Cardiovascular DiseaseNCT02350192
Effectiveness of an E-health Educational Intervention for Cardiovascular Disease Adults in Improving Outcomes
A study testing e-health educational intervention (eHEI) in people with Cardiovascular Disease, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- e-health educational intervention (eHEI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 2 sitesHong Kong
- Study dates
- Jun 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- those with physical, mental, visual, or cognitive impairments as recorded in their health records
- those who have contra-indications to walking.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Tung Wah Eastern Hospital
Causeway Bay, Hong Kong Island
Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong Island
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- e-health educational intervention (eHEI)
- Keywords
- ehealth, intervention, effectiveness, randomized controlled trial
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-health educational intervention (eHEI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in total physical exercise (measured by The Godin-Shephard Leisure-Time Physical Activity Questionnaire)
Change in physical exercise is
Measured: 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)
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.
Measured: 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?)
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?
Measured: Baseline, 3 Months, 6 Months
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.
Measured: Baseline, 3 Months, 6 Months
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.
Measured: Baseline, 3 Months, 6 Months
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.
Measured: Baseline, 3 Months, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startJun 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Mi Ling Eliza, Chinese University of Hong Kong
- Investigators
- Eliza Mi Ling Wong, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350192
- Sponsor's protocol ID
- 10110301
- Status last verified
- Jul 2016
- First submitted
- 21 Jan 2015
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02350192
- Acronym / sponsor ID
- 10110301
- Conditions
- Cardiovascular Disease
- Keywords
- ehealth, intervention, effectiveness, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e-health educational intervention (eHEI) | Experimental | Behavioral: 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. |
| 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- those with physical, mental, visual, or cognitive impairments as recorded in their health records
- those who have contra-indications to walking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | e-health educational intervention (eHEI) |
Primary outcome
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
5 secondary outcomes
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
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
Changes in anxiety and depression (Chinese version of the Hospital anxiety and depression scale)
Time frame: Baseline, 3 Months, 6 Months
Changes in quality of Life (Chinese version of the health survey questionnaire (SF-12)
Time frame: Baseline, 3 Months, 6 Months
Cardiac risk factor profile (Demographic data will be collected through questionnaire)
Time frame: Baseline, 3 Months, 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliza Mi Ling Wong, PhD principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-health educational intervention (eHEI) in people with Cardiovascular Disease, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in total physical exercise (measured by The Godin-Shephard Leisure-Time Physical Activity Questionnaire) (time frame: Baseline, 3 Months, 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.