Healthy Living With Online suPport & Education for Cardiovascular Disease in the Primary Care Setting
NCT ID: NCT06099353
Last Updated: 2024-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1500 participants
INTERVENTIONAL
2024-01-18
2024-10-30
Brief Summary
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The primary objective of our study is to evaluate the impact of each intervention arm compared to usual care (Arm 1) on the risk for CVD, using change in low-density lipoprotein cholesterol (LDL) measurements as the outcome measure. The secondary objective is to evaluate the impact of each intervention arm compared to usual care (Arm 1) on the following: (a) individual CVD risk factors (i.e. blood pressure, total cholesterol, high-density lipoprotein, body mass index, smoking status, fasting blood glucose or glycated haemoglobin, diagnosis of diabetes, triglycerides level), (b) risk for CVD (i.e., estimated using the Framingham Risk Score), (c) health-related quality of life and well-being, and (d) practice of health-promoting behaviours.
The Heart Age-HOPE-CVD app is a 6-month interventional programme. Hence, the effects of the interventions will be evaluated after a 6-month period. Patients will be recruited by general practitioners (GPs) at primary care clinics around Singapore. After obtaining informed consent at baseline, patients' data will be collected at four time points: baseline, mid-intervention at week 6, post-intervention health screening at week 24 and post-intervention at week 26. All data collection will be conducted at the primary care clinic, except for mid-intervention data which will be collected via an online form.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm 1: Usual Care
* General practitioners' (GPs) usual care for patients.
* GPs will direct patient participants to a publicly available webpage about managing CVD risk on the Health Promotion Board website.
No interventions assigned to this group
Arm 2: Heart Age only
* General practitioners' (GPs) usual care for patients.
* GPs will direct patient participants to a publicly available webpage about managing CVD risk on the Health Promotion Board website.
* GPs will also show patient participants how to access Heart Age, a risk assessment tool available online and communicate with them their respective Heart Age value.
Heart Age
Heart Age is the phenotypic age based on the risk of the patient participant using a modified tool for CVD risk from the Framingham risk Score. The Heart Age is the age at which an individual would be expected to develop CVD in the next ten years relative to another individual of the same sex and age if all the current CVD risk factors were to be eliminated.
Arm 3: Heart Age and Heart Age-HOPE-CVD app
* General practitioners' (GPs) usual care for patients.
* GPs will direct patient participants to a publicly available webpage about managing CVD risk on the Health Promotion Board website.
* GPs will show patient participants how to access Heart Age, a risk assessment tool available online and communicate with them their respective Heart Age value.
* GPs will also direct patient participants to download the Heart Age-HOPE- CVD mobile app, an evidence-based behaviour change digital platform.
Heart Age
Heart Age is the phenotypic age based on the risk of the patient participant using a modified tool for CVD risk from the Framingham risk Score. The Heart Age is the age at which an individual would be expected to develop CVD in the next ten years relative to another individual of the same sex and age if all the current CVD risk factors were to be eliminated.
Heart Age-HOPE-CVD App
Patient participants will use an online mobile, evidence-based behavioural change psychoeducation application for 24 weeks. New psychoeducational content is released every week. The first seven weeks of the programme seeks to resolve ambivalence about initiating a lifestyle change and increase the readiness and motivation to change. Between Weeks 8 and 15, the platform will support action planning and guide users to execute their preferred self-care behaviour safely and effectively. The remaining nine weeks will provide the user with the skills that will help them with coping and planning to manage relapses and temptations.
Arm 4: Heart Age, HOPE-CVD app, and genetic risk communication
* General practitioners' (GPs) usual care for patients.
* GPs will direct patient participants to a publicly available webpage about managing CVD risk on the Health Promotion Board website.
* GPs will show patient participants how to access Heart Age, a risk assessment tool available online and communicate with them their respective Heart Age value.
* GPs will direct patient participants to download the Heart Age-HOPE- CVD mobile app, an evidence-based behaviour change digital platform.
* Patient participants will undergo genetic testing from which a genetic risk score for CVD will be estimated. They will be informed which quartile of genetic risk they are at in comparison to the rest of the population. The report also contains information on what this risk means for their chances of developing cardiovascular disease in the future.
Heart Age
Heart Age is the phenotypic age based on the risk of the patient participant using a modified tool for CVD risk from the Framingham risk Score. The Heart Age is the age at which an individual would be expected to develop CVD in the next ten years relative to another individual of the same sex and age if all the current CVD risk factors were to be eliminated.
Heart Age-HOPE-CVD App
Patient participants will use an online mobile, evidence-based behavioural change psychoeducation application for 24 weeks. New psychoeducational content is released every week. The first seven weeks of the programme seeks to resolve ambivalence about initiating a lifestyle change and increase the readiness and motivation to change. Between Weeks 8 and 15, the platform will support action planning and guide users to execute their preferred self-care behaviour safely and effectively. The remaining nine weeks will provide the user with the skills that will help them with coping and planning to manage relapses and temptations.
Communication of Genetic Risk Score
General practitioners will draw 3ml of blood from each patient participant for analysis of the patient's genetic risk score of having cardiovascular disease. This genetic risk score will be communicated to the patient, and the communication will include informing patients what cardiovascular disease genetic risk is, what their genetic risk category compared to the population in Singapore is, and what their score means for the future.
Interventions
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Heart Age
Heart Age is the phenotypic age based on the risk of the patient participant using a modified tool for CVD risk from the Framingham risk Score. The Heart Age is the age at which an individual would be expected to develop CVD in the next ten years relative to another individual of the same sex and age if all the current CVD risk factors were to be eliminated.
Heart Age-HOPE-CVD App
Patient participants will use an online mobile, evidence-based behavioural change psychoeducation application for 24 weeks. New psychoeducational content is released every week. The first seven weeks of the programme seeks to resolve ambivalence about initiating a lifestyle change and increase the readiness and motivation to change. Between Weeks 8 and 15, the platform will support action planning and guide users to execute their preferred self-care behaviour safely and effectively. The remaining nine weeks will provide the user with the skills that will help them with coping and planning to manage relapses and temptations.
Communication of Genetic Risk Score
General practitioners will draw 3ml of blood from each patient participant for analysis of the patient's genetic risk score of having cardiovascular disease. This genetic risk score will be communicated to the patient, and the communication will include informing patients what cardiovascular disease genetic risk is, what their genetic risk category compared to the population in Singapore is, and what their score means for the future.
Eligibility Criteria
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Inclusion Criteria
* Based in Singapore for the duration of study participation (i.e., 6 months)
* Able to read and understand English
* Have access to and is comfortable using a smartphone
* For patients with diabetes, their LDL has to be at least 2.6 mmol/L
* For patients without diabetes, their LDL has to be at least 3.4 mmol/L
Exclusion Criteria
* Patients diagnosed with chronic kidney disease: i.e., eGFR \<60ml/min/1.73㎡ OR uACR ≥ 3mg/mmol (30mg/g) OR uPCR \>15mg/mmol (150mg/g)
* Patients with serious mental illness (i.e., require assistance in daily activities due to the mental illness)
* Pregnant or planning to be pregnant in the next six months
* Unable to give informed consent
* Diagnosed with a terminal illness or expected life expectancy of less than 12 months
* Patients with triglyceride levels of ≥ 4.5 mmol/L
* Patients on chemotherapy course during the study or less than one month prior to participating in the study
* Patients on long-term oral steroids
* Patients who are already involved in other HOPE studies (e.g. HOPE-Virtual study)
30 Years
74 Years
ALL
Yes
Sponsors
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National University of Singapore
OTHER
National University Health System, Singapore
OTHER
Nanyang Technological University
OTHER
Responsible Party
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Lee Eng Sing
Assistant Professor
Principal Investigators
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Eng Sing Lee
Role: PRINCIPAL_INVESTIGATOR
Nanyang Technological University
Locations
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Lee Kong Chian School of Medicine, NTU
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Eng Sing Lee
Role: primary
Other Identifiers
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IRB-2022-928
Identifier Type: -
Identifier Source: org_study_id
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