Do Cardiac Health: Advanced New Generation Ecosystem - Phase 2

Study Overview
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Brief Summary
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The Do CHANGE service is designed for cardiac patients who could benefit from lifestyle change and a better disease management. The study aims to support patients with behavior change by providing them with devices and behavioral intervention in order to facilitate long-term behavior change.

Detailed Description
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The focus of the Do CHANGE project is on empowering individuals with high blood pressure, ischemic heart disease or heart failure with tools and services to optimally monitor and manage their real-time health condition and disease. The innovative approach of the Do CHANGE project also involves the patients' surrounding health ecosystem in the process. The traditional difficulties of therapy adherence in a physician-centred care system are radically abandoned and replaced by a patient-centred approach. The approach advocated by Do CHANGE project focuses on the needs of the patient by not only providing them with innovative tools that assess the patient's real-time health condition, but also offer a variety of behavioural alternatives. The main hypothesis of the Do CHANGE project is that patients' disease self-management and lifestyle will improve as compared to self-management of patients who receive the care as usual.

Official Title
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Do Cardiac Health: Advanced New Generation Ecosystem - Phase 2

Conditions
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Cardiovascular Diseases, Life Style, Quality of Life

Intervention / Treatment
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* Behavioral: Do CHANGE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-75 years diagnosed with CAD, HF or HT having at least two of the following risk factors: smoking, positive family history, increased cholesterol, diabetes, sedentary lifestyle, psychosocial risk factors. Patients should also have access to the Internet and have a smartphone (and sufficient knowledge on using personal computer or smartphone) sufficient knowledge of the countries' native language. Additional inclusion criteria for HF patients only is to have a previous diagnosis of systolic or diastolic heart failure and experience HF symptoms (e.g. shortness of breath, chest pain, exhaustion). Exclusion Criteria: significant cognitive impairments (e.g. dementia) patients who are on the waiting list for heart transplantation life expectancy <1 year life threatening comorbidities (e.g. cancers), a history of psychiatric illness other than anxiety/depression patients who do not have access to internet patients with insufficient knowledge of the local pilot language (Dutch, Chinese and Catalonian).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial where patients will be randomly (2:2) assigned to the intervention vs control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Besides the behavior change programme (Do Something Different) All patients will receive: Fitbit, Beddit, Care-portal, Do CHANGE app (including dietary habits picture taking), CookiT (smart spatula that monitors cooking behavior) patients with heart failure will, in addition to the above mentioned, be offered a weight scale, blood pressure monitor, and FluiT (smart cup to measure fluid intake). Patients with hypertension will also be offered a bloodpressure monitor. Data from these devices will be gathered and visible for patients (in patient portal) and for their health care provider (health care provider portal). In case of negative results the patient will be contacted by their health care provider (usually the cardiologist). Once every week the patients will be contacted to discuss their progress and will be given feedback about their dietary intake. | Behavioral: Do CHANGE<br>* Besides the behavior change programme (Do Something Different) All patients will receive: Fitbit, Beddit, Care-portal, Do CHANGE app (including dietary habits picture taking), CookiT (smart spatula that monitors cooking behavior) patients with heart failure will, in addition to the above mentioned, be offered a weight scale, blood pressure monitor, and FluiT (smart cup to measure fluid intake). Patients with hypertension will also be offered a bloodpressure monitor. Data from these devices will be gathered and visible for patients (in patient portal) and for their health care provider (health care provider portal). In case of negative results the patient will be contacted by their health care provider (usually the cardiologist). Once every week the patients will be contacted to discuss their progress and will be given feedback about their dietary intake.<br>* Other names: Do Something Different;|
| No Intervention: Care as usual<br>Patients in this arm will receive care as usual with no restrictions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lifestyle | Lifestyle change will be measured with the HPLP-II questionnaire which assesses multiple domains of lifestyle. This will make it possible to compare the two groups. | 3 months | 
| Quality of Life (QoL) | Quality of life will be assessed with the WHOQoL-Bref which is a validated questionnaire and taps into different domains of quality of life. | 3 months | 
| Behavioral flexibility | With the Do Something Different purpose designed questionnaire changes in behavioral flexibility will be measured. This programme has previously shown to be effective in changing lifestyle behaviors among physically healthy subjects. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction, usability, and acceptance of the intervention | For this purpose the UTAUT-2 questionnaire will be used | 6 months | 
| Cost effectiveness | the EQ-5D questionnaire will be administered in order to estimate the cost-effectivenss of the intervention. | 6 months | 
| Health care utilization | Purpose designed questionnaires will be administered to assess health care utilization | 6 months |