Do Cardiac Health: Advanced New Generation Ecosystem

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-27

Study Completion Date

2018-07-31

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.

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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.

Conditions

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Cardiovascular Diseases Life Style Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial where patients will be randomly (2:2) assigned to the intervention vs control group.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Besides the behavior change programme (Do Something Different)

1. All patients will receive: Fitbit, Beddit, Care-portal, Do CHANGE app (including dietary habits picture taking), CookiT (smart spatula that monitors cooking behavior)
2. 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).
3. 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.

Group Type EXPERIMENTAL

Do CHANGE

Intervention Type BEHAVIORAL

Besides the behavior change programme (Do Something Different)

1. All patients will receive: Fitbit, Beddit, Care-portal, Do CHANGE app (including dietary habits picture taking), CookiT (smart spatula that monitors cooking behavior)
2. 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).
3. 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.

Care as usual

Patients in this arm will receive care as usual with no restrictions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Do CHANGE

Besides the behavior change programme (Do Something Different)

1. All patients will receive: Fitbit, Beddit, Care-portal, Do CHANGE app (including dietary habits picture taking), CookiT (smart spatula that monitors cooking behavior)
2. 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).
3. 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Do Something Different

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.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No