Do Cardiac Health: Advanced New Generation Ecosystem - Phase 2 (Do CHANGE-2)

Elisabeth-TweeSteden Ziekenhuis

Status: Unknown

Conditions: Quality of Life; Life Style; Cardiovascular Diseases

Treatments: Behavioral: Do CHANGE

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03178305

NL61660.028.17

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Do CHANGE

Care as usual

No Intervention group

Description:

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