Do Cardiac Health: Advanced New Generation Ecosystem
Condition: Lifestyle
Study type: Interventional

Summary: 
      The primary objective of Do CHANGE is to develop a health ecosystem for integrated disease
      management of citizens with high blood pressure and patients with ischemic heart disease or
      heart failure. The system will give them access to a set of personalized health services in a
      near real-time fashion. This disruptive system will incorporate the behaviour change methods,
      such as "Do Something Different", in conjunction with new innovative wearable/portable tools
      that can monitor behaviour and clinical parameters in normal living situations.
    

Detailed description: 
      Patients enrolled for participation will be randomly assigned to the intervention or 'care as
      usual' group (1:1). Patients assigned to the intervention group will receive a 3 month
      intervention aiming to enhance self-management and lifestyle.

      The intervention will consist out 4 components.

        1. Behavioral prompts (Do's) from the Do Something Different Programme The Do Something
           Different Program has previously been developed and evaluated (ref). For the current
           study, the programme has been adapted to the population of interest (CAD, HF, and HT
           patients) together with behavioural experts and cardiologists. The program aims to
           change behavioural habits and increase flexibility and subsequently change habits
           associated with an unhealthy lifestyle and distress, which are both found to be
           associated with hypertension and cardiovascular risks. The program has been developed
           with input from cardiologists , psychologists, and patients. 'Typical' other behavioural
           risks besides hypertension have been identified and are addressed within the program. To
           further adapt the program to patient' needs, all patient, prior to starting the program,
           will be assessed regarding their own functioning, distress, and personality such that
           the Do's will match their personal habits and challenge them to change.

           After assessing patients personality profile the intervention will be provided for 11
           weeks. Patients will receive a total of 32 Do's / messages during this period. The Do's
           will be matched to their personal profile.

        2. Care-Portal All patients who are randomized to the intervention group will also receive
           a Care-Portal (Docobo Ltd.) which will be installed at their home. The Care-Portal will
           be used to gather ECG data and blood pressure on a daily basis. The Care-Portal will
           send the physiological data directly to the cardiologist who will be able to access
           those via an online platform and contact the patient if necessary.

           In addition, patients will receive their Do's trough the care-portal. The Care-Portal is
           a CE-marked device that has previously been successfully used and implemented to support
           patients with chronic conditions.

        3. Blood pressure monitor All patients in the intervention group will receive the digital
           blood pressure monitor 'UA -767 Plus' which is a CE-marked device for clinical use.
           Patients will be asked to measure their blood pressure on a daily basis and record the
           values through the care-portal.

        4. Moves App For the future study within the Do CHANGE project, the Do Something Different
           programme wants to focus on providing 'Contextual Do's' where patients will receive
           behavioural prompts at the moment that the behaviour takes place. In order to reach this
           goal getting more insight in patients behavioral patters is of utmost importance. Hence,
           that data will be gathered within this current study as one of the exploratory
           objectives using GPS data. This will give more insights and will be used as input for
           future study. All patients participating in the intervention will be provided with the
           'Moves' app that will log their activities anonymously. This information will
           automatically be available for research purposes only. Patients will not receive any
           push messages from that app or any feedback.

      "Moves" is an automatic diary of patients life. The daily storyline and maps show where,
      when, and how much a person moves. The application automatically records any walking,
      cycling, and running that is done. The app is always active in the background, so there's no
      need to start and stop it. Just keep the phone in the pocket or a bag. The app consumes
      battery power, so nightly charging is recommended. With typical phone use, a smartphone
      running Moves should have enough battery power to last all day. The optional Battery Saving
      Mode in Moves for iPhone saves up to 40% of battery.

      The Moves API can be used to build new apps, integrate with an existing service and visualise
      data. The API is designed for apps and services that have a server component. Individual
      users need to give permission to access data. However, providing any kind of personal
      information is optional, data collection can be done anonymously as well. Moves uses OAuth
      2.0 for authentication and authorization and the actual authorization happens in the Moves
      app.

      During this study the API can be used to collect location based data from participants. This
      data will be used to develop the location based responsive Do program. During the study
      participants will not receive feedback from the application. In the settings all
      notifications can be turned off. Besides, the app can be used without setting goals and
      accounts. The only thing a participant is asked is to install the app and fill in a unique
      code for data collection. Participants who do not use a smartphone or are not able to install
      the app do not have to use it.
    

Intervention name(s): Do CHANGE
Intervention type(s): Behavioral
Intervention description(s): The intervention aims to increase behavioral flexibility and change patients' (unhealthy) lifestyle. At the same time the intervention should increase patient self-management and improve the patient reported outcomes (e.g. quality of life, anxiety, depression).
Other intervention name(s): Do Something Different; Docobo Care Portal; Moves app; Blood pressure monitor UA -767 Plus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: self-management; health behavior; cardiac disease; habits; lifestyle