Clinical trial NCT02946281: Do Cardiac Health: Advanced New Generation Ecosystem
Official title: Do Cardiac Health: Advanced New Generation Ecosystem
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lifestyle
Keywords: self-management
health behavior
cardiac disease
habits
lifestyle
Lead sponsor: Elisabeth-TweeSteden Ziekenhuis
Sponsor class: OTHER
Collaborators: name: Eindhoven University of Technology
name: Smart Homes
name: Badalona Serveis Assistencials
name: Docobo Ltd.
name: Do Something Different
name: Fundació Eurecat
name: ONMI
name: ITRII
name: Buddhist Tzu Chi General Hospital
name: European Commission
First posted: 2016-10-27
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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)
* Patients should have sufficient knowledge of the countries' native language.
* Additional inclusion criteria for HF patients only is to have a left ejection fraction of ≤35% 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)
* 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).

Primary outcomes:
measure: Lifestyle
timeFrame: 0-6 months
measure: Behavioural flexibility
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
Secondary outcomes:
measure: Usability, acceptance, satisfaction with intervention / tools
timeFrame: 3 months
measure: Cost-effectiveness
timeFrame: 6 months
Other outcomes:
measure: Depression
timeFrame: 6 months
measure: Anxiety
timeFrame: 6 months
measure: Lifestyle data sensor generated
timeFrame: 3 months
Locations:
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Hospital
state: Noord-Brabant
city: Badalona
country: Spain
facility: Badalona Serveis Assistencials
Study officials:
affiliation: Elisabeth-TweeSteden Ziekenhuis
name: Jos Widdershoven, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Habibovic M, Piera-Jimenez J, Wetzels M, Widdershoven JWGM, Soedamah-Muthu SS. Associations between behavioral flexibility and health behavior in cardiac patients in the Do CHANGE trials. Health Psychol. 2022 Oct;41(10):710-718. doi: 10.1037/hea0001151. Epub 2022 May 16.
citation: Broers ER, Kop WJ, Denollet J, Widdershoven J, Wetzels M, Ayoola I, Piera-Jimenez J, Habibovic M. A Personalized eHealth Intervention for Lifestyle Changes in Patients With Cardiovascular Disease: Randomized Controlled Trial. J Med Internet Res. 2020 May 22;22(5):e14570. doi: 10.2196/14570.