Do Cardiac Health: Advanced New Generation Ecosystem

Lifestyle Clinical Trial

— Do CHANGE  

Official title:

Do Cardiac Health: Advanced New Generation Ecosystem

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946281
• Other study ID #: L0264.2016
• Status: Completed
• Phase: N/A
• Start date: December 19, 2016
• Est. completion date: December 22, 2017

Study information

• Verified date: July 2018
• Source: Elisabeth-TweeSteden Ziekenhuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: December 22, 2017
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Lifestyle

Intervention

Behavioral:
• Do CHANGE
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).

Locations

Country	Name	City	State
Netherlands	Elisabeth-TweeSteden Hospital	Tilburg	Noord-Brabant
Spain	Badalona Serveis Assistencials	Badalona

Sponsors (11)

Lead Sponsor	Collaborator
Elisabeth-TweeSteden Ziekenhuis	Badalona Serveis Assistencials, Buddhist Tzu Chi General Hospital, Do Something Different, Docobo Ltd, Eindhoven University of Technology, Eurecat, European Commission, ITRII, ONMI, Smart Homes

Countries where clinical trial is conducted

Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression	The Patient Health Questionnaire (PHQ-9) will be use to assess depression within the sample.	6 months
Other	Anxiety	The Generalized Anxiety Disorder (GAD-7) questionnaire will be used to assess the levels of anxiety.	6 months
Other	Lifestyle data sensor generated	Patients' physical activity will be monitored (pedometer / active minutes per day) and evaluated by comparing their daily amount of steps / activity pre and post intervention.	3 months
Primary	Lifestyle	The Health Promoting Lifestyle Questionnaire (HPLP-II) will be administered to evaluate whether patients' subjective perception of lifestyle change has changed.	0-6 months
Primary	Behavioural flexibility	Whether the patients' behavioural flexibility (having a bigger behavioural repertoire which makes it easier to perform alternative behaviours) has increased and thus whether behaviour change (as conceptualized by Do Something Different program) has occurred will be assessed using purpose designed questions by the Do Something Different program.	6 months
Primary	Quality of life	Changes in quality of life will be assessed using the WHOQOL-Bref questionnaire. As this is a widely used instrument it will allow the integration of data from different partners.	6 months
Secondary	Usability, acceptance, satisfaction with intervention / tools	Unified Theory of Acceptance and Use of Technology (UTAUT2) questionnaire will be used to assess the usability, acceptance, and satisfaction of the care portal.	3 months
Secondary	Cost-effectiveness	Whether the intervention arm will be cost-effective as compared to the care as usual will be evaluated using the EQ-5D questionnaire. It could be expected that the intervention arm will experience a lower disease burden and be less likely to use additional health care resources.	6 months