LifestyleDo CHANGENCT02946281
Do Cardiac Health: Advanced New Generation Ecosystem
A study testing Do CHANGE in people with Lifestyle, run by Elisabeth-TweeSteden Ziekenhuis at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lifestyle
- What is being tested?
- Do CHANGE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Dec 2016to 22 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Lifestyle
- Being tested
- Do CHANGE
- Keywords
- self-management, health behavior, cardiac disease, habits, lifestyle
- Medical subject headings
- Health Behavior, Heart Diseases, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Do CHANGEBehavioural
Also called Do Something Different, Docobo Care Portal, Moves app, Blood pressure monitor UA -767 Plus
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Do CHANGE |
| Care as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifestyle
The Health Promoting Lifestyle Questionnaire (HPLP-II) will be administered to evaluate whether patients' subjective perception of lifestyle change has changed.
Measured: 0-6 months
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.
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 3 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start19 Dec 2016
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elisabeth-TweeSteden Ziekenhuis
- Sponsor type
- University, hospital or other
- Collaborators
- Eindhoven University of Technology, Smart Homes, Badalona Serveis Assistencials, Docobo Ltd., Do Something Different, Fundació Eurecat, ONMI, ITRII, Buddhist Tzu Chi General Hospital, European Commission
- Responsible party
- Principal investigator, Jos Widdershoven, Elisabeth-TweeSteden Ziekenhuis
- Investigators
- Jos Widdershoven, Prof. dr., Principal investigator, Elisabeth-TweeSteden Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946281
- Sponsor's protocol ID
- L0264.2016
- Acronym
- Do CHANGE
- Status last verified
- Jul 2018
- First submitted
- 7 Jul 2016
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35575702Broers 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.
PubMed 32441658
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Cardiac Health: Advanced New Generation Ecosystem
- ClinicalTrials.gov ID
- NCT02946281
- Acronym / sponsor ID
- Do CHANGE / L0264.2016
- Conditions
- Lifestyle
- Keywords
- self-management, health behavior, cardiac disease, habits, lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Elisabeth-TweeSteden ZiekenhuisUniversity, hospital or other
- Collaborators
- Eindhoven University of Technology, Smart Homes, Badalona Serveis Assistencials, Docobo Ltd., Do Something Different, Fundació Eurecat, ONMI, ITRII, Buddhist Tzu Chi General Hospital, European Commission
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Do CHANGE |
| Care as usual | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Do CHANGEAlso: Do Something Different, Docobo Care Portal, Moves app, Blood pressure monitor UA -767 PlusThe 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). | Behavioural | Intervention |
Primary outcome
Lifestyle
Time frame: 0-6 months
The Health Promoting Lifestyle Questionnaire (HPLP-II) will be administered to evaluate whether patients' subjective perception of lifestyle change has changed.
Behavioural flexibility
Time frame: 6 months
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.
Quality of life
Time frame: 6 months
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.
2 secondary outcomes
Usability, acceptance, satisfaction with intervention / tools
Time frame: 3 months
Cost-effectiveness
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Derived from this study: PubMed 35575702Habibovic 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.
- Derived from this study: PubMed 32441658Broers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jos Widdershoven, Prof. dr. principal investigator
Elisabeth-TweeSteden Ziekenhuis
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Do CHANGE in people with Lifestyle, run by Elisabeth-TweeSteden Ziekenhuis at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lifestyle (time frame: 0-6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02946281, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.