Do Cardiac Health: Advanced New Generation Ecosystem
Do CHANGE
1 other identifier
interventional
149
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2016
CompletedFirst Posted
Study publicly available on registry
October 27, 2016
CompletedStudy Start
First participant enrolled
December 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2017
CompletedJuly 26, 2018
July 1, 2018
1 year
July 7, 2016
July 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (2)
Usability, acceptance, satisfaction with intervention / tools
3 months
Cost-effectiveness
6 months
Other Outcomes (3)
Depression
6 months
Anxiety
6 months
Lifestyle data sensor generated
3 months
Study Arms (2)
Intervention
EXPERIMENTALCare as usual
NO INTERVENTIONInterventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elisabeth-TweeSteden Ziekenhuislead
- Eindhoven University of Technologycollaborator
- Smart Homescollaborator
- Badalona Serveis Assistencialscollaborator
- Docobo Ltd.collaborator
- Do Something Differentcollaborator
- Fundació Eurecatcollaborator
- ONMIcollaborator
- ITRIIcollaborator
- Buddhist Tzu Chi General Hospitalcollaborator
- European Commissioncollaborator
Study Sites (2)
Elisabeth-TweeSteden Hospital
Tilburg, North Brabant, Netherlands
Badalona Serveis Assistencials
Badalona, Spain
Related Publications (2)
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.
PMID: 35575702DERIVEDBroers 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.
PMID: 32441658DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jos Widdershoven, Prof. dr.
Elisabeth-TweeSteden Ziekenhuis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
July 7, 2016
First Posted
October 27, 2016
Study Start
December 19, 2016
Primary Completion
December 22, 2017
Study Completion
December 22, 2017
Last Updated
July 26, 2018
Record last verified: 2018-07