Clinical trial NCT03178305: Do Cardiac Health: Advanced New Generation Ecosystem - Phase 2
Official title: Do Cardiac Health: Advanced New Generation Ecosystem - Phase 2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Life Style
Quality of Life
Lead sponsor: Elisabeth-TweeSteden Ziekenhuis
Sponsor class: OTHER
Collaborators: name: European Commission
name: Badalona Serveis Assistencials
name: Smart Homes
name: ONMI
name: Eindhoven University of Technology
name: Docobo Ltd.
name: Do Something Different
name: Buddhist Tzu Chi General Hospital
name: The Industrial Technology Research Institute
First posted: 2017-06-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial where patients will be randomly (2:2) assigned to the intervention vs control group.
Primary purpose: PREVENTION

Brief summary: The Do CHANGE service is designed for cardiac patients who could benefit from lifestyle change and a better disease management. The study aims to support patients with behavior change by providing them with devices and behavioral intervention in order to facilitate long-term behavior change.

Detailed description: The focus of the Do CHANGE project is on empowering individuals with high blood pressure, ischemic heart disease or heart failure with tools and services to optimally monitor and manage their real-time health condition and disease. The innovative approach of the Do CHANGE project also involves the patients' surrounding health ecosystem in the process. The traditional difficulties of therapy adherence in a physician-centred care system are radically abandoned and replaced by a patient-centred approach. The approach advocated by Do CHANGE project focuses on the needs of the patient by not only providing them with innovative tools that assess the patient's real-time health condition, but also offer a variety of behavioural alternatives. The main hypothesis of the Do CHANGE project is that patients' disease self-management and lifestyle will improve as compared to self-management of patients who receive the care as usual.

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)
* sufficient knowledge of the countries' native language.
* Additional inclusion criteria for HF patients only is to have a previous diagnosis of systolic or diastolic heart failure 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),
* a 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: 3 months
measure: Quality of Life (QoL)
timeFrame: 3 months
measure: Behavioral flexibility
timeFrame: 3 months
Secondary outcomes:
measure: Satisfaction, usability, and acceptance of the intervention
timeFrame: 6 months
measure: Cost effectiveness
timeFrame: 6 months
measure: Health care utilization
timeFrame: 6 months
Other outcomes:
measure: Identification of Subgroups that benefit
timeFrame: 6 months
measure: Effects of intervention on physiological data
timeFrame: 6 months
Locations:
city: Badalona
country: Spain
facility: Badalona Serveis Assisstencials
state: Barcelona
city: Dalin
country: Taiwan
facility: Buddhist Tzu Chi Dalin general hospital
Study officials:
affiliation: Elisabeth-TweeSteden Ziekenhuis
name: Jos Widdershoven, MD, PhD
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: Piera-Jimenez J, Winters M, Broers E, Valero-Bover D, Habibovic M, Widdershoven JWMG, Folkvord F, Lupianez-Villanueva F. Changing the Health Behavior of Patients With Cardiovascular Disease Through an Electronic Health Intervention in Three Different Countries: Cost-Effectiveness Study in the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) 2 Randomized Controlled Trial. J Med Internet Res. 2020 Jul 28;22(7):e17351. doi: 10.2196/17351.
citation: Habibovic M, Gavidia G, Broers E, Wetzels M, Ayoola I, Ribas V, Piera-Jimenez J, Widdershoven J, Denollet J. Type D personality and global positioning system tracked social behavior in patients with cardiovascular disease. Health Psychol. 2020 Aug;39(8):711-720. doi: 10.1037/hea0000823. Epub 2020 Apr 16.
citation: Broers ER, Widdershoven J, Denollet J, Lodder P, Kop WJ, Wetzels M, Ayoola I, Piera-Jimenez J, Habibovic M; Do CHANGE Consortium. Personalized eHealth Program for Life-style Change: Results From the "Do Cardiac Health Advanced New Generated Ecosystem (Do CHANGE 2)" Randomized Controlled Trial. Psychosom Med. 2020 May;82(4):409-419. doi: 10.1097/PSY.0000000000000802.
citation: Broers ER, Gavidia G, Wetzels M, Ribas V, Ayoola I, Piera-Jimenez J, Widdershoven JWMG, Habibovic M; Do CHANGE consortium. Usefulness of a Lifestyle Intervention in Patients With Cardiovascular Disease. Am J Cardiol. 2020 Feb 1;125(3):370-375. doi: 10.1016/j.amjcard.2019.10.041. Epub 2019 Nov 6.
citation: Habibovic M, Broers E, Piera-Jimenez J, Wetzels M, Ayoola I, Denollet J, Widdershoven J. Enhancing Lifestyle Change in Cardiac Patients Through the Do CHANGE System ("Do Cardiac Health: Advanced New Generation Ecosystem"): Randomized Controlled Trial Protocol. JMIR Res Protoc. 2018 Feb 8;7(2):e40. doi: 10.2196/resprot.8406.