- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03178305
Do Cardiac Health: Advanced New Generation Ecosystem - Phase 2 (Do CHANGE-2)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Besides the behavior change programme (Do Something Different)
Data from these devices will be gathered and visible for patients (in patient portal) and for their health care provider (health care provider portal). In case of negative results the patient will be contacted by their health care provider (usually the cardiologist). Once every week the patients will be contacted to discuss their progress and will be given feedback about their dietary intake. |
Besides the behavior change programme (Do Something Different)
Data from these devices will be gathered and visible for patients (in patient portal) and for their health care provider (health care provider portal). In case of negative results the patient will be contacted by their health care provider (usually the cardiologist). Once every week the patients will be contacted to discuss their progress and will be given feedback about their dietary intake.
Other Names:
|
No Intervention: Care as usual
Patients in this arm will receive care as usual with no restrictions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lifestyle
Time Frame: 3 months
|
Lifestyle change will be measured with the HPLP-II questionnaire which assesses multiple domains of lifestyle.
This will make it possible to compare the two groups.
|
3 months
|
Quality of Life (QoL)
Time Frame: 3 months
|
Quality of life will be assessed with the WHOQoL-Bref which is a validated questionnaire and taps into different domains of quality of life.
|
3 months
|
Behavioral flexibility
Time Frame: 3 months
|
With the Do Something Different purpose designed questionnaire changes in behavioral flexibility will be measured.
This programme has previously shown to be effective in changing lifestyle behaviors among physically healthy subjects.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction, usability, and acceptance of the intervention
Time Frame: 6 months
|
For this purpose the UTAUT-2 questionnaire will be used
|
6 months
|
Cost effectiveness
Time Frame: 6 months
|
the EQ-5D questionnaire will be administered in order to estimate the cost-effectivenss of the intervention.
|
6 months
|
Health care utilization
Time Frame: 6 months
|
Purpose designed questionnaires will be administered to assess health care utilization
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of Subgroups that benefit
Time Frame: 6 months
|
Identifying subgroups of patients who are more likely to benefit from this type of approach.
Patients with certain demographic and/or psychological profile (Type D personality which will be measured with the DS14 questionnaire) might be more likely to benefit than others.
|
6 months
|
Effects of intervention on physiological data
Time Frame: 6 months
|
Measuring change in patients' physiological data (in the intervention group) in for example, sleep patterns or patients' ECGs, as a result of the intervention.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jos Widdershoven, MD, PhD, Elisabeth-TweeSteden hospital
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL61660.028.17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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