Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02946281|
Recruitment Status : Completed
First Posted : October 27, 2016
Last Update Posted : July 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lifestyle||Behavioral: Do CHANGE||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||149 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Do Cardiac Health: Advanced New Generation Ecosystem|
|Actual Study Start Date :||December 19, 2016|
|Actual Primary Completion Date :||December 22, 2017|
|Actual Study Completion Date :||December 22, 2017|
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).
|No Intervention: Care as usual|
- 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.
- Usability, acceptance, satisfaction with intervention / tools [ Time Frame: 3 months ]Unified Theory of Acceptance and Use of Technology (UTAUT2) questionnaire will be used to assess the usability, acceptance, and satisfaction of the care portal.
- Cost-effectiveness [ Time Frame: 6 months ]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.
- Depression [ Time Frame: 6 months ]The Patient Health Questionnaire (PHQ-9) will be use to assess depression within the sample.
- Anxiety [ Time Frame: 6 months ]The Generalized Anxiety Disorder (GAD-7) questionnaire will be used to assess the levels of anxiety.
- Lifestyle data sensor generated [ Time Frame: 3 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946281
|Tilburg, Noord-Brabant, Netherlands|
|Badalona Serveis Assistencials|
|Principal Investigator:||Jos Widdershoven, Prof. dr.||Elisabeth-TweeSteden Hospital|