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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
Sponsor:
Collaborators:
Eindhoven University of Technology
Smart Homes
Badalona Serveis Assistencials
Docobo Ltd.
Do Something Different
Eurecat
ONMI
ITRII
Buddhist Tzu Chi General Hospital
European Commission
Information provided by (Responsible Party):
Jos Widdershoven, Elisabeth-TweeSteden Ziekenhuis

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.

Condition or disease Intervention/treatment Phase
Lifestyle Behavioral: Do CHANGE Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
Experimental: Intervention 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).
Other Names:
  • Do Something Different
  • Docobo Care Portal
  • Moves app
  • Blood pressure monitor UA -767 Plus

No Intervention: Care as usual



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. Depression [ Time Frame: 6 months ]
    The Patient Health Questionnaire (PHQ-9) will be use to assess depression within the sample.

  2. Anxiety [ Time Frame: 6 months ]
    The Generalized Anxiety Disorder (GAD-7) questionnaire will be used to assess the levels of anxiety.

  3. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • 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).

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)
  • 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).

Information from the National Library of Medicine

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


Locations
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Netherlands
Elisabeth-TweeSteden Hospital
Tilburg, Noord-Brabant, Netherlands
Spain
Badalona Serveis Assistencials
Badalona, Spain
Sponsors and Collaborators
Elisabeth-TweeSteden Ziekenhuis
Eindhoven University of Technology
Smart Homes
Badalona Serveis Assistencials
Docobo Ltd.
Do Something Different
Eurecat
ONMI
ITRII
Buddhist Tzu Chi General Hospital
European Commission
Investigators
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Principal Investigator: Jos Widdershoven, Prof. dr. Elisabeth-TweeSteden Hospital

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Responsible Party: Jos Widdershoven, Prof. Dr., Elisabeth-TweeSteden Ziekenhuis
ClinicalTrials.gov Identifier: NCT02946281     History of Changes
Other Study ID Numbers: L0264.2016
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Keywords provided by Jos Widdershoven, Elisabeth-TweeSteden Ziekenhuis:
self-management
health behavior
cardiac disease
habits
lifestyle