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Do Cardiac Health: Advanced New Generation Ecosystem - Phase 2 (Do CHANGE-2)

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: NCT03178305
Recruitment Status : Active, not recruiting
First Posted : June 6, 2017
Last Update Posted : July 26, 2018
Sponsor:
Collaborators:
European Commission
Badalona Serveis Assistencials
Smart Homes
ONMI
Eindhoven University of Technology
Docobo Ltd.
Do Something Different
Buddhist Tzu Chi General Hospital
The Industrial Technology Research Institute
Information provided by (Responsible Party):
Jos Widdershoven, Elisabeth-TweeSteden Ziekenhuis

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Life Style Quality of Life Behavioral: Do CHANGE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial where patients will be randomly (2:2) assigned to the intervention vs control group.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Do Cardiac Health: Advanced New Generation Ecosystem - Phase 2
Actual Study Start Date : July 27, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

Arm Intervention/treatment
Experimental: Intervention

Besides the behavior change programme (Do Something Different)

  1. All patients will receive: Fitbit, Beddit, Care-portal, Do CHANGE app (including dietary habits picture taking), CookiT (smart spatula that monitors cooking behavior)
  2. patients with heart failure will, in addition to the above mentioned, be offered a weight scale, blood pressure monitor, and FluiT (smart cup to measure fluid intake).
  3. Patients with hypertension will also be offered a bloodpressure monitor.

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.

Behavioral: Do CHANGE

Besides the behavior change programme (Do Something Different)

  1. All patients will receive: Fitbit, Beddit, Care-portal, Do CHANGE app (including dietary habits picture taking), CookiT (smart spatula that monitors cooking behavior)
  2. patients with heart failure will, in addition to the above mentioned, be offered a weight scale, blood pressure monitor, and FluiT (smart cup to measure fluid intake).
  3. Patients with hypertension will also be offered a bloodpressure monitor.

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 Name: Do Something Different

No Intervention: Care as usual
Patients in this arm will receive care as usual with no restrictions.



Primary Outcome Measures :
  1. 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.

  2. 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. 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.


Secondary Outcome Measures :
  1. Satisfaction, usability, and acceptance of the intervention [ Time Frame: 6 months ]
    For this purpose the UTAUT-2 questionnaire will be used

  2. Cost effectiveness [ Time Frame: 6 months ]
    the EQ-5D questionnaire will be administered in order to estimate the cost-effectivenss of the intervention.

  3. Health care utilization [ Time Frame: 6 months ]
    Purpose designed questionnaires will be administered to assess health care utilization


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

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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)
  • 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).

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): NCT03178305


Locations
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Spain
Badalona Serveis Assisstencials
Badalona, Barcelona, Spain, 08911
Taiwan
Buddhist Tzu Chi Dalin general hospital
Dalin, Taiwan, 62247
Sponsors and Collaborators
Elisabeth-TweeSteden Ziekenhuis
European Commission
Badalona Serveis Assistencials
Smart Homes
ONMI
Eindhoven University of Technology
Docobo Ltd.
Do Something Different
Buddhist Tzu Chi General Hospital
The Industrial Technology Research Institute
Investigators
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Principal Investigator: Jos Widdershoven, MD, PhD Elisabeth-TweeSteden Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jos Widdershoven, Prof. Dr., Elisabeth-TweeSteden Ziekenhuis
ClinicalTrials.gov Identifier: NCT03178305     History of Changes
Other Study ID Numbers: NL61660.028.17
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases