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

July 25, 2018 updated by: Jos Widdershoven, Elisabeth-TweeSteden Ziekenhuis
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08911
        • Badalona Serveis Assisstencials
  • Taiwan
      • Dalin, Taiwan, 62247
        • Buddhist Tzu Chi Dalin general hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Do Something Different
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elisabeth-TweeSteden Ziekenhuis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Buddhist Tzu Chi General Hospital
European Commission
Eindhoven University of Technology
The Industrial Technology Research Institute
Badalona Serveis Assistencials
Smart Homes
ONMI
Docobo Ltd.
Do Something Different

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jos Widdershoven, MD, PhD, Elisabeth-TweeSteden Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL61660.028.17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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