Do Cardiac Health: Advanced New Generation Ecosystem - Phase 2

Cardiovascular Diseases Clinical Trial

— Do CHANGE-2  

Official title:

Do Cardiac Health: Advanced New Generation Ecosystem - Phase 2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03178305
• Other study ID #: NL61660.028.17
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 27, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: July 2018
• Source: Elisabeth-TweeSteden Ziekenhuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Life Style
• Quality of Life

Intervention

Behavioral:
• Do CHANGE
Besides the behavior change programme (Do Something Different) All patients will receive: Fitbit, Beddit, Care-portal, Do CHANGE app (including dietary habits picture taking), CookiT (smart spatula that monitors cooking behavior) 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). 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.

Locations

Country	Name	City	State
Spain	Badalona Serveis Assisstencials	Badalona	Barcelona
Taiwan	Buddhist Tzu Chi Dalin general hospital	Dalin

Sponsors (10)

Lead Sponsor	Collaborator
Elisabeth-TweeSteden Ziekenhuis	Badalona Serveis Assistencials, Buddhist Tzu Chi General Hospital, Do Something Different, Docobo Ltd, Eindhoven University of Technology, European Commission, ONMI, Smart Homes, The Industrial Technology Research Institute

Countries where clinical trial is conducted

Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Identification of Subgroups that benefit	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
Other	Effects of intervention on physiological data	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
Primary	Lifestyle	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
Primary	Quality of Life (QoL)	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
Primary	Behavioral flexibility	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	Satisfaction, usability, and acceptance of the intervention	For this purpose the UTAUT-2 questionnaire will be used	6 months
Secondary	Cost effectiveness	the EQ-5D questionnaire will be administered in order to estimate the cost-effectivenss of the intervention.	6 months
Secondary	Health care utilization	Purpose designed questionnaires will be administered to assess health care utilization	6 months