Do Cardiac Health: Advanced New Generation Ecosystem – Phase 2

Overview

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.

Full Title of Study: “Do Cardiac Health: Advanced New Generation Ecosystem – Phase 2”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 31, 2018

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.

Interventions

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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 Measures

  • Satisfaction, usability, and acceptance of the intervention
    • Time Frame: 6 months
    • For this purpose the UTAUT-2 questionnaire will be used
  • Cost effectiveness
    • Time Frame: 6 months
    • the EQ-5D questionnaire will be administered in order to estimate the cost-effectivenss of the intervention.
  • Health care utilization
    • Time Frame: 6 months
    • Purpose designed questionnaires will be administered to assess health care utilization

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Elisabeth-TweeSteden Ziekenhuis
  • Collaborator
    • European Commission
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jos Widdershoven, Prof. Dr. – Elisabeth-TweeSteden Ziekenhuis
  • Overall Official(s)
    • Jos Widdershoven, MD, PhD, Principal Investigator, Elisabeth-TweeSteden Ziekenhuis

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