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Do Cardiac Health Advanced New Generation Ecosystem 2

Do Cardiac Health Advanced New Generation Ecosystem 2 - Do CHANGE 2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44217
Enrollment
75
Registered
2017-07-27
Start date
2017-07-02
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac disease Heart disease

Interventions

1. Do Something Different programme All patients randomized to the intervention group will receive the Do Something Different online programme which has been developed to change behavioural habits
Cardiac disease
eHealth
Health behavior
Lifestyle

Sponsors

Badalona Serveis Assisstencials
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Age 18-75 years, diagnosed with CAD, HF or hypertension, having at least two of the following risk factors: smoking, positive family history, hypertension, increased cholesterol, diabetes, sedentary lifestyle, psychosocial risk factors. Patients should also have access to the Internet and have a smartphone (and sufficient knowledge on how to use a personal computer or smartphone), and have sufficient knowledge of the countries' native language. Additional inclusion criterium for HF patients only is to experience HF symptoms (e.g. shortness of breath, chest pain, exhaustion)

Exclusion criteria

Exclusion criteria: Significant cognitive impairment (e.g. dementia), patients who are on the waitinglist for heart transplantation, life expectancy

Design outcomes

Primary

MeasureTime frame
In order for the intervention to be perceived as effective for patients it is important that behaviour changed leading to a healthy lifestyle is accomplished. In addition, an improvement in the patient reported outcomes (quality of life, anxiety-depression) would also indicate a clinical effect of the intervention. Lifestyle: Changes in patients' lifestyle will be assessed by comparing (pre-post treatment) the sensor data from the tools that are used in the intervention. In addition, the HEalth Promoting Lifestyle Questionnaire (HPLP-II) will be administered to evaluate whether patients' subjective perception of lifestyle change has changed. Behavioural flexibility: 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 programme) has occured will be assessed using purpose designed questions by the Do Something Different programme. Quality of life: Changes in quality of life will be assessed using the EuroQol-5D questionnaire. As thisis a widely used instrument it will allow us to integrate data from different partners.

Secondary

MeasureTime frame
Satisfaction with intervention: Whether patients were satisfied with the intervention in general, purpose designed questions will be administered. Usability of the tools: To measure the perceived usability of the tools, the System Usability Scale will be administered (UTAUT) Acceptance of tools: to assess patients' acceptance of the tools the Unified Theory of Acceptance and Use of Technology will be used (UTAUT) Willingness to pay: Because th emonetary value of the tools is a significant factor for patients using the tools, we will assess patients' willingness to pay. For this purpose one part of the UTAUT will be used (Price Value). In addition, patients will be asked to list the price they would be willing to pay for the product. Satisfaction with the intervention; usability and acceptance, and willingness to pay will qualitatively be assessed and with the above mentioned questionnaires. Cost effectiveness: To assess the cost-effectiveness of the intervention the EQ-5D questionnaire will be assessed. Health care consumption: Health care consumption will be assessed by purpose designed questions. OTHER PARAMETERS Depression: The Patient Health Questionnaire (PHQ-9) will be sued to assess depression within the sample. Anxiety: The Generalized Anxiety Disoder (GAD-7) questionnaire will be used to assess the levels of anxiety. Type D Personality: In order to assess whether the patients have a Type D (distressed) personality (tendency to experience negative affect; while at the same time being socially inhibited from sharing these feelings with others), the DS14 questionnaire will be administered.

Countries

Netherlands, Spain, Taiwan (Province of China)

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)