cardiac disease
Conditions
Interventions
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 and
Sponsors
Badalona Serveis Assisstencials
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: age 18-75 years, newly 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 sufficient knowledge on using personal computer or smartphone), and have sufficient knowledge of the countries* native language. Additional inclusion criteria for HF patients only is to have a left ejection fraction of *35% and experience HF symptoms (e.g. shortness of breath, chest pain, exhaustion)
Exclusion criteria
Exclusion criteria: significant cognitive impairments (e.g. dementia), patients who are on the waiting list for heart transplantation, life expectancy
Design outcomes
Primary
| Measure | Time 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 program) has occurred will be assessed using purpose designed questions by the Do Something Different program. Quality of life: Changes in quality of life will be assessed using the EuroQol-5D questionnaire. As this is a widely used instrument it will allow us to integrate data from different partners. | — |
Secondary
| Measure | Time 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) (59). Willingness to pay: Because the monetary 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. 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 use to assess depression within the sample. Anxiety: The Generalized Anxiety Disorder (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
Outcome results
None listed