Distress, Implantable Defibrillator User
Conditions
Keywords
Information, Empowerment
Brief summary
This study evaluates the clinical efficacy and cost-effectiveness of the ACQUIRE-ICD care innovation as add-on to usual care as compared to usual care alone in patients with an implantable cardioverter defibrillator.
Interventions
OTHERSupportive care
Information, guidance, supportive care, and psychological intervention
Sponsors
Odense University Hospital
Aarhus University Hospital
Aalborg University Hospital
University Hospital, Gentofte, Copenhagen
Zealand University Hospital
Susanne Schmidt Pedersen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a first-time ICD or CRT-D * ≥18 years of age
Exclusion criteria
* Subcutaneous ICD * Upgrade from a pacemaker to ICD or CRT * History of psychiatric illness other than affective/anxiety disorders * Cognitive impairments (e.g. dementia) * Left ventricular assist device (LVAD) or upcoming LVAD implant * Under evaluation or on the waiting list for heart transplantation * No e-mail address * Inability to manage or cope with computer technology * Insufficient knowledge of the Danish language * Participation in other randomized controlled trials unless of a technical nature * Irresponsible to ask patient to participate according to GCP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device acceptance | 12 months | Measured with the Florida Patient Acceptance Survey (FPAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of depression | 12 and 24 months | Patient Health Questionnaire (PHQ-9) |
| Health status (heart failure specific) | 12 and 24 months | Kansas City Cardiomyopathy Questionnaire (KCCQ-12) |
| Return to work | 12 and 24 months | Purpose-designed questions |
| Time to first ICD therapy | 12 and 24 months | Defined as ATP, cardioversion or shock |
| Time to first hospitalization due to a cardiac cause | 12 and 24 months | Hospitalization due to a cardiac cause |
| Symptoms of anxiety | 12 and 24 months | Generalized Anxiety Disorder scale (GAD-7) |
| Patient empowerment (ICD-EMPOWER) | 12 and 24 months | Purpose-designed and disease-specific 14-item measure that measures patient empowerment |
| ICD patient concerns (ICDC) | 12 and 24 months | 8-item ICD Patients' Concern questionnaire that taps into fear of shock as reported by the patient |
| Health status (generic) | 12 and 24 months | Measured with the Short Form Health Survey 12 items (SF-12) |
| Cost-effectiveness | 12 and 24 months | Incremental cost gained per quality adjusted life year (QALY) and burden on health care professionals (physicians and nurses)). This will be measured with the EQ-5D-5L or captured from the patient's electronic health record (EHR; e.g. number of phone calls, emails, and consultations with patients), and purpose-designed questions. |
| Time to mortality | 12 and 24 months | Mortality |
Countries
Denmark
Outcome results
None listed