A Personalized and Interactive Web-based Health Care Innovation to Advance the Quality of Care

Study Overview
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Brief Summary
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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.

Official Title
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A Personalized and Interactive Web-based Health Care Innovation to AdvanCe the QualIty of Life and caRE of Patients With an Implantable Cardioverter Defibrillator

Conditions
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Implantable Defibrillator User, Distress

Intervention / Treatment
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* Other: Supportive care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Implantable cardioverter defibrillator implant + usual care + supportive care given via an e-health platform. The supportive care consists of information, dialogue with a nurse or psychologist, CBT-based psychological intervention online, quizzes to increase knowledge | Other: Supportive care<br>* Information, guidance, supportive care, and psychological intervention<br>|
| No Intervention: Usual care<br>Implantable cardioverter defibrillator implant + usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device acceptance | Measured with the Florida Patient Acceptance Survey (FPAS) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health status (generic) | Measured with the Short Form Health Survey 12 items (SF-12) | 12 and 24 months | 
| Patient empowerment (ICD-EMPOWER) | Purpose-designed and disease-specific 14-item measure that measures patient empowerment | 12 and 24 months | 
| ICD patient concerns (ICDC) | 8-item ICD Patients' Concern questionnaire that taps into fear of shock as reported by the patient | 12 and 24 months | 
| Symptoms of anxiety | Generalized Anxiety Disorder scale (GAD-7) | 12 and 24 months | 
| Symptoms of depression | Patient Health Questionnaire (PHQ-9) | 12 and 24 months | 
| Health status (heart failure specific) | Kansas City Cardiomyopathy Questionnaire (KCCQ-12) | 12 and 24 months | 
| Return to work | Purpose-designed questions | 12 and 24 months | 
| Time to first ICD therapy | Defined as ATP, cardioversion or shock | 12 and 24 months | 
| Time to first hospitalization due to a cardiac cause | Hospitalization due to a cardiac cause | 12 and 24 months | 
| Time to mortality | Mortality | 12 and 24 months | 
| Cost-effectiveness | 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. | 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Information, Empowerment