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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Aarhus University Hospital | OTHER |
| Aalborg University Hospital | OTHER |
| University Hospital, Gentofte, Copenhagen |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 |
|
| Usual care | No Intervention | Implantable cardioverter defibrillator implant + usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supportive care | Other | Information, guidance, supportive care, and psychological intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device acceptance | Measured with the Florida Patient Acceptance Survey (FPAS) | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne S Pedersen, PhD | University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gentofte Hospital | Gentofte Municipality | Hellerup | 2900 | Denmark | ||
| Aalborg University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29969990 | Derived | Pedersen SS, Skovbakke SJ, Wiil UK, Schmidt T, dePont Christensen R, Brandt CJ, Sorensen J, Vinther M, Larroude CE, Melchior TM, Riahi S, Smolderen KGE, Spertus JA, Johansen JB, Nielsen JC. Effectiveness of a comprehensive interactive eHealth intervention on patient-reported and clinical outcomes in patients with an implantable cardioverter defibrillator [ACQUIRE-ICD trial]: study protocol of a national Danish randomised controlled trial. BMC Cardiovasc Disord. 2018 Jul 3;18(1):136. doi: 10.1186/s12872-018-0872-7. |
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| ID | Term |
|---|---|
| D000079102 | Empowerment |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| OTHER |
| Zealand University Hospital | OTHER |
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| 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 |
| Aalborg |
| 9100 |
| Denmark |
| Aarhus University Hospital | Aarhus | 8000 | Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |
| Zealand University Hospital - Roskilde | Roskilde | 4000 | Denmark |