Implantable Defibrillator User Clinical Trial
— ACQUIRE-ICDOfficial title:
A Personalized and Interactive Web-based Health Care Innovation to AdvanCe the QualIty of Life and caRE of Patients With an Implantable Cardioverter Defibrillator
NCT number | NCT02976961 |
Other study ID # | 31779 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 6, 2017 |
Est. completion date | May 8, 2023 |
Verified date | May 2023 |
Source | University of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 478 |
Est. completion date | May 8, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University Hospital | Aalborg | |
Denmark | Aarhus University Hospital | Aarhus | |
Denmark | Gentofte Hospital | Gentofte | Hellerup |
Denmark | Odense University Hospital | Odense | |
Denmark | Zealand University Hospital - Roskilde | Roskilde |
Lead Sponsor | Collaborator |
---|---|
Susanne Schmidt Pedersen | Aalborg University Hospital, Aarhus University Hospital, Odense University Hospital, University Hospital, Gentofte, Copenhagen, Zealand University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Device acceptance | Measured with the Florida Patient Acceptance Survey (FPAS) | 12 months | |
Secondary | Health status (generic) | Measured with the Short Form Health Survey 12 items (SF-12) | 12 and 24 months | |
Secondary | Patient empowerment (ICD-EMPOWER) | Purpose-designed and disease-specific 14-item measure that measures patient empowerment | 12 and 24 months | |
Secondary | 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 | |
Secondary | Symptoms of anxiety | Generalized Anxiety Disorder scale (GAD-7) | 12 and 24 months | |
Secondary | Symptoms of depression | Patient Health Questionnaire (PHQ-9) | 12 and 24 months | |
Secondary | Health status (heart failure specific) | Kansas City Cardiomyopathy Questionnaire (KCCQ-12) | 12 and 24 months | |
Secondary | Return to work | Purpose-designed questions | 12 and 24 months | |
Secondary | Time to first ICD therapy | Defined as ATP, cardioversion or shock | 12 and 24 months | |
Secondary | Time to first hospitalization due to a cardiac cause | Hospitalization due to a cardiac cause | 12 and 24 months | |
Secondary | Time to mortality | Mortality | 12 and 24 months | |
Secondary | 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 |
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