Clinical trial NCT02976961: A Personalized and Interactive Web-based Health Care Innovation to Advance the Quality of Care
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implantable Defibrillator User
Distress
Keywords: Information
Empowerment
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Aarhus University Hospital
name: Aalborg University Hospital
name: University Hospital, Gentofte, Copenhagen
name: Zealand University Hospital
First posted: 2016-11-30
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Device acceptance
timeFrame: 12 months
Secondary outcomes:
measure: Health status (generic)
timeFrame: 12 and 24 months
measure: Patient empowerment (ICD-EMPOWER)
timeFrame: 12 and 24 months
measure: ICD patient concerns (ICDC)
timeFrame: 12 and 24 months
measure: Symptoms of anxiety
timeFrame: 12 and 24 months
measure: Symptoms of depression
timeFrame: 12 and 24 months
measure: Health status (heart failure specific)
timeFrame: 12 and 24 months
measure: Return to work
timeFrame: 12 and 24 months
measure: Time to first ICD therapy
timeFrame: 12 and 24 months
measure: Time to first hospitalization due to a cardiac cause
timeFrame: 12 and 24 months
measure: Time to mortality
timeFrame: 12 and 24 months
measure: Cost-effectiveness
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Gentofte Hospital
state: Hellerup
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital - Roskilde
Study officials:
affiliation: University of Southern Denmark
name: Susanne S Pedersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.