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

Implantable Defibrillator User Clinical Trial

— ACQUIRE-ICD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02976961
• Other study ID #: 31779
• Status: Completed
• Phase: N/A
• Start date: February 6, 2017
• Est. completion date: May 8, 2023

Study information

• Verified date: May 2023
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Distress
• Implantable Defibrillator User

Intervention

Other:
• Supportive care
Information, guidance, supportive care, and psychological intervention

Locations

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

Sponsors (6)

Lead Sponsor	Collaborator
Susanne Schmidt Pedersen	Aalborg University Hospital, Aarhus University Hospital, Odense University Hospital, University Hospital, Gentofte, Copenhagen, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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