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

Susanne Schmidt Pedersen478 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

478

Conditions

Implantable Defibrillator User Distress

Interventions

Supportive careOTHER

Information, guidance, supportive care, and psychological intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Gentofte Hospital

Gentofte Municipality, Hellerup, Denmark

Aalborg University Hospital

Aalborg, Denmark

Aarhus University Hospital

Aarhus, Denmark

Odense University Hospital

Odense, Denmark

Outcomes

Primary Outcomes

Device acceptance

Measured with the Florida Patient Acceptance Survey (FPAS)

Time frame: 12 months

Secondary Outcomes

Health status (generic)

Measured with the Short Form Health Survey 12 items (SF-12)

Time frame: 12 and 24 months

Patient empowerment (ICD-EMPOWER)

Purpose-designed and disease-specific 14-item measure that measures patient empowerment

Time frame: 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

Time frame: 12 and 24 months

Symptoms of anxiety

Generalized Anxiety Disorder scale (GAD-7)

Time frame: 12 and 24 months

Symptoms of depression

Patient Health Questionnaire (PHQ-9)

Time frame: 12 and 24 months

Health status (heart failure specific)

Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

Time frame: 12 and 24 months

Return to work

Purpose-designed questions

Time frame: 12 and 24 months

Time to first ICD therapy

Defined as ATP, cardioversion or shock

Data from ClinicalTrials.gov

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