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

Not Applicable

Completed

• Conditions: Distress; Implantable Defibrillator User
• Interventions: Other: Supportive care

• Registration Number: NCT02976961
• Lead Sponsor: Susanne Schmidt Pedersen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-11-30
• Study Start: 2017-02-06
• Primary Completion: 2022-12-31
• Study Completion: 2023-05-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 478

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Supportive care	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

Primary Outcome Measures

Name	Time	Method
Device acceptance	12 months	Measured with the Florida Patient Acceptance Survey (FPAS)

Secondary Outcome Measures

Name	Time	Method
Time to mortality	12 and 24 months	Mortality
Health status (generic)	12 and 24 months	Measured with the Short Form Health Survey 12 items (SF-12)
ICD patient concerns (ICDC)	12 and 24 months	8-item ICD Patients' Concern questionnaire that taps into fear of shock as reported by the patient
Symptoms of depression	12 and 24 months	Patient Health Questionnaire (PHQ-9)
Health status (heart failure specific)	12 and 24 months	Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Return to work	12 and 24 months	Purpose-designed questions
Time to first hospitalization due to a cardiac cause	12 and 24 months	Hospitalization due to a cardiac cause
Symptoms of anxiety	12 and 24 months	Generalized Anxiety Disorder scale (GAD-7)
Patient empowerment (ICD-EMPOWER)	12 and 24 months	Purpose-designed and disease-specific 14-item measure that measures patient empowerment
Time to first ICD therapy	12 and 24 months	Defined as ATP, cardioversion or shock
Cost-effectiveness	12 and 24 months	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.

Trial Locations

Locations (5)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Gentofte Hospital; 🇩🇰 Gentofte, Hellerup, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Zealand University Hospital - Roskilde; 🇩🇰 Roskilde, Denmark