A Personalized and Interactive Web-based Health Care Innovation to Advance the Quality of Care (ACQUIRE-ICD)

Susanne Schmidt Pedersen

Status: Completed

Conditions: Distress; Implantable Defibrillator User

Treatments: Other: Supportive care

Study type: Interventional

Funder types: Other

Identifiers

NCT02976961

31779

Details and patient eligibility

About

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.

Enrollment: 478 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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478 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Other: Supportive care

Usual care

No Intervention group

Description:

Implantable cardioverter defibrillator implant + usual care