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Completed

NCT Number: NCT02976961

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

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.

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Key information

Conditions

Implantable Defibrillator User Behavior Distress Empowerment Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gentofte Hospital, Gentofte Municipality, Hellerup, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supportive Care

Other

Information, guidance, supportive care, and psychological intervention

Primary outcomes

  1. Device acceptance

    Time frame: 12 months

    Measured with the Florida Patient Acceptance Survey (FPAS)

Secondary outcomes

  1. Health status (generic)

    Time frame: 12 and 24 months

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

  2. Patient empowerment (ICD-EMPOWER)

    Time frame: 12 and 24 months

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

  3. ICD patient concerns (ICDC)

    Time frame: 12 and 24 months

    8-item ICD Patients' Concern questionnaire that taps into fear of shock as reported by the patient

  4. Symptoms of anxiety

    Time frame: 12 and 24 months

    Generalized Anxiety Disorder scale (GAD-7)

  5. Symptoms of depression

    Time frame: 12 and 24 months

    Patient Health Questionnaire (PHQ-9)

  6. Health status (heart failure specific)

    Time frame: 12 and 24 months

    Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

  7. Return to work

    Time frame: 12 and 24 months

    Purpose-designed questions

  8. Time to first ICD therapy

    Time frame: 12 and 24 months

    Defined as ATP, cardioversion or shock

  9. Time to first hospitalization due to a cardiac cause

    Time frame: 12 and 24 months

    Hospitalization due to a cardiac cause

  10. Time to mortality

    Time frame: 12 and 24 months

    Mortality

  11. Cost-effectiveness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Susanne Schmidt Pedersen

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Odense University Hospital
  • University Hospital, Gentofte, Copenhagen
  • Zealand University Hospital

Registry information

Official study 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

Acronym: ACQUIRE-ICD

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Nov 30, 2016
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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