A Personalized and Interactive Web-based Health Care Innovation to Advance the Quality of Care
NCT ID: NCT02976961
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
478 participants
INTERVENTIONAL
2017-02-06
2023-05-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
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
Supportive care
Information, guidance, supportive care, and psychological intervention
Usual care
Implantable cardioverter defibrillator implant + usual care
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Supportive care
Information, guidance, supportive care, and psychological intervention
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ≥18 years of age
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Odense University Hospital
OTHER
Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
University Hospital, Gentofte, Copenhagen
OTHER
Zealand University Hospital
OTHER
Susanne Schmidt Pedersen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Susanne Schmidt Pedersen
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Susanne S Pedersen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gentofte Hospital
Gentofte Municipality, Hellerup, Denmark
Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Odense University Hospital
Odense, , Denmark
Zealand University Hospital - Roskilde
Roskilde, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pedersen SS, Skovbakke SJ, Wiil UK, Schmidt T, dePont Christensen R, Brandt CJ, Sorensen J, Vinther M, Larroude CE, Melchior TM, Riahi S, Smolderen KGE, Spertus JA, Johansen JB, Nielsen JC. Effectiveness of a comprehensive interactive eHealth intervention on patient-reported and clinical outcomes in patients with an implantable cardioverter defibrillator [ACQUIRE-ICD trial]: study protocol of a national Danish randomised controlled trial. BMC Cardiovasc Disord. 2018 Jul 3;18(1):136. doi: 10.1186/s12872-018-0872-7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
31779
Identifier Type: -
Identifier Source: org_study_id