Short summary

ACQUIRE-ICD will develop (using a user-centered design) and evaluate the clinical efficacy and cost-effectiveness of a personalized, interactive and integrated web-based care innovation, in a randomized controlled trial design. Patients with a first-time implantable cardioverter defibrillator (ICD) will be recruited from several hospitals in Denmark at the time of implant and followed up for 2 years on patient-reported outcomes and long-term morbidity and mortality. This study will be able to show for the very first time the effect of an individually targeted intervention offered via a digital platform that uses asynchronous feedback and guidance with information about the ICD, quizzes to engage and educate patients, and tools to overcome barriers also of a psychosocial nature.

Rationale

There has been a shift in the management and care of patients with an implantable cardioverter defibrillator (ICD), with the majority of patients being on remote monitoring as a replacement for face-to-face in-clinic visits. Despite its clear advantages in terms of efficiency, timely intervention and overall saved cost, the widespread implementation of remote monitoring may create missed opportunities for ICD patients and their relatives to ask health care professionals questions and to voice their concerns about their device and treatment. Remote monitoring may also limit opportunities for health care professionals to spot vulnerable patients and to provide the information, care, and support that help facilitate patients' transition and adaptation to living successfully with their device and their heart disease. We will evaluate the clinical efficacy and cost-effectiveness of a personalized, interactive and integrated web-based care innovation, using a randomized controlled trial design. The care innovation will encourage patients to become co-managers of their own disease and enable patients to routinely monitor and flag changes in their symptoms and quality of life. In case of aggravation of symptoms, timely and adequate intervention can be initiated, with treatment targeted to the individual needs and preferences of patients and determined in a shared decision-making process between patients and hospital staff. The overarching objective of ACQUIRE-ICD is to empower patients with an ICD to live a better life with their device and their heart disease using patient-centered tools.

Description of the cohort

Consecutively enrolled patients implanted with a first-time implantable cardioverter defibrillator (ICD) or ICD with cardiac resynchronization therapy (CRT-D) and at least 18 years of age are recruited from Odense University Hospital, Aarhus University Hospital, or Aalborg University Hospital. Patients need to be able to manage and cope with computer technology and to have sufficient knowledge of the Danish language to participate.

Data and biological material

Information will be captured on patients' demographic (e.g. gender, age, education, etc.) and clinical (e.g. cardiac history, comorbidities, medication, etc.) and psychological profile and on patient-reported outcomes (e.g. quality of life). This information will either be captured via patients' electronic health records, purspose-designed questions on standardized and validated questionnaires. Information will also be gathered on hospital readmissions, health-care consumption etc. in order to be able to evaluate the cost-effectiveness of the intervention. 

Collaborating researchers and departments

Department of Psychology, University of Southern Denmark

Department of Cardiology, Odense University Hospital

• Professor Susanne S. Pedersen

The Maersk McKinney Moller Institute, University of Southern Denmark

• Professor Uffe Kock Wiil

Centre of Health Economics Research, University of Southern Denmark

• Professor Jan Sørensen

Research Unit of General Practice, University of Southern Denmark

• Statistician Rene dePont Christensen
• PhD-student Carl Brandt

Department of Cardiology, Odense University Hospital

• Dr. Jens Brock Johansen

Department of Cardiology, Aarhus University Hospital

• Professor Jens Cosedis Nielsen

Department of Cardiology, Aalborg University Hospital

• Dr. Sam Riahi

School of Medicine, Mid-America Heart Institute, Kansas City, USA

• Dr. John Spertus
• Dr. Kim Smolderen

Publications associated with the project

Nørgaard B, Sandvei M, Rottmann N, Johannessen H, Wiil UK, Schmidt UK, Pedersen SS (2017). Development of (a Danish) web-based care innovation for patients with heart disease. Lessons learnt from a participatory design study. Journal of Medical Internet Research - Research Protocols, 6(5):e75.

Pedersen SS, Schmidt T, Skovbakke SJ, Wiil UK, Egstrup K, Smolderen KGE, Spertus J (2017). A personalized and interactive web-based health care innovation to AdvanCe the QualIty of life and caRE of patients with heart failure (ACQUIRE-HF): A mixed-methods feasibility study. Journal of Medical Internet Research - Research Protocols, 6(5):e96.

Pedersen SS, Skovbakke SJ, Wiil UK, Schmidt T, Christensen RD, Brandt CJ, Sørensen J, Vinther M, Larroudé CE, Melchior TM, Riahi S, Smolderen KGE, Spertus JA, Johansen JB, Nielsen JC (2018). 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 randomized controlled trial. BMC Cardiovascular Disorders, 18(1):136.