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Efficacy and cost-effectiveness of a therapist-assisted web-based intervention for depression and anxiety in patients with ischemic heart disease attending cardiac rehabilitation [eMindYourHeart trial]: a randomised controlled trial protocol

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  • Susanne S. Pedersen, Syddansk Universitet, Odense Patient Data Explorative Network (OPEN)
  • ,
  • Christina M. Andersen, Syddansk Universitet
  • ,
  • Robert Ahm, Syddansk Universitet
  • ,
  • Søren J. Skovbakke, Syddansk Universitet
  • ,
  • Robin Kok, Syddansk Universitet
  • ,
  • Charlotte Helmark, Sjællands Universitetshospital
  • ,
  • Uffe K. Wiil, Syddansk Universitet
  • ,
  • Thomas Schmidt, Syddansk Universitet
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  • Kim Rose Olsen, Syddansk Universitet
  • ,
  • Jacob Hjelmborg, Syddansk Universitet
  • ,
  • Ann Dorthe Zwisler, Syddansk Universitet
  • ,
  • Lisbeth Frostholm

Background: One in five patients with ischaemic heart disease (IHD) develop comorbid depression or anxiety. Depression is associated with risk of non-adherence to cardiac rehabilitation (CR) and dropout, inadequate risk factor management, poor quality of life (QoL), increased healthcare costs and premature death. In 2020, IHD and depression are expected to be among the top contributors to the disease-burden worldwide. Hence, it is paramount to treat both the underlying somatic disease as well as depression and anxiety. eMindYourHeart will evaluate the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention targeting depression and anxiety in patients with IHD, which may help fill this gap in clinical care. Methods: eMindYourHeart is a multi-center, two-armed, unblinded randomised controlled trial that will compare a therapist-assisted eHealth intervention to treatment as usual in 188 CR patients with IHD and comorbid depression or anxiety. The primary outcome of the trial is symptoms of depression, measured with the Hospital Anxiety and Depression Scale (HADS) at 3 months. Secondary outcomes evaluated at 3, 6, and 12 months include symptoms of depression and anxiety (HADS), perceived stress, health complaints, QoL (HeartQoL), trial dropout (number of patients dropped out in either arm at 3 months) and cost-effectiveness. Discussion: To our knowledge, this is the first trial to evaluate both the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention in patients with IHD and comorbid psychological distress as part of CR. Integrating screening for and treatment of depression and anxiety into standard CR may decrease dropout and facilitate better risk factor management, as it is presented as “one package” to patients, and they can access the eMindYourHeart program in their own time and at their own convenience. The trial holds a strong potential for improving the quality of care for an increasing population of patients with IHD and comorbid depression, anxiety or both, with likely benefits to patients, families, and society at large due to potential reductions in direct and indirect costs, if proven successful. Trial registration The trial was prospectively registered on https://clinicaltrials.gov/ct2/show/NCT04172974 on November 21, 2019 with registration number [NCT04172974].

TidsskriftBMC Cardiovascular Disorders
StatusUdgivet - jan. 2021

Bibliografisk note

Funding Information:
This trial was supported with a grant from SDU’s Strategic funding (DKK 499,000), the Danish Heart Foundation (grant 18-R124-A8309–22106 – DKK 1 million), Region of Southern Denmark and Region of Zealand joint research foundation (Grant # A343 – DKK 270,000), Odense University Hospital Research Foundation (Grant # 72-A3575 - DKK 300,000 and Grant # 2021-A4420 - DKK 299,000) and “Sygesikring danmark” (Grant # 2020-0041 - DKK 5,000,000). None of the funding agencies have had any role in the design of the study and will have no role in collection, analysis, and interpretation of data and in writing the manuscript.

Publisher Copyright:
© 2021, The Author(s).

Copyright 2020 Elsevier B.V., All rights reserved.

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