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Patients’ experiences of clinical trial participation involving a product remotely assessing study drug adherence

Henriksson, Catrin ; Olsson, Anneli LU orcid ; Andersen, Kasper LU orcid ; Arefalk, Gabriel ; Erlinge, David LU orcid ; Hofmann, Robin ; Ridderstråle, Wilhelm ; Rutgersson, Annika ; Oldgren, Jonas and James, Stefan (2024) In Contemporary Clinical Trials Communications 40.
Abstract

Background: The participation of patients in clinical trials is crucial for the development of healthcare. There are several challenges in the recruitment of trial participants with acute medical conditions. The registry-based randomized DAPA-MI clinical trial recruited patients during hospitalization for myocardial infarction and provided study drugs in bottles with smart caps that used wireless technology to transmit monitoring data. This interview study aimed to investigate patients’ experience of participation in a clinical trial and their attitude to the new bottle cap technology. Methods: A subset of patients participating in the DAPA-MI trial were recruited from four hospitals in Sweden. Semi-structured interviews were conducted... (More)

Background: The participation of patients in clinical trials is crucial for the development of healthcare. There are several challenges in the recruitment of trial participants with acute medical conditions. The registry-based randomized DAPA-MI clinical trial recruited patients during hospitalization for myocardial infarction and provided study drugs in bottles with smart caps that used wireless technology to transmit monitoring data. This interview study aimed to investigate patients’ experience of participation in a clinical trial and their attitude to the new bottle cap technology. Methods: A subset of patients participating in the DAPA-MI trial were recruited from four hospitals in Sweden. Semi-structured interviews were conducted and analysed using manifest content analysis. Results: Video interviews were performed including 21 patients (four women and 17 men). The median age was 59 years (range 44–80). Four categories of patients' experiences were identified. A willingness to contribute consisted of patients’ positive attitudes to participation and to be a part of development and research. The perception of information emphasized the value of the oral information as well as the importance of time for reflection. Be in a vulnerable condition highlighted the impaired ability to perceive and remember in the acute medical condition. Adaptation to a new technology described the overall positive experiences of the smart bottle cap to evaluate adherence. Conclusions: Patients’ experiences of trial participation were in general positive but some challenges in the acute setting of a myocardial infarction were revealed. The smart bottle cap was well accepted, despite some handling difficulties.

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author
; ; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Medical technology, Myocardial infarction, Patient experience, Trial participation
in
Contemporary Clinical Trials Communications
volume
40
article number
101307
publisher
Elsevier
external identifiers
  • scopus:85195298513
  • pmid:38947982
ISSN
2451-8654
DOI
10.1016/j.conctc.2024.101307
language
English
LU publication?
yes
id
c4d15c59-2078-4a33-a364-9c48e5a4c7fd
date added to LUP
2024-07-02 13:51:46
date last changed
2024-07-03 03:00:02
@article{c4d15c59-2078-4a33-a364-9c48e5a4c7fd,
  abstract     = {{<p>Background: The participation of patients in clinical trials is crucial for the development of healthcare. There are several challenges in the recruitment of trial participants with acute medical conditions. The registry-based randomized DAPA-MI clinical trial recruited patients during hospitalization for myocardial infarction and provided study drugs in bottles with smart caps that used wireless technology to transmit monitoring data. This interview study aimed to investigate patients’ experience of participation in a clinical trial and their attitude to the new bottle cap technology. Methods: A subset of patients participating in the DAPA-MI trial were recruited from four hospitals in Sweden. Semi-structured interviews were conducted and analysed using manifest content analysis. Results: Video interviews were performed including 21 patients (four women and 17 men). The median age was 59 years (range 44–80). Four categories of patients' experiences were identified. A willingness to contribute consisted of patients’ positive attitudes to participation and to be a part of development and research. The perception of information emphasized the value of the oral information as well as the importance of time for reflection. Be in a vulnerable condition highlighted the impaired ability to perceive and remember in the acute medical condition. Adaptation to a new technology described the overall positive experiences of the smart bottle cap to evaluate adherence. Conclusions: Patients’ experiences of trial participation were in general positive but some challenges in the acute setting of a myocardial infarction were revealed. The smart bottle cap was well accepted, despite some handling difficulties.</p>}},
  author       = {{Henriksson, Catrin and Olsson, Anneli and Andersen, Kasper and Arefalk, Gabriel and Erlinge, David and Hofmann, Robin and Ridderstråle, Wilhelm and Rutgersson, Annika and Oldgren, Jonas and James, Stefan}},
  issn         = {{2451-8654}},
  keywords     = {{Medical technology; Myocardial infarction; Patient experience; Trial participation}},
  language     = {{eng}},
  publisher    = {{Elsevier}},
  series       = {{Contemporary Clinical Trials Communications}},
  title        = {{Patients’ experiences of clinical trial participation involving a product remotely assessing study drug adherence}},
  url          = {{http://dx.doi.org/10.1016/j.conctc.2024.101307}},
  doi          = {{10.1016/j.conctc.2024.101307}},
  volume       = {{40}},
  year         = {{2024}},
}