Article Text

Download PDFPDF

Protocol
Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE)
  1. Matilda Cederberg1,2,
  2. Lilas Ali1,2,3,
  3. Inger Ekman1,2,4,
  4. Kristina Glise5,
  5. Ingibjörg H Jonsdottir5,6,
  6. Hanna Gyllensten1,2,
  7. Karl Swedberg1,2,7,
  8. Andreas Fors1,2,8
  1. 1Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
  2. 2Centre for Person-Centred Care (GPCC), University of Gothenburg, Gothenburg, Sweden
  3. 3Psychiatric department, Sahlgrenska University Hospital, Gothenburg, Sweden
  4. 4Department of Internal Medicine and Geriatrics, Sahlgrenska University Hospital Östra, Gothenburg, Sweden
  5. 5The Institute of Stress Medicine, Region Västra Götaland, Gothenburg, Sweden
  6. 6School of Public Health and Community Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden
  7. 7Department of Molecular and Clinical Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
  8. 8Research and Development, Primary Health Care, Region Västra Götaland, Gothenburg, Sweden
  1. Correspondence to Matilda Cederberg; matilda.cederberg{at}gu.se

Abstract

Introduction The number of people dealing with common mental disorders (CMDs) is a major concern in many countries, including Sweden. Sickness absence resulting from CMDs is often long-lasting and advancing return to work is a complex process impacted by several factors, among which self-efficacy appears to be an important personal resource. Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patients with CMDs and in an eHealth context.

Methods and analysis This study is an open randomised controlled trial comparing a control group receiving standard care with an intervention group receiving standard care plus PCC by telephone and a digital platform. The primary outcome measure is a composite score of changes in sick leave and self-efficacy. Participants will include 220 primary care patients on sick leave due to CMDs and data will mainly be collected through questionnaires at baseline and 3, 6, 12 and 24 months from the inclusion date. Inclusion is ongoing and expected to be completed during the fall of 2020. A process and health economic evaluation will also be conducted.

Ethics and dissemination This study was approved by the Regional Ethical Review Board in Gothenburg, Sweden. Results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. This project is part of a broader research programme conducted at the Gothenburg Centre for Person-Centred Care (GPCC), where extensive work is undertaken to disseminate knowledge on and implementation of PCC.

Trial registration number NCT03404583.

  • mental health
  • primary care
  • public health
  • information technology
  • quality in health care
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

Statistics from Altmetric.com

Footnotes

  • Contributors All authors were involved in the design of the study. MC drafted the manuscript with critical input from LA, IE, KG, IHJ, HG, KS and AF. AF is the principal investigator and grant holder of the investigation. All authors reviewed, edited and approved the final version of the manuscript.

  • Funding This work was supported by The Swedish Research Council for Health, Working Life and Welfare (reference number 2016-07418, 2017-00557 and 2019-01726). The study was financed by grants from the Swedish state under the agreement between the Swedish government and the country councils, the ALF agreement (ALFGBG-772191 and ALFGBG-932659).

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the 'Methods' section for further details.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.