Effectiveness and cost-effectiveness of an integrated digital psychological intervention (EmoEase) in Chinese chronic obstructive pulmonary disease patients: Study protocol of a randomized controlled trial

Simiao Chen^{1

2}, Wenjin Chen^{1

2}, Yanfei Li², Yiwen Yu¹, Qiushi Chen³, Lirui Jiao⁴, Ke Huang⁵, Xunliang Tong⁶, Pascal Geldsetzer^{7

8}, Aditi Bunker², Xingyuan Fang⁹, Shu Jing¹, Yuhao Liu¹, Yanming Li⁶, Liu He¹, Chao Wang¹, Weiyu Wang¹⁰, Zhoutao Zheng¹, Shiyu Zhang¹, Jinghan Zhao¹, Ting Yang⁵, Till Bärnighausen^{2

8}, Chen Wang¹

Affiliations

¹ Chinese Academy of Medical Sciences & Peking Union Medical College, School of Population Medicine and Public Health, Beijing, China.
² Faculty of Medicine and University Hospital, Heidelberg Institute of Global Health (HIGH), Heidelberg University, Heidelberg, Germany.
³ The Harold and Inge Marcus Department of Industrial and Manufacturing Engineering, The Pennsylvania State University, University Park, PA, USA.
⁴ Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁵ National Center for Respiratory Medicine, State Key Laboratory of Respiratory Health and Multimorbidity, National Clinical Research Center for Respiratory Diseases, Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China.
⁶ Department of Pulmonary and Critical Care Medicine, National Center of Gerontology, Beijing Hospital, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.
⁷ Department of Medicine, Stanford University, Stanford, CA, USA.
⁸ Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
⁹ Department of Biostatistics and Bioinformatics, The Duke University, Durham, NC, USA.
¹⁰ Office of Student Affairs, Lanzhou Institute of Technology, Lanzhou, China.

PMID: 39381816
PMCID: PMC11459470
DOI: 10.1177/20552076241277650

Effectiveness and cost-effectiveness of an integrated digital psychological intervention (EmoEase) in Chinese chronic obstructive pulmonary disease patients: Study protocol of a randomized controlled trial

Simiao Chen et al. Digit Health. 2024.

. 2024 Oct 1:10:20552076241277650.

doi: 10.1177/20552076241277650. eCollection 2024 Jan-Dec.

Authors

Affiliations

¹ Chinese Academy of Medical Sciences & Peking Union Medical College, School of Population Medicine and Public Health, Beijing, China.
² Faculty of Medicine and University Hospital, Heidelberg Institute of Global Health (HIGH), Heidelberg University, Heidelberg, Germany.
³ The Harold and Inge Marcus Department of Industrial and Manufacturing Engineering, The Pennsylvania State University, University Park, PA, USA.
⁴ Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁵ National Center for Respiratory Medicine, State Key Laboratory of Respiratory Health and Multimorbidity, National Clinical Research Center for Respiratory Diseases, Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China.
⁶ Department of Pulmonary and Critical Care Medicine, National Center of Gerontology, Beijing Hospital, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.
⁷ Department of Medicine, Stanford University, Stanford, CA, USA.
⁸ Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
⁹ Department of Biostatistics and Bioinformatics, The Duke University, Durham, NC, USA.
¹⁰ Office of Student Affairs, Lanzhou Institute of Technology, Lanzhou, China.

PMID: 39381816
PMCID: PMC11459470
DOI: 10.1177/20552076241277650

Abstract

Background: Mental health problems in patients with chronic obstructive pulmonary disease (COPD) are common and frequently neglected. Digital psychological interventions may reduce mental health problems, but their effectiveness has not been evaluated in the Chinese COPD population. In this study, we will develop an integrated digital psychological intervention (EmoEase) and evaluate its effectiveness and cost-effectiveness in enhancing the mental wellbeing of patients with COPD in China.

Methods: This study is a multicenter, two-arm, randomized controlled trial (RCT) with a parallel-group design to enroll at least 420 patients with COPD with age over 35 years. Participants will be assigned to receive either usual care (control group) or usual care + EmoEase (intervention group). Assessments will take place at baseline (T0) and 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline, and participants will be asked to complete questionnaires and physical measurements. The primary outcome measure will assess mental wellbeing using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcome measures will assess mental health, physical health, COPD symptoms, health risk behaviors, socioeconomic indicators, and healthcare utilization and expenditure. Analyses will utilize an intention-to-treat approach.

Discussion: This is the first RCT to examine the value of EmoEase, a novel digital psychological intervention for patients with COPD. If this intervention is effective and cost-effective, it could be rapidly scaled up to provide mental healthcare for patients with COPD in China.

Trial registration: ClinicalTrials.gov Identifier: NCT06026709. Date of first submission: 30 August 2023. https://clinicaltrials.gov/study/NCT06026709.

Keywords: Multimorbidity; clinical trials; digital health; mental health; smartphone.

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Conflict of interest statement

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

**Figure 1.**
CONSORT flowchart of the study procedure.

**Figure 2.**
Screenshots of intervention modules in *EmoEase*.

See this image and copyright information in PMC

References

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Effectiveness and cost-effectiveness of an integrated digital psychological intervention (EmoEase) in Chinese chronic obstructive pulmonary disease patients: Study protocol of a randomized controlled trial

Affiliations

Effectiveness and cost-effectiveness of an integrated digital psychological intervention (EmoEase) in Chinese chronic obstructive pulmonary disease patients: Study protocol of a randomized controlled trial

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Associated data

LinkOut - more resources

Full Text Sources

Medical