Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 19, 2025
Date Accepted: Nov 10, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Tailored Individual Follow-ups versus a One-day Group Course in Patients with long COVID (post COVID-19 condition): Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
The high prevalence of patients with post COVID -19 condition, also called long COVID, even among those with mild initial disease, will may have a large impact on both the individual and society. Disability in everyday life, reduced health-related quality of life and work capacity, strain on the healthcare system and substantial socioeconomic costs are associated withto long COVID. More research to investigate the effectiveness of rehabilitation services is warranted.
Objective:
The purpose of this study is to examine the effectiveness of tailored individual follow-ups versus a one-day group course in patients with long COVID. Additionally, the feasibility and utility of a mobile application for self-monitoring goal achievement will be assessed.
Methods:
This is a single-center, parallel-group, superiority randomized controlled trial (RCT) with a 1:1 allocation ratio. A total of 62 outpatients aged 18–65 years with long COVID will be randomized to either a rehabilitation program with individual follow-up consultations or a one-day self-management group course. The individual intervention incorporates setting goals, teaching cognitive-behavioral strategies, energy management (pacing), and a supervised gradual increase in both physical and cognitive activities tailored to individual tolerance levels. The primary outcome is the between-group difference in health-related quality of life, measured using the EQ-5D-5L at 6 months. Secondary outcomes include improvements in symptoms, work participation, neurocognitive function, and app usability, assessed at 3, 6, and 12 months depending on the outcome measure.
Results:
Data enrolment started in October 2023. A total of 62 participants were included by November 2024. Data collection is planned to be completed in November 2025.
Conclusions:
Long COVID poses significant challenges for both individuals and society, underscoring the need for effective rehabilitation strategies. This study will provide valuable insights into the benefits of an individualized outpatient rehabilitation program. The results from this clinical trial will help guide future treatment recommendations and may improve long-term outcomes for affected patients. Additionally, the study will generate important knowledge about neuropsychological function and digital self-management tools in long COVID rehabilitation. Clinical Trial: Clinical trials: the randomized controlled trial is registered in clinicaltrials.gov under identifier NCT06085911.
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