Improvement in quality of life and cognitive function in Post Covid Syndrome after online occupational therapy: results from a randomized controlled pilot study

Abstract

Background: Post-COVID-Syndrome (PCS) poses enormous clinical challenges. Occupational therapy (OT) is recommended in PCS, but structural validation of this concept is pending. Methods: In an unblinded randomized pilot study (clinical trial # DRKS0026007), feasibility and effects of online OT in PCS were tested. Probands received structured online OT over 12 weeks either via interactive online treatment sessions (interactive group) or prerecorded videos (video group). 50% of probands received no online OT (control group). At week 0, 12, and 24, we analyzed study experience, health-related quality of life, and impairment in performance, participation, and cognitive functions. Results: N=158 probands (mean age 38 yrs., 86% female) were included into the analyses. 83.3% of probands in the interactive versus 48.1% of probands in the video group described their study experience as positive or very positive (p=0.001). After 12 weeks, all groups displayed significant improvement in concentration, memory, and performance of daily tasks. After 24 weeks, significant improvement in concentration and memory were observed in control- and video-probands, and social participation had improved after video-OT. However, only probands that had received interactive online OT showed improvement of all measured endpoints including concentration, memory, quality of life, and social participation. Conclusion: We show that online OT is feasible and that interactive online OT is a promising treatment strategy for affected patients. We present exploratory data on its efficacy and describe variables that can be employed for further investigations in confirmatory trials.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

The study was registered at the German Registry for Clinical Trials (trial number DRKS00026007).

Clinical Protocols

DOI:10.2196/preprints.50230

Funding Statement

Yes

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study protocol was approved by responsible research ethics boards of all participating centers (Hannover Medical School #9948_BO_K_2021, University Medical Center Göttingen 15/8/22Ü).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

Data cannot be shared publicly because they contain personal information. Data are available from the Hannover Medical School Institutional Data Access (contact via Study director PD Dr. med. Alexandra Jablonka Clinic for Immunology and Rheumatology - OE 6830 Hanover Medical School Carl Neuberg Strasse 1 30625 Hannover Email: Jablonka.Alexandra@mh-hannover.de Phone: +49 511 532 3014) for researchers who meet the criteria for access to confidential data.

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