NCT07821385

Brief Summary

Since 2020, millions of individuals have been infected with SARS-CoV-2 virus and a substantial proportion continue to experience persistent symptoms that impair functional capacity, limit daily activities, and negatively affect quality of life. The terminology and definitions surrounding this condition remain diverse, such as long COVID, post-COVID-19 syndrome or ongoing symptomatic COVID-19 . In October 2021, the World Health Organization (WHO) introduced the term post-COVID condition (PCC) through a Delphi consensus process defined as: "As the persistence or onset of new symptoms three months after the initial SARS-CoV-2 infection, with symptoms lasting for at least two months and not explained by alternative diagnoses". PCC is characterized by a wide range of symptoms, most commonly fatigue, cognitive impairments, muscle weakness, respiratory and cardiac symptoms, and pain often occurring alongside anxiety, depression, and sleep disturbances. Research shows that PCC markedly impairs activities of daily living (ADL), work ability, and overall functioning. Qualitative studies further demonstrate that the combination of physical and cognitive symptoms limits individuals' ability to engage in everyday occupations and reduce work capacity. Consequently, PCC is associated with difficulties in maintaining employment, often resulting in prolonged sick leave, reduced working hours, or the need for workplace accommodations. Given the heterogeneous nature of PCC, its impact on everyday life varies between individuals, highlighting the importance of understanding patients´ own experiences and priorities when planning rehabilitation interventions. Global efforts have focused on understanding and managing PCC, with rehabilitation emerging as a central strategy. Rehabilitation strategies seem to be a key intervention for improving fatigue, cognitive dysfunction, mood disturbances, and decrease overall well-being; however, current evidence is heterogeneous and insufficient to establish standardized interventions. A lack of research on PCC patients would lead to profound consequences for both patients and society. Without such knowledge, patients' risk of being misdiagnosed or receiving inadequate care, rehabilitation efforts may be ineffective, and healthcare systems will struggle to allocate resources properly. This increases long-term disability, reduces work ability, and places an avoidable burden on individuals and society. Therefore, a deeper understanding of the scope and nature of PCC is essential for understanding this patient group better, developing effective rehabilitation approaches and informing public health policy. The goal of this observational study is to learn more about the impact of post-COVID condition (PCC) on individuals' everyday occupational performance, cognitive functioning, perceived health, and life satisfaction, with the aim of understanding these patient groups better, and to generate evidence to guide rehabilitation strategies. The research focuses on patients diagnosed with post-COVID condition who are receiving an interprofessional rehabilitation program at a specialized Rehabilitation Clinic in Sweden, Danderyds Hospital, The main questions aim to answer are:

  • Which activities do individuals with PCC identify as most important to improve, and how do they rate these activities in terms of performance and satisfaction?
  • How do individuals with PCC rate their overall health and occupational performance before and after participating in an interprofessional rehabilitation program?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

4.4 years

First QC Date

September 10, 2026

Last Update Submit

September 10, 2026

Conditions

Keywords

Rehabilitation, Everyday occupations, Health, Life Satisfaction

Outcome Measures

Primary Outcomes (1)

  • Canadian Occupational Performance Measure (COPM)

    The COPM assesses an individual's perceived occupational performance in the areas of self-care, productivity and leisure. Semi-structured interview format and structured scoring method. The person rates/ describes which activities are important for them and after that satisfaction. The person rates importance, performance and satisfaction

    Before, after and at six months follow-up

Secondary Outcomes (6)

  • EQ5D

    Before, after and at six month follow-up

  • HADS

    Before, after and six month follow-up

  • Rand-36

    Before, after and a six months follow-up

  • MFI-20

    Before, after and at six months follow-up

  • ISI

    Before, after and at six month follow-up

  • +1 more secondary outcomes

Study Arms (1)

Patients with Post-COVID condition

The study aims to investigate a cohort of patients with post COVID condition whose primary symptoms are cognitive impairment and fatigue. The patients have undergone a comprehensive assessment by a multiprofessional team and have been deemed both to require and to be capable of participating in an on site interprofessional rehabilitation program conducted one day per week.

Other: Interprofessional cognitive group rehabilitation

Interventions

The Interprofessional rehabilitation program (IPR) was delivered in a group format, one half day per week over 10 weeks. The interprofessional team comprised an occupational therapist, psychologist, physiotherapist, physician, and social worker. All patients underwent an initial team assessment to determine eligibility for the IRP. Based on this assessment; an individualized rehabilitation plan was developed prior to program initiation. The IPR included lectures, group discussions, and physical activity, with the overall goal of improving daily functioning and facilitating return to work when applicable.

Patients with Post-COVID condition

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18-65 with persistent cognitive symptoms and fatigue following confirmed or strongly suspected COVID-19 infection, who have undergone assessment at the Cognitive Post-COVID Clinic at Danderyd Hospital and subsequently completed a team evaluation prior to participation in interdisciplinary rehabilitation. During the assessment, it is determined whether the patient needs and can benefit from rehabilitation.

You may qualify if:

  • Individuals aged 18 and older with confirmed COVID-19 or with a very likely prior COVID-19 infection.
  • Newly developed cognitive impairments or cognitive fatigue.
  • A clear temporal link between COVID-19 onset and symptom onset, with symptoms affecting return to previous activities/occupation.
  • The acute phase of illness ended at least 3 months earlier.
  • Basic investigations for specific differential diagnoses must have been completed at the initial clinic visit, according to "COVID-19 - persistent symptoms" (see viss.nu), excluding anemia, thyroid dysfunction, and alcohol overconsumption. Assessment for depression.
  • Medication review and relevant adjustments carried out with regard to the patient's symptoms

You may not qualify if:

  • Predominant recurrent and/or fluctuating infectious symptoms, circulatory, respiratory, or cardiac problems.
  • Other symptoms due to organ failure that should primarily be managed by an organ specialist.
  • Severe psychiatric illness, including depression with pronounced cognitive symptoms.
  • Cognitive impairments primarily related to neurodegenerative disease or substance misuse, e.g., alcohol-related dementia, Korsakoff's dementia, or other dementia disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitaiton Medicine Stockholm

Stockholm, 18288, Sweden

Location

Related Publications (26)

  • Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

    PMID: 11438246BACKGROUND
  • Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.

    PMID: 7636775BACKGROUND
  • Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001 Jul;33(5):350-7. doi: 10.3109/07853890109002089.

    PMID: 11491194BACKGROUND
  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PMID: 6880820BACKGROUND
  • Balestroni G, Bertolotti G. [EuroQol-5D (EQ-5D): an instrument for measuring quality of life]. Monaldi Arch Chest Dis. 2012 Sep;78(3):155-9. doi: 10.4081/monaldi.2012.121. Italian.

    PMID: 23614330BACKGROUND
  • Pollini E, Lazzarini SG, Cordani C, Del Furia MJ, Kiekens C, Negrini S, Arienti C. Effectiveness of Rehabilitation Interventions on Adults With COVID-19 and Post-COVID-19 Condition. A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2024 Jan;105(1):138-149. doi: 10.1016/j.apmr.2023.08.023. Epub 2023 Oct 5.

    PMID: 37802177BACKGROUND
  • Zeraatkar D, Ling M, Kirsh S, Jassal T, Shahab M, Movahed H, Talukdar JR, Walch A, Chakraborty S, Turner T, Turkstra L, McIntyre RS, Izcovich A, Mbuagbaw L, Agoritsas T, Flottorp SA, Garner P, Pitre T, Couban RJ, Busse JW. Interventions for the management of long covid (post-covid condition): living systematic review. BMJ. 2024 Nov 27;387:e081318. doi: 10.1136/bmj-2024-081318.

    PMID: 39603702BACKGROUND
  • Ballouz T, Kerksieck P, Haile SR, Dressel H, Hammig O, Bauer GF, Fehr JS, Puhan MA, Menges D. Work ability trajectories and sick leave in individuals with post COVID-19 condition: 3-year follow-up of a population-based cohort. Lancet Reg Health Eur. 2025 Nov 20;61:101536. doi: 10.1016/j.lanepe.2025.101536. eCollection 2026 Feb.

    PMID: 41362299BACKGROUND
  • Kerksieck P, Ballouz T, Haile SR, Schumacher C, Lacy J, Domenghino A, Fehr JS, Bauer GF, Dressel H, Puhan MA, Menges D. Post COVID-19 condition, work ability and occupational changes in a population-based cohort. Lancet Reg Health Eur. 2023 Jun 23;31:100671. doi: 10.1016/j.lanepe.2023.100671. Online ahead of print.

    PMID: 37366496BACKGROUND
  • MacEwan SR, Rahurkar S, Tarver WL, Eiterman LP, Melnyk H, Olvera RG, Eramo JL, Teuschler L, Gaughan AA, Rush LJ, Stanwick S, Burpee SB, McConnell E, Schamess A, McAlearney AS. The Impact of Long COVID on Employment and Well-Being: A Qualitative Study of Patient Perspectives. J Gen Intern Med. 2025 Apr;40(5):1070-1077. doi: 10.1007/s11606-024-09062-5. Epub 2024 Oct 8.

    PMID: 39379779BACKGROUND
  • Hawke LD, Nguyen ATP, Sheikhan NY, Strudwick G, Rossell SL, Soklaridis S, Kloiber S, Shields R, Ski CF, Thompson DR, Castle D. Swept under the carpet: a qualitative study of patient perspectives on Long COVID, treatments, services, and mental health. BMC Health Serv Res. 2023 Oct 11;23(1):1088. doi: 10.1186/s12913-023-10091-9.

    PMID: 37821939BACKGROUND
  • Rosenstein J, Lemhofer C, Loudovici-Krug D, Sturm C, Bokel A. Impact of post-COVID symptoms on activity and participation of women and men. Sci Rep. 2024 Oct 17;14(1):24379. doi: 10.1038/s41598-024-74568-1.

    PMID: 39420197BACKGROUND
  • Ottiger M, Poppele I, Sperling N, Schlesinger T, Muller K. Work ability and return-to-work of patients with post-COVID-19: a systematic review and meta-analysis. BMC Public Health. 2024 Jul 7;24(1):1811. doi: 10.1186/s12889-024-19328-6.

    PMID: 38973011BACKGROUND
  • Pizarro-Pennarolli C, Sanchez-Rojas C, Torres-Castro R, Vera-Uribe R, Sanchez-Ramirez DC, Vasconcello-Castillo L, Solis-Navarro L, Rivera-Lillo G. Assessment of activities of daily living in patients post COVID-19: a systematic review. PeerJ. 2021 Apr 6;9:e11026. doi: 10.7717/peerj.11026. eCollection 2021.

    PMID: 33868804BACKGROUND
  • Zakia H, Pradana K, Iskandar S. Risk factors for psychiatric symptoms in patients with long COVID: A systematic review. PLoS One. 2023 Apr 7;18(4):e0284075. doi: 10.1371/journal.pone.0284075. eCollection 2023.

    PMID: 37027455BACKGROUND
  • Fernandez-de-Las-Penas C, Notarte KI, Macasaet R, Velasco JV, Catahay JA, Ver AT, Chung W, Valera-Calero JA, Navarro-Santana M. Persistence of post-COVID symptoms in the general population two years after SARS-CoV-2 infection: A systematic review and meta-analysis. J Infect. 2024 Feb;88(2):77-88. doi: 10.1016/j.jinf.2023.12.004. Epub 2023 Dec 13.

    PMID: 38101521BACKGROUND
  • Talkington GM, Kolluru P, Gressett TE, Ismael S, Meenakshi U, Acquarone M, Solch-Ottaiano RJ, White A, Ouvrier B, Pare K, Parker N, Watters A, Siddeeque N, Sullivan B, Ganguli N, Calero-Hernandez V, Hall G, Longo M, Bix GJ. Neurological sequelae of long COVID: a comprehensive review of diagnostic imaging, underlying mechanisms, and potential therapeutics. Front Neurol. 2025 Feb 7;15:1465787. doi: 10.3389/fneur.2024.1465787. eCollection 2024.

    PMID: 40046430BACKGROUND
  • Elboraay T, Ebada MA, Elsayed M, Aboeldahab HA, Salamah HM, Rageh O, Elmallahy M, AboElfarh HE, Mansour LS, Nabil Y, Eltawab AKA, Atwan H, Alkanj S. Long-term neurological and cognitive impact of COVID-19: a systematic review and meta-analysis in over 4 million patients. BMC Neurol. 2025 Jun 14;25(1):250. doi: 10.1186/s12883-025-04174-9.

    PMID: 40514644BACKGROUND
  • Santoro A, Bai F, Greco MF, Rovito R, Sala M, Borghi L, Piscopo K, Vegni E, de Morais Caporali JF, Marinho CC, Leite AS, Santoro MM, Silberstein FC, Iannetta M, Juozapaite D, Strumiliene E, Almeida A, Toscano C, Quinones JAR, Carioti L, Mommo C, Fanti I, Incardona F, Marchetti G; EuCARE POSTCOVID study. Short and long-term trajectories of the post COVID-19 condition: Results from the EuCARE POSTCOVID study. BMC Infect Dis. 2025 Apr 29;25(1):625. doi: 10.1186/s12879-025-10805-w.

    PMID: 40301791BACKGROUND
  • Soriano JB, Murthy S, Marshall JC, Relan P, Diaz JV; WHO Clinical Case Definition Working Group on Post-COVID-19 Condition. A clinical case definition of post-COVID-19 condition by a Delphi consensus. Lancet Infect Dis. 2022 Apr;22(4):e102-e107. doi: 10.1016/S1473-3099(21)00703-9. Epub 2021 Dec 21.

    PMID: 34951953BACKGROUND
  • Al-Aly Z, Davis H, McCorkell L, Soares L, Wulf-Hanson S, Iwasaki A, Topol EJ. Long COVID science, research and policy. Nat Med. 2024 Aug;30(8):2148-2164. doi: 10.1038/s41591-024-03173-6. Epub 2024 Aug 9.

    PMID: 39122965BACKGROUND
  • Moller M, Borg K, Janson C, Lerm M, Normark J, Niward K. Cognitive dysfunction in post-COVID-19 condition: Mechanisms, management, and rehabilitation. J Intern Med. 2023 Nov;294(5):563-581. doi: 10.1111/joim.13720. Epub 2023 Sep 27.

    PMID: 37766515BACKGROUND
  • Norrefalk JR, Borg K, Bileviciute-Ljungar I. Self-scored impairments in functioning and disability in post-COVID syndrome following mild COVID-19 infection. J Rehabil Med. 2021 Nov 23;53(11 (November)):jrm00239. doi: 10.2340/jrm.v53.188.

    PMID: 34643243BACKGROUND
  • Greenhalgh T, Sivan M, Perlowski A, Nikolich JZ. Long COVID: a clinical update. Lancet. 2024 Aug 17;404(10453):707-724. doi: 10.1016/S0140-6736(24)01136-X. Epub 2024 Jul 31.

    PMID: 39096925BACKGROUND
  • Ceban F, Ling S, Lui LMW, Lee Y, Gill H, Teopiz KM, Rodrigues NB, Subramaniapillai M, Di Vincenzo JD, Cao B, Lin K, Mansur RB, Ho RC, Rosenblat JD, Miskowiak KW, Vinberg M, Maletic V, McIntyre RS. Fatigue and cognitive impairment in Post-COVID-19 Syndrome: A systematic review and meta-analysis. Brain Behav Immun. 2022 Mar;101:93-135. doi: 10.1016/j.bbi.2021.12.020. Epub 2021 Dec 29.

    PMID: 34973396BACKGROUND
  • Xie NN, Zhang WC, Chen J, Tian FB, Song JX. Clinical Characteristics, Diagnosis, and Therapeutics of COVID-19: A Review. Curr Med Sci. 2023 Dec;43(6):1066-1074. doi: 10.1007/s11596-023-2797-3. Epub 2023 Oct 14.

    PMID: 37837572BACKGROUND

Related Links

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Monika Löfgren, Assoc Prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 15, 2026

Study Start

August 20, 2021

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

September 15, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Data might be shared on request.

Locations