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The present study is a 2-arm pragmatic randomised controlled trial (RCT) in which 310 patients who suffer from post-Covid syndrome are randomised to either a short-time outpatient-based rehabilitation program (the intervention) or care as usual in a 1:1 ratio. Assessments will take place immediately before randomisation (T0), after intervention or care as usual (T1), and 6 months after T1 (T2). Patients will be recruited from General Practitioners (GP's) as well as social media and self-referral to the involved institutions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-time rehabilitation | Active Comparator | The intervention consists of an individualized numbers of outpatient encounters (min. 2, max. 8) with medical doctors and physiotherapists at Kysthospitalet, Stavern, Norway. The encounters aim to foster a rehabilitation process based upon principles from Cognitive Behavioral Therapy (CBT) |
|
| Care as usual | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation based on CBT principles | Behavioral | Cf. arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Functioning | Physical Functioning subscale from the SF-36 inventory. The SF-36 comprises a total of 36 items on subjective mental, social and physical health, which are assigned to 8 dimensions. Scale ranging from 0 (poor quality of life) to 100 (best) | Immediately after intervention (time T1) |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Chalder Fatigue Questionnaire (CFQ), total sum score. Range from 0-33, higher scores means more fatigue. | Immediately after intervention (time T1) |
| Fatigue | Chalder fatigue questionnaire, total sum score |
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Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Vegard B Wyller | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vegard Bratholm Wyller | Oslo | 1170 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42032661 | Derived | Nerli TF, Selvakumar J, Heier I, Johnsen TL, Wyller VBB, Wisloff T. Cost-effectiveness of a brief cognitive-behavioral outpatient rehabilitation program for patients with post-COVID-19 condition within a pragmatic randomized controlled trial. Cost Eff Resour Alloc. 2026 Apr 24;24(1):73. doi: 10.1186/s12962-026-00748-7. | |
| 39699896 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2022 | Feb 20, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 23, 2022 | Feb 23, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| At 12 months follow-up (time T2) |
| Depression/anxiety | Hospital Anxiety and Depresssion Scale, total score. Higher scores means more depression/anxiety symptoms. | Immediately after intervention (time T1) |
| Depression/anxiety | Hospital Anxiety and Depresssion Scale, total score | At 12 months follow-up (time T2) |
| Adverse effects | Self-invented questionnaire on adverse effects | Immediately after intervention (time T1) |
| Adverse effects | Self-invented questionnaire on adverse effects | At 12 months follow-up (time T2) |
| Physical Functioning | Physical Functioning subscale from the SF-36 inventory | At 12 months follow-up (time T2) |
| Recovery from PIFS | Recovery from post-infective fatigue syndrome (PIFS) | Immediately after intervention (time T1) |
| Recovery from PIFS | Recovery from post-infective fatigue syndrome (PIFS) | At 12 months follow-up (time T2) |
| Nerli TF, Selvakumar J, Cvejic E, Heier I, Pedersen M, Johnsen TL, Wyller VBB. Brief Outpatient Rehabilitation Program for Post-COVID-19 Condition: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2450744. doi: 10.1001/jamanetworkopen.2024.50744. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |