About the project
SIPCOV is a pragmatic randomised controlled trial on the efficacy and safety of a short-time outpatient-based rehabilitation program as compared to usual care in the post-COVID-19 condition.
A total of n=310 participants has been included.
Method
SIPCOV 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 12 months after T0 (T2).
Of note, the timing of T1 will vary in the intervention group, due to the individualized therapy approach (cf. below); T1 in the non-intervention group will be matched accordingly.
Patients will be recruited from General Practitioners (GP’s) as well as social media and self-referral to the involved institutions.
Patients eligible for the present study are randomized to either intervention or care as usual in a 1:1 probability by a computer-based routine for block randomization; block size will vary randomly between 4 and 6.
Allocation will be stratified by severity of illness during the acute stage of COVID-19, operationalized as (1) no admission to hospital, (2) admission to hospital.
The intervention consists of 2 - 8 outpatient appointments depending on participant’s needs. The first appointment is with a medical doctor, subsequent appointments are with a physiotherapist.
Principles of cognitive behavioural therapy and graded exercise therapy are applied throughout.
Effect monitoring is primarily based on patient reported outcome measures (PROM), applying a web-based questionnaire composed of several validated instruments. The questionnaire will be distributed to the participants at T0, T1 and T2. It will chart clinical symptoms as well as background, psychological and social variables, and will be used for subgrouping according to case definitions of post-COVID-19 syndrome and post-infective fatigue syndrome.
In addition, employment status, usage of social security-systems such as short and long-term sick leave, and usage of health care services (i.e. the number of GP and specialist contacts, hospitalisations, medications, usage of rehabilitation services, etc.) will be charted through register linkage as well as questionnaires to the study participants.
Objective
The aim of the study is to find out whether short-term rehabilitation for patients suffering from post-COVID syndrome is effective.
The SF-36 subscale Physical Functioning (SF-36-PFS) score at T1 will serve as the primary endpoint.
Secondary endpoints include score of PROM inventories at T1 and T2 addressing fatigue, dyspnea, cognitive difficulties, sleep problems, and other symptoms, as well as functional capacity and quality of life.
Cooperation
- Andreas Horsdal, Head of Physical medical department, Kysthospitalet, Vestfold Hospital Trust
- Gro E. Aasland, Clinic manager, Physical Medicine and Rehablitation, Kysthospitalet, Vestfold Hospital Trust
- Professor Silje Endresen Reme, Department of Psychology, Faculty of social science, University of Oslo
- Associate Professor Henrik Børsting Jacobsen, Department of Psychology, Faculty of social science, University of Oslo
- Signe Flottorp, Research Director, Norwegian Institute of Public Health
- The COFFI collaborative (external page)