post-COVID syndrome
Conditions
Interventions
Group 1: To answer the primary and two of the secondary research questions , a R-SCED design will be used. This R-SCED will be performed at Adelante Zorggroep, location MUMC+, which is a rehabilitatio
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: To be eligible for participation in this study, patients must meet all the following criteria: - COVID-19 symptoms persisting for more than 12 weeks after initial infection, - Experiencing high levels of disability in daily activities and/or participation due to PCS (rehabilitation physician based). - Indicated for an interdisciplinary rehabilitation treatment in secondary care (as decided by a rehabilitation physician). - Good command of written and spoken Dutch - Having access to the Internet
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Illiteracy / no good knowledge of Dutch - No access to a smartphone, tablet or computer (or insufficient digital skills) - Experiencing high levels of disability in daily activities and/or participation before their COVID-19 infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participation in society was assessed by the ‘Utrecht Scale for Evaluation of Rehabilitation Participation’ (USER-P). The USER-P consists of three subscales: frequency of activities, the restriction subscale and the satisfaction subscale. The Frequency subscale of the USER-P consists of 11 items and is divided into parts A and B. Part A measures the time that an individual has spent on paid work, unpaid work, volunteer work and housekeeping using scores from 0 (‘not at all’) to 5 (‘36 hours or more’). Part B registers the frequency of leisure and social activities during the past 4 weeks, with scores ranging from 0 (‘not possible at all’) to 5 (‘19 times or more’). The USER-P restriction subscale consists of 11 items on restrictions in vocational, leisure, and social activities. Items are rated from 0 (‘not possible’) to 3 (‘without difficulty’) and a ‘not applicable’ option. The satisfaction subscale consists of 10 items that measure satisfaction. Items are rated from 0 (‘very dissatisfied’) to 4 (‘very satisfied’). For all three subscales, the total score ranges from 0 to 100, higher scores indicating better participation. Health-related quality of life (HRQOL) is evaluated with the 5-dimension descriptive system (EQ5D-5L) and associated visual analogue scale (VAS). The EQ5D-5L includes five domains, namely mobility, self-care, usual activities, pain and anxiety/depression. Each dimension is rated on a 5-level scale from ‘no problems’ to ‘unable’. For the resulting five-digit EQ-5D health profile, a weighted EQ index was calculated using Dutch reference values. The EQ5D-5L VAS asks the respondent to rate their perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating higher quality of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily diary: to assess daily changes a short (11-item) questionnaire was used. The daily diaries consist of 9 questions from validated questionnaires (USER-P and quality of life (VAS), HADS and iMCQ). Each question is rated on a scale from 0-10. Furthermore, the daily dairy will focus on the two most important individual goals (the participant will be asked to reach each goal on performance and satisfaction, on a scale from 0-10). The daily diary measurements will be administered on a daily basis during phase A and B and C. Perceived limitations in daily life functioning are assessed using the patient-reported outcomes measurement information system (PROMIS) physical function short form 8b. This survey was created for adults with chronic illnesses and has eight questions. Each of the eight items ranges from 1 (‘unable to do’) to 5 (‘without any difficulty’), where higher scores indicate better physical function. A web-based scoring service was used to calculate T-scores (maximum score 60.1 and mean 50.0, corresponding to the mean in the general population of the USA), where a higher score indicates better physical function. Fatigue will be evaluated by the Multidimensional Fatigue Inventory (MFI), which is a 20-item metric for fatigue severity. It has five dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Each item ranges from 1 (absence of fatigue) to 5 (severe fatigue). A total score is calculated as the sum of the subscale scores (20–100). Higher scores indicate higher levels of fatigue. Breathlessness will be assessed by the Medical Research Council (MRC) breathlessness scale, which comprises five statements ranging from 0 (no trouble with breathlessness) to 5 (I am too breathless to leave the house). Pain will be assessed by the Numerical Rating Scale. Patients are asked to rate their mean pain intensities in the last 7 days, ranging from 0 to 10, with 0 indicating ‘no pain’ and 10 indicating ‘the wors | — |
Countries
Netherlands
Contacts
Public ContactJeanine Verbunt
Maastricht University
Outcome results
None listed