Long COVID Infections and Infestations COVID-19 (SARS-CoV-2 infection)
Conditions
Interventions
Randomisation:
Participants will be randomised following the receipt of baseline data to either intervention or control group via a computer-generated block randomization. To avoid bias, an independen
in inpatient and outpatient settings, at homes, or by video conferencing, and to groups or to individuals consumers.
In this trial, recognising that fatigue is a core component, the OHP for long COV
Sponsors
University of Suffolk
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult (18+ years with no upper age limit). 2. COVID-19 infection confirmed through PCR testing or clinical diagnosis from GP. 3. Experiencing post-COVID-19 syndrome (as defined by NICE 2020) 12 weeks or more following onset of symptoms / confirmed through testing. 4. Able to participate in telephone interview in English language (or with accommodated adjustments). 5. Able to consent to participate in study.
Exclusion criteria
Exclusion criteria: 1. Children and young adults (17 years and under). 2. Unable to consent to participate in study, despite reasonable adjustments being implemented. 3. Unable to participate in telephone interview in English language, where the research team have been unable to make adjustments to enable their participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and acceptability measured by: 1. Recruitment and retention rates measured by identifying the number of participants taking part in the study (from start to end) and number of participants who withdraw from the study at any point. 2. Acceptability and satisfaction of the LC-OHP measured by: 2.1. Conducting a telephone interview with a sample of participants in the intervention group at the end of the trial 2.2. Asking participants in the intervention group to complete the Course Experience Questionnaire (CEQ) at the end of the trial Participants who decide to withdraw from the trial will also be invited to a short interview to assess their views of the LC-OHP and any changes that they may wish to suggest. Interviews will be held as soon after they withdraw 3. Acceptability of secondary outcome measures measured using telephone interview with a sample of participants in the intervention group at the end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, and at 3 and 6 months post-randomisation: 1. Depression measured using the Patient Health Questionnaire (PHQ-9) 2. Anxiety measured using the Generalised Anxiety Disorder Assessment (GAD-7) 3. Self-efficacy measured using the General Self-Efficacy Scale (GSE) 4. Quality of life measured using the EQ-5D-5L questionnaire 5. Fatigue Assessment Scale (FAS) | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed