Long COVID Infections and Infestations
Conditions
Interventions
Following completion of baseline data participants will be allocated to one of the two groups using a mixed minimisation/randomisation approach. 80% of participants will be allocated according to mini
Sponsors
NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. People with Long COVID symptoms persisting >3 months before first recruitment contact, not currently hospitalised 2. People who are aged 18 or above 3. People with body mass index (BMI) above 27 kg/m² (>25 kg/m² for South Asians)
Exclusion criteria
Exclusion criteria: 1. People who have had lengthy hospitalisations (>10 days) or intensive care unit (ICU) admissions related to COVID-19 2. People who are currently on insulin or anti-obesity drugs 3. People who have had a proven myocardial infarction within the last 6 months 4. People with severe mental illness (including severe depression and eating disorders)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be a continuous measure derived from the symptom score for the most important Long COVID symptom reported by the participant at baseline, 3 and 6 months, with the 6-month measure the primary outcome. Participants will complete symptom scores at baseline and will nominate the symptom they would most like to improve: 1. Fatigue measured using the Validated Chalder Fatigue Scale (CFQ-11) 2. Breathlessness measured using the modified MRC Dyspnoea Scale 3. Pain measured using the P4 Numeric Pain Rating Scale 4. Anxiety and depression measured using the Hospital Anxiety & Depression Scale (HADS) questionnaire 5. Other - for other symptoms with no pre-specified scale, the researchers will use a Visual Analogue Scale (0 to 10) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, 3 and 6 months: 1. The symptoms not nominated by each participant as their primary outcome measure (listed above) will become secondary outcomes 2. Quality of life measured using the EQ-5D-5L 3. Work productivity measured using the Work Productivity and Activity Impairment (WPAI) questionnaire 4. Weight in kg will be measured by self-reporting (participants will be sent their own weight scales) 5. A process evaluation will assess the implementation of the intervention in terms of dose, fidelity and reach and explore the experience of the intervention from the perspective of participants including acceptability, patterns of use, and barriers and facilitators to use. This will be done using semi-structured interviews. 6. Cost-effectiveness of the intervention assessed using an economic evaluation | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactDiann Taggart
Outcome results
None listed