Long Covid and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) Other
Conditions
Interventions
The HERITAGE study will use a mixed-methods design, combining quantitative and qualitative data from individuals with Long Covid (LC) and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) re
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for WP1 and WP2: 1. Aged 18 years and over 2. All genders 3. Ability to provide informed consent 4. Have had symptoms of persistent LC or ME/CFS for >2 years Clinic cohort: 1. Individuals who at study baseline, have received, are currently receiving or are about to receive (i.e., known appointment date within 2 years (persistent LC) Staff cohort: 1. Working within, referring to, or involved in providing, planning, or supporting LC/ME/CFS specialist services in Leeds, Leicester, Hertfordshire or Cornwall (HERITAGE Clinics) 2. Identified and approached by site Principal Investigators or Clinical Research Fellows The Quality Improvement Collaborative (QIC) cohort: 1. People involved in providing, referring to, or receiving LC/ME/CFS specialist services at the participating NHS sites 2. May include staff, p
Exclusion criteria
Exclusion criteria: Exclusion criteria for WP1 and WP2: Clinic cohort: 1. Individuals who, during follow-up, receive an alternative diagnosis or enter non-HERITAGE specialist services will be withdrawn from follow-up for WP1/WP2 2. Individuals will be excluded if they are receiving or due to receive LC/ME/CFS specialist care at an NHS service not participating in HERITAGE 3. Individuals unable to consent or aged under 18 years will be excluded Exclusion criteria for WP3: Participants will be excluded from WP3 if: 1. They cannot provide informed consent for qualitative activities 2. They are too unwell to take part safely or meaningfully, even with breaks and adjustments WP3 non-clinic cohort – exclusion criteria: Participants will be excluded from WP3 if: 1. They cannot provide informed consent for qualitative participation 2. They are unable to participate safely or meaningfully in an interview, even with reasonable adjustments 3. English-language communication is insufficient for qualitative data collection Carers (WP3 only) – exclusion criteria: 1. Carers may be involved only when supporting a WP3 participant (patient) during: 1.1. Interviews 1.2. Clinic observations, or 1.3. QIC meetings 2. Carers will be excluded if: 2.1. They are aged under 18 years 2.2. They cannot provide informed consent 2.3. Their participation would introduce safeguarding concerns, or 2.4. They are unable to participate safely or meaningfully in the activity 2.5. Carers are not independently recruited into WP1, WP2 or WP3 and do not have clinical inclusion/exclusion criteria beyond the above Staff (WP3) exclusion criteria: Staff participants will be excluded if: 1. They do not work in, refer to, or support specialist LC/ME/CFS services at participating HERITAGE NHS sites 2. Their employing NHS organisation does not grant permission for participation 3. Individuals will be excluded from QIC participation if they do not work within, receive care from, or provide support to LC/ME/CFS specialist services at participating HERITAGE NHS sites 4. Individuals will be excluded from QIC participation, if they are unable to participate safely or meaningfully in QIC meetings 5. Individuals will be excluded from QIC participation, if they are unable to attend the scheduled QIC sessions Exclusion criteria for all work packages: 1. Individuals under 18 years of age 2. Individuals unable to provide informed consent 3. Individuals who do not have experience of Long Covid (LC) or ME/CFS healthcare needs and therefore do not meet study aims 4. Individuals for whom participation is deemed inappropriate due to safeguarding or clinical concerns, based on advice from their GP or usual clinical team
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Diagnostic overlap between Long Covid and ME/CFS is assessed using participant-reported diagnostic information collected via the HERITAGE general health questionnaire at baseline and at 3, 6, 9 and 12 months 2. Healthcare utilisation and health and social care costs are measured using a bespoke health economics questionnaire and linked routine service use data at baseline and at 3, 6, 9 and 12 months 3. Vocational outcomes, including employment status, working hours, and return to work status, are measured using participant self-report questionnaires at baseline and at 3, 6, 9 and 12 months 4. Patient experience, equity of access, and quality of care are explored through qualitative interviews, ethnographic observations, and outputs from the Quality Improvement Collaborative (QIC), conducted once per participant for interviews and longitudinally across the study period for observations and QIC activities | — |
Countries
England, United Kingdom
Contacts
Public ContactManoj Sivan
Outcome results
None listed