Long COVIDNCT06223997
The Impact of Long COVID on People Living With Pre-existing LTC
An observational study of Long COVID and Multiple Chronic Conditions, run by University of Leicester.
Trial summary
The goal of this observational study is to learn about the impact of long COVID on people who have multiple (two or more) pre-existing long-term conditions (such as diabetes and asthma). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID, Multiple Chronic Conditions
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be individuals living with multiple (≥2) pre-existing long-term conditions and long COVID or 'post-COVID-19 condition' (in accordance with the World Health Organisation definition) or carer/supporter for someone who is; identified and recruited via University Hospitals of Leicester NHS Trust. Participants will be living in Leicester (UK) and either able to take photographs themselves or have a carer/supporter who is able and willing to do this for them.
Who may be able to join
- Adult (≥18 years) living with long COVID (or 'post-COVID-19 condition' in accordance with the World Health Organisation definition) and ≥2 pre-existing long-term conditions or carer/supporter for someone who is
- Living in Leicester (UK)
- Able to take photographs or carer/supporter who is able and willing
- Able and willing to provide informed consent
Who cannot join
- Child (<18 years)
- Unable to participate in a face-to-face, online or telephone interview
- Unable to access interpreter for first language
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Exploring the Experiences of Adults Living With Multiple Pre-existing Long-term Conditions and Long COVID to Understand Their Rehabilitation Needs
The goal of this observational study is to learn about the impact of long COVID on people who have multiple (two or more) pre-existing long-term conditions (such as diabetes and asthma). The main question it aims to answer is:
- How does long COVID impact the lives of adults living with multiple pre-existing long-term conditions and what are their rehabilitation needs?
Participants will be asked to:
- Take photos of things they feel represent the impact of long COVID on their day-to-day lives across seven days and,
- Take part in an interview to discuss the impact of long COVID.
Read the detailed description
This qualitative study will involve participants taking photographs (during their usual day-to-day activities), followed by 1:1 semi-structured interviews. Participants will be adults living with multiple pre-existing long-term conditions (LTC) and long COVID or their carers/supporters.
Stage 1: Photographs Participants will be asked to take photographs of things they feel represent or symbolise the impact of long COVID on their day-to-day lives across seven days in advance of the interview.
Stage 2: Interviews Semi-structured 1:1 interviews will be held face-to-face, online or telephone (in accordance with participant preference to optimise inclusivity). The iterative interview topic guide will continue to be informed by patient and public involvement and engagement, evidence (including preceding projects of the PhD), and the participants' photographs. Photographs will be viewed during the interview with participants.
The findings of this qualitative study will be used to inform the adaptation of exercise-based rehabilitation programmes to improve health and well-being which meets the needs of individuals living with multiple pre-existing LTC and long COVID.
- Conditions
- Long COVID, Multiple Chronic Conditions
- Keywords
- COVID-19
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Multiple Chronic Conditions, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiences and perceptions of the impact of long COVID on health and well-being
Participant photographs and 1:1 semi-structured interviews will be used to explore the experiences and perceptions of purposive samples of adults living with multiple pre-existing long-term conditions and long COVID to understand their rehabilitation needs. Photovoice and photo-elicitation will be used in combination with reflexive thematic analysis to support the interpretation process and a more participant led understanding of concepts.
Measured: April - August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachael Dr Evans, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223997
- Sponsor's protocol ID
- 0948
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Experiences of Adults Living With Multiple Pre-existing Long-term Conditions and Long COVID to Understand Their Rehabilitation Needs
- ClinicalTrials.gov ID
- NCT06223997
- Acronym / sponsor ID
- 0948
- Conditions
- Long COVID, Multiple Chronic Conditions
- Keywords
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the impact of long COVID on people who have multiple (two or more) pre-existing long-term conditions (such as diabetes and asthma). The main question it aims to answer is:
- How does long COVID impact the lives of adults living with multiple pre-existing long-term conditions and what are their rehabilitation needs?
Participants will be asked to:
- Take photos of things they feel represent the impact of long COVID on their day-to-day lives across seven days and,
- Take part in an interview to discuss the impact of long COVID.
Detailed description
This qualitative study will involve participants taking photographs (during their usual day-to-day activities), followed by 1:1 semi-structured interviews. Participants will be adults living with multiple pre-existing long-term conditions (LTC) and long COVID or their carers/supporters.
Stage 1: Photographs Participants will be asked to take photographs of things they feel represent or symbolise the impact of long COVID on their day-to-day lives across seven days in advance of the interview.
Stage 2: Interviews Semi-structured 1:1 interviews will be held face-to-face, online or telephone (in accordance with participant preference to optimise inclusivity). The iterative interview topic guide will continue to be informed by patient and public involvement and engagement, evidence (including preceding projects of the PhD), and the participants' photographs. Photographs will be viewed during the interview with participants.
The findings of this qualitative study will be used to inform the adaptation of exercise-based rehabilitation programmes to improve health and well-being which meets the needs of individuals living with multiple pre-existing LTC and long COVID.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be individuals living with multiple (≥2) pre-existing long-term conditions and long COVID or 'post-COVID-19 condition' (in accordance with the World Health Organisation definition) or carer/supporter for someone who is; identified and recruited via University Hospitals of Leicester NHS Trust. Participants will be living in Leicester (UK) and either able to take photographs themselves or have a carer/supporter who is able and willing to do this for them.
Key inclusion criteria (4 listed)
- Adult (≥18 years) living with long COVID (or 'post-COVID-19 condition' in accordance with the World Health Organisation definition) and ≥2 pre-existing long-term conditions or carer/supporter for someone who is
- Living in Leicester (UK)
- Able to take photographs or carer/supporter who is able and willing
- Able and willing to provide informed consent
Key exclusion criteria (3 listed)
- Child (<18 years)
- Unable to participate in a face-to-face, online or telephone interview
- Unable to access interpreter for first language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Experiences and perceptions of the impact of long COVID on health and well-being
Time frame: April - August 2024
Participant photographs and 1:1 semi-structured interviews will be used to explore the experiences and perceptions of purposive samples of adults living with multiple pre-existing long-term conditions and long COVID to understand their rehabilitation needs. Photovoice and photo-elicitation will be used in combination with reflexive thematic analysis to support the interpretation process and a more participant led understanding of concepts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Long COVID
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The Study of Brave-LC LDN Treatment Trial
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Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachael Dr Evans principal investigator
University of Leicester
Questions about this trial
What is this clinical trial studying?
An observational study of Long COVID and Multiple Chronic Conditions, run by University of Leicester.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucy Gardiner (01162583035, longCOVIDLTCstudy@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiences and perceptions of the impact of long COVID on health and well-being (time frame: April - August 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.