ClinicalTrials.gg
Not yet recruitingNCT06223997Updated Feb 14, 2024

The Impact of Long COVID on People Living With Pre-existing LTC

An observational study in Long COVID and Multiple Chronic Conditions, sponsored by University of Leicester. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-14.

Sponsored by University of Leicester · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Long COVID
  • Multiple Chronic Conditions

Keywords

  • COVID-19
03

In context

Post-Acute COVID-19 Syndrome

604 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 201 are open to participants now.

This study's planned enrollment of 20 is below the median of 150 across 173 observational studies indexed under Post-Acute COVID-19 Syndrome.

Browse Post-Acute COVID-19 Syndrome studies →

Lead sponsor

University of Leicester is the lead sponsor of 170 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Child (\<18 years)
  • Unable to participate in a face-to-face, online or telephone interview
  • Unable to access interpreter for first language
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: April - August 2024

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2024; primary completion for Aug 2024, 6 months later.

Of 98 non-industry observational studies under Post-Acute COVID-19 Syndrome, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's planned 6 months is below that.

Counting every sponsor, half of 105 studies reached it within 27 months; a quarter within 14 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2024
First posted
Jan 25, 2024
StartEst.
Feb 2024
Primary completionEst.
Aug 2024
CompletionEst.
Aug 2024
Last update
Feb 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06223997
Responsible party
Sponsor
First posted
Jan 25, 2024
Start date
Feb 2024 (estimated)
Primary completion
Aug 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
Feb 14, 2024

Study contacts

Lucy Gardiner
Contact
longCOVIDLTCstudy@leicester.ac.uk
01162583035
Rachael Dr Evans
principal investigator · University of Leicester

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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