NCT06223997

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 14, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

January 24, 2024

Last Update Submit

February 11, 2024

Conditions

Keywords

COVID-19

Outcome Measures

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.

    April - August 2024

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Post-Acute COVID-19 SyndromeMultiple Chronic ConditionsCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rachael Dr Evans

    University of Leicester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2024

First Posted

January 25, 2024

Study Start

February 1, 2024

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

February 14, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share