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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06223997
Other study ID # 0948
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 2024
Est. completion date August 2024

Study information

Verified date January 2024
Source University of Leicester
Contact Lucy Gardiner
Phone 01162583035
Email longCOVIDLTCstudy@leicester.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 informed consent Exclusion Criteria: - Child (<18 years) - Unable to participate in a face-to-face, online or telephone interview - Unable to access interpreter for first language

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Leicester

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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