Long COVID optimal health program (LC-OHP)
| ISRCTN | ISRCTN38746119 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38746119 |
| IRAS number | 304234 |
| Secondary identifying numbers | IRAS 304234, CPMS 50608 |
- Submission date
- 14/09/2021
- Registration date
- 08/10/2021
- Last edited
- 19/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
People with long COVID have various symptoms lasting 12 weeks or more beyond the acute infection. The most common symptoms are fatigue, brain fog, and increased risk for developing anxiety and/or depression, all of which significantly affect an individual's quality of life.
As COVID-19 is still a new viral infection, there are lots of unknowns surrounding it and no standard treatment is yet available to either stop long COVID developing or to help with all the symptoms people are living with. Rather, those treatments given are dependent on each presenting symptom, so while people may get help with their fatigue, they may have to go elsewhere to get support to manage their ‘brain fog’. The NHS recommends that people with long COVID should receive care that helps with all their symptoms (not just one at a time), including support to mitigate their fatigue, improve mental health and encourage self-management.
The Integrated Care Academy at the University of Suffolk is leading a research project on long COVID. The project is funded by the Mental Health Alliance (East Suffolk, West Suffolk and North East Essex) Board. It aims to provide people with long COVID with better support to improve their quality of life by using the Long COVID Optimal Health Program LC-OHP). This is a program that is delivered in weekly sessions and works to support people with their symptoms, such as helping to reduce fatigue and brain fog, as well as improving physical activities and mental wellbeing.
Who can participate?
Persons aged 18 years old and above and who have been experiencing symptoms of long COVID for 12 weeks or more following the start of symptoms.
What does the study involve?
People participating will be randomly divided into two groups, one will receive the LC-OHP and the other group will receive usual care. This will help us identify whether the program is effective for long COVID.
For those that receive the LC-OHP, we will deliver this in five sessions (one session per week) and an additional booster session three months after the fifth session. We will provide participants with a booklet that summarises the weekly sessions and will give them access to an online version as well. We will deliver the sessions either on a one-to-one basis or in groups, depending on participants’ preferences. We will also deliver the sessions virtually or by phone at a convenient time.
For those that do not receive the LC-OHP, they will still receive all care that they have been receiving either at the hospital clinic or through their GP.
To further understand people’s feelings and challenges in living with long COVID and to see if the LC-OHP is working, we will also be asking both groups to complete a number of short questionnaires at the start, middle and end of the project. These will take less than 15 minutes in total to complete. We will also interview some participants who received the LC-OHP to explore their views of the program. We also plan to interview participants who decide to withdraw from the LC-OHP (if any), to identify whether we could do anything to improve the program for other people.
What are the possible benefits and risks of participating?
We do not anticipate any risks associated with the LC-OHP, however, there is a possibility of fatigue from attending the program’s sessions. To prevent fatigue, we will provide breaks and rest periods, or if necessary, end the session and complete it at another time at the participant’s request. We will support to participants as needed.
While we haven’t used the OHP for people with long COVID, it has been really successful in other chronic medical conditions, such as asthma, diabetes, stroke and chronic kidney disease. We are anticipating that the LC-OHP will improve the symptoms, physical activity and mental wellbeing of participants with long COVID. Also, the study will help in identifying which types of support might help people in managing their long COVID.
Where is the study run from?
University of Suffolk (UK)
When is the study starting and how long is it expected to run for?
September 2021 to May 2023
Who is funding the study?
Mental Health Alliance (East Suffolk, West Suffolk and North East Essex) Board (UK)
Who is the main contact?
Dr Hiyam Al-Jabr, h.al-jabr@uos.ac.uk
Contact information
Scientific
University of Suffolk
Integrated Care Academy
Waterfront Building
19 Neptune Quay
Ipswich
IP4 1QJ
United Kingdom
 ORCID ID |
0000-0002-4038-3996 |
|---|---|
| Phone | +44 (0)1473 338845 |
| h.al-jabr@uos.ac.uk |
Scientific
Chief Investigator
Integrated Care Academy
University of Suffolk
Waterfront Building
19 Neptune Quay
Ipswich
IP4 1QJ
United Kingdom
| ORCID ID |
0000-0003-1324-2933 |
|---|---|
| c.ski@uos.ac.uk |
Scientific
Integrated Care Academy
University of Suffolk
Waterfront Building
19 Neptune Quay
Ipswich
IP4 1QJ
United Kingdom
| ORCID ID |
0000-0002-2136-735X |
|---|---|
| Phone | +44 (0)1473 338291 |
| k.windle@uos.ac.uk |
Study information
| Study design | Pilot single blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Long COVID Optimal Health Program (LC-OHP) to enhance psychological and physical health: a feasibility randomised controlled trial |
| Study acronym | LC-OHP |
| Study hypothesis | The LC-OHP program will improve the physical and psychosocial wellbeing of people with long COVID. |
| Ethics approval(s) | 1. Approved 05/10/2021, University of Suffolk ethics committee (Waterfront Building, 19 Neptune Quay, Ipswich IP4 1QJ, UK; +44 (0)1473 338330, s.raychaudhuri@uos.ac.uk), ref: RETH21/004 2. Approved 01/11/2021, Bristol Research Ethics Committee Centre (Ground Floor, Temple Quay House, Bristol Research Ethics Committee Centre, BS1 6PN, UK; +44 (0)207 104 8029; approvals@hra.nhs.uk), REC ref: 21/SW/0136 |
| Condition | Patients with long COVID |
| Intervention | Randomisation: Participants will be randomised following the receipt of baseline data to either intervention or control group via a computer-generated block randomization. To avoid bias, an independent person will carry out participant randomisation. Due to the nature and length of the intervention, it is not possible to blind either the researcher nor the participant to the treatment allocation. Control group: Standard care Participants allocated to the control group will receive that care usually provided to patients with long COVID. No fixed standard care is yet available and patients are managed symptomatically while following NICE guidelines. Intervention group: LC-OHP The long COVID OHP will be provided to participants allocated in the intervention group after the receipt of their baseline data. The OHP is a person-centred model and focuses on health as defined by consumers. It aims to support people with mental or physical illness by using a multidisciplinary collaborative therapy and self-efficacy intervention. The program addresses psychological and physical dimensions of health and is flexible to be delivered by a range of practitioners. It can also be delivered at all stages of the care trajectory; in inpatient and outpatient settings, at homes, or by video conferencing, and to groups or to individuals consumers. In this trial, recognising that fatigue is a core component, the OHP for long COVID will be delivered in five sequential sessions. The program’s key elements include goal setting, problem solving, identifying social supports and developing plans to cope with daily stressors, and responding to an episode of illness Delivery of the five sessions will be weekly, with the first session held after collecting baseline data and the last completed prior to collecting data at three months. An additional booster session will be held three months after the last session and will target reviewing health plans and reflecting on achievements made towards health-related goals. Sessions will be held either in a 1:1 encounter with the facilitator, or in groups (a maximum of eight participants per group), or using a mixture of both, depending on participants’ preferences. The 1:1 sessions will last up to one hour, with breaks provided upon participant’s request, and if necessary, the session can be completed at another time. Group sessions will last up to 90 min and breaks will be provided upon request. Sessions will be held online (using a convenient platform such as Zoom, Skype or Microsoft Teams). Those who do not have access to online facilities will be given the option to have the sessions delivered by telephone. Sessions will be audio recorded to be checked by another member of the research team to confirm fidelity with delivering the program. |
| Intervention type | Behavioural |
| Primary outcome measure | Feasibility and acceptability measured by: 1. Recruitment and retention rates measured by identifying the number of participants taking part in the study (from start to end) and number of participants who withdraw from the study at any point. 2. Acceptability and satisfaction of the LC-OHP measured by: 2.1. Conducting a telephone interview with a sample of participants in the intervention group at the end of the trial 2.2. Asking participants in the intervention group to complete the Course Experience Questionnaire (CEQ) at the end of the trial Participants who decide to withdraw from the trial will also be invited to a short interview to assess their views of the LC-OHP and any changes that they may wish to suggest. Interviews will be held as soon after they withdraw 3. Acceptability of secondary outcome measures measured using telephone interview with a sample of participants in the intervention group at the end of the trial |
| Secondary outcome measures | Measured at baseline, and at 3 and 6 months post-randomisation: 1. Depression (Patient Health Questionnaire (PHQ-9)) 2. Anxiety (The generalised anxiety disorder assessment (GAD-7)) 3. Self-efficacy (General Self-Efficacy Scale (GSE)) 4. Quality of life (EQ-5D-5L questionnaire) 5. Fatigue Assessment Scale (FAS) |
| Overall study start date | 14/09/2021 |
| Overall study end date | 20/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Participant inclusion criteria | 1. Adult (18+ years with no upper age limit). 2. COVID-19 infection confirmed through PCR testing or clinical diagnosis from GP. 3. Experiencing post-COVID-19 syndrome (as defined by NICE 2020) 12 weeks or more following onset of symptoms / confirmed through testing. 4. Able to participate in telephone interview in English language (or with accommodated adjustments). 5. Able to consent to participate in study. |
| Participant exclusion criteria | 1. Children and young adults (17 years and under). 2. Unable to consent to participate in study, despite reasonable adjustments being implemented. 3. Unable to participate in telephone interview in English language, where the research team have been unable to make adjustments to enable their participation. |
| Recruitment start date | 23/11/2021 |
| Recruitment end date | 28/10/2022 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centre
19 Neptune Quay
Ipswich
IP4 1QJ
United Kingdom
Sponsor information
University/education
Waterfront Building
19 Neptune Quay
Ipswich
IP4 1QJ
England
United Kingdom
| Phone | +44 (0)1473 338656 |
|---|---|
| a.tocca@uos.ac.uk | |
| Website | http://www.ucs.ac.uk/home.aspx |
"ROR" |
https://ror.org/01cy0sz82 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in: - High-impact peer-reviewed journals - Abstracts submission to national and international conferences - Social media including Twitter, YouTube, LinkedIn |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol (preprint) | 21/01/2022 | 18/03/2022 | No | No | |
| Protocol article | 24/02/2022 | 26/04/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
19/05/2023: The following changes have been made:
1. The total final enrolment was added.
2. Northern Ireland, Scotland and Wales were added as countries of recruitment.
3. The intention to publish date has been changed from 31/10/2023 to 31/10/2024.
06/02/2023: The overall trial end date was changed from 28/02/2023 to 20/05/2023 and the plain English summary has been updated to reflect this change.
18/10/2022: The recruitment end date was changed from 18/10/2022 to 28/10/2022.
30/09/2022: The recruitment end date was changed from 30/09/2022 to 18/10/2022.
19/07/2022: The recruitment end date was changed from 31/07/2022 to 30/09/2022.
26/04/2022: Publication reference added.
23/03/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/03/2022 to 31/07/2022.
2. The overall trial end date has been changed from 31/10/2022 to 28/02/2023 and the plain English summary has been updated to reflect this change.
18/03/2022: Preprint link added.
16/11/2021: The recruitment start date has been changed from 15/11/2021 to 23/11/2021.
09/11/2021: Ethics approval and contact details added.
01/11/2021: The CPMS number was added.
21/09/2021: Trial's existence confirmed by South West - Central Bristol Research Ethics Committee.
