Reducing fatigue in Long COVID-19: A feasibility study of a self-help intervention to reduce fatigue-related symptoms among patients in general practice
| ISRCTN | ISRCTN99840264 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99840264 |
| IRAS number | 291940 |
| Secondary identifying numbers | IRAS 291940, Sponsor 21OTHER01-S, CPMS 51098 |
- Submission date
- 03/08/2022
- Registration date
- 09/08/2022
- Last edited
- 31/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
We know many people who have COVID-19 can feel fatigued and that this doesn't always go away. Our study aims to test a treatment already used with patients who have chronic fatigue syndrome (ME/CFS) to see if it could help.
Who can participate?
Adults aged 18 years or over can participate, who received a positive COVID test between July 2020 and February 2022. Entry into this Phase 2 intervention trial is via initial screening through our original Phase 1 online survey. Invitations to this Phase 1 survey are sent by email or text to patients who volunteered to join the Research for the Future database OR to patients with a GP in Greater Manchester who invite them to take part.
What does the study involve?
One of our research practitioners will telephone or email you if you are eligible and have provided your contact details when you completed the Phase 1 survey. if you agree to take part they will go through a consent form over the phone or by email with you and answer any questions you might have, You will then be allocated at random to either receive the intervention treatment immediately or 12 weeks later. The intervention kits will be sent through the post to you at home.
You will be asked to follow a treatment plan over the next 12 weeks and have a tick list to monitor this. You will be provided with all you need to do this: a long handled massager, massage oil, hot water bottle, cold gel pack and instructions plus a link to video demonstration and a contact for our patient liaison advocate who can help answer any questions.
After 12 weeks all participants will be asked to complete the same short online survey.
Those without intervention packs will then receive theirs through the post.
You can choose to continue to use the pack if you wish after the initial 12 weeks.
Some participants will be asked to take part in an interview over the phone about their experiences of using the treatment.
We ask everyone to repeat the short online survey again at 24 weeks.
What are the possible benefits and risks of participating?
We hope using the treatment will help your fatigue and this has been used successfully for a number of years in people with fatigue. This study reduces the need to attend centres for treatment and we hope this along with the short survey will help reduce participant burden.
The treatment takes around 30 minutes each day to complete though can be used more if you wish. In order to benefit from the hot / cold therapy we recommend wrapping the hot water bottle and gel cold packs in cloths to avoid any burning of the skin.
Where is the study run from?
The study is run from Salford Royal Hospital (UK) with colleagues from The University of Manchester and The Perrin Clinic also involved in the study.
Who is funding the study?
The study is funded by Fund into Osteopathic Research Into ME (FORME) (UK) a charity to help patients with chronic fatigue (ME/CFS) who also have an interest in underlying causes of fatigue and Long COVID.
When is the study starting and how long is it expected to run for?
March 2021 to November 2023
Who is the main study contact?
Dr Lisa Riste
lisa.riste@manchester.ac.uk
Contact information
Scientific
Greater Manchester Patient Safety Translational Research Centre
Division of Pharmacy and Optometry
School of Health Sciences
Room 1.134, 1st Floor Stopford Building
The University of Manchester
Oxford Road
Manchester
M13 9PT
United Kingdom
 ORCID ID |
0000-0003-2606-0717 |
|---|---|
| Phone | +44 161-275-8357 |
| lisa.riste@manchester.ac.uk |
Principal Investigator
Salford Royal NHS Foundation Trust Hospital
Stott Lane
Salford
Manchester
M6 8HD
United Kingdom
| ORCID ID |
0000-0002-9537-4050 |
|---|---|
| Phone | +44 7470 532162 |
| adrian.heald@nca.nhs.uk |
Public
Greater Manchester Patient Safety Translational Research Centre
Division of Pharmacy and Optometry
School of Health Sciences
Room 1.134, 1st Floor Stopford Building
The University of Manchester
Oxford Road
Manchester
M13 9PT
United Kingdom
| Phone | +44 7903133719 |
|---|---|
| lisa.riste@manchester.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | 42175 PIS V0.2 10Dec2021.pdf |
| Scientific title | In people with Long COVID related fatigue, is there a difference between participants using self-help lymphatic drainage vs. no intervention on fatigue (assessed using Chalder Fatigue Questionnaire (CFQ) score) at 12 weeks? |
| Study objectives | Self-help intervention techniques that promote lymphatic drainage will help reduce fatigue in patients with Long COVID more than those in the wait-lit control arm at 12 weeks. |
| Ethics approval(s) | Approved 13/01/2022, London - Chelsea Research Ethics Committee London Centre (2 Redman Place, Stratford, London, E20 1JQ, UK; +44 (0)207 104 8029; chelsea.rec@hra.nhs.uk), ref: 21/LO/0809 |
| Health condition(s) or problem(s) studied | Fatigue symptoms following Long COVID |
| Intervention | Following consent over the telephone by one of our research practitioners, participants will be randomised into the trial using sealed envelope (TM) 1:1 intervention to wait-list control. Randomisation will be stratified by gender and by recruitment site (RftF vs FARSITE GP invitation). Eligible participants will be allocated at random (1:1) in blocks of size 4, 6 or 8 (chosen at random and in equal numbers) to: Intervention: This group will receive an intervention pack containing; patient instructions and online video link, a long handled massager and massage oil, hot water bottle and gel pack for contract bathing and a tick sheet to monitor recommended exercises, Wait-list control group: Will receive the same pack 12 weeks after randomisation. Both groups will be asked to complete follow-up online surveys at 3 months (12 weeks) and 6 months (24 weeks) post RDZ. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. The recruitment rate into our Phase 2 intervention will be recorded as the number of eligible participants who consented to participate in the study over the 4 month recruitment period. 2. The attrition rate in our Phase 2 intervention will be recorded as the number of eligible participants who consented to participate in the study but had not completed final 24 week follow-up measures. |
| Secondary outcome measures | 1. Fatigue is measured using Chalder Fatigue Questionnaire (with participants completing online questionnaire using scoring 0,1,2,3) at 0, 12 and 24 weeks. 2. Physical functioning is measured using SF-12 at 0,12 and 24 weeks (online questionnaire) at 0, 12 and 24 weeks. 3. Quality of life is measured using EQ-5D at 0,12 and 24 weeks (online questionnaire) at 0, 12 and 24 weeks. |
| Overall study start date | 12/03/2021 |
| Completion date | 30/11/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Adult aged 18 years or over 2. Tested positive for COVID (between July 2020 and February 2022) 3. Scored of 4 or more on Chalder Fatigue Questionnaire scored bimodally (0,0,1,1) |
| Key exclusion criteria | 1. Less than 18 years 2. Current or previous ME/CFS diagnosis 3. Current end-stage heart failure, cancer, sleep apnoea (or other major sleep disorders) 4. Major mental health diagnoses ( eg. schizophrenia) 5. Pregnant and lactating women 6. Care home residents 7. Dementia |
| Date of first enrolment | 01/08/2022 |
| Date of final enrolment | 31/05/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Stott Lane
Salford
M6 8HD
United Kingdom
Sponsor information
Hospital/treatment centre
Directorate Research & Innovation
1st Floor Summerfield House
544 Eccles New Road
Salford
M5 5AP
England
United Kingdom
| Phone | +44 161 206-5235 |
|---|---|
| steve.woby@nca.nhs.uk | |
| Website | https://www.northerncarealliance.nhs.uk/ |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 31/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | We will aim to have research outputs in the form of original research articles published in Open Access peer review journals and will seek to raise the profile of our work at conference presentations. All the study team will be invited to participate in the writing, reviewing and editing of papers and will conform to guidance issues by IJCME. Results of the study will be disseminated by the Northern Care Alliance NHS Foundation Trust via their website: https://www.reserchforthefuture.org, newsletters and social media. This will ensure that volunteers who have participated in this research have access to the study findings |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. The database will be available as locked-read only CSV spreadsheet which will be uploaded alongside the manuscript submitted for publication. This will allow other researchers to access our feasibility data and show openness and transparency in our work. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 0.2 | 10/12/2021 | 09/08/2022 | No | Yes |
| Protocol file | version 0.2 | 10/12/2021 | 09/08/2022 | No | No |
| HRA research summary | 26/07/2023 | No | No |
Additional files
Editorial Notes
31/05/2023: The following changes were made to the study record and plain English summary was updated to reflect these changes:
1. The total final enrolment was added.
2. The overall study end date was changed from 31/12/2023 to 30/11/2023.
13/12/2022: The following changes were made to the study record:
1. The overall study end date was changed from 30/06/2023 to 31/12/2023.
2. The recruitment end date was changed from 31/12/2022 to 31/05/2023.
3. The plain English summary was updated to reflect these changes.
05/09/2022: Internal review.
09/08/2022: Trial's existence confirmed by NHS HRA.
