Exploring the impact on patients with lupus and related autoimmune diseases of peer support, relationships with clinicians and COVID-19 changes to care

Plain English Summary

Background and study aims
Research shows that peer support is very important to many patients with lupus and similar autoimmune diseases. Researchers are therefore looking to see if being in small email support groups with other people with the same diseases is an acceptable and helpful form of peer support.
They are also looking for patients to help in deciding what they would like researched in more detail, including helping design questionnaires for patients and doctors; the responses to which should help to identify common patient experiences and develop proposals for improving care and support.
Previous studies and current work with lupus and related autoimmune diseases patients found a need for more support with quality of life, mental health and coping with a long-term difficult condition. There is also more research needed on the impact on patient mental health from the often-lengthy diagnostic delays, misdiagnoses and feelings of a lack of support.
The perception of poor care on the diagnostic journey, especially for the many who report feeling their symptoms were disbelieved, can have a continued influence on a patient’s mental health and behaviour. It can therefore damage both mental and physical health, long after the correct diagnosis. Insecurity, fear of rejection and physician’s disbelief were widely reported by these patients in earlier studies to be always present even in later positive medical relationships.
Despite the WHO action plan for chronic disease management encouraging governments to provide education, incentives and tools for patients to manage their own diseases, many patients with lupus report there is limited help with self-management education from doctors, thus often relying on peers in online forums and Facebook groups for knowledge transfer and emotional support. Peer support from those who experience the same challenges of living with the same chronic health condition is increasingly being researched in terms of measuring health outcomes, empowerment, mental health and improved quality of life.
The WHO also recognises the importance of mental wellbeing as an important part of health. Studies have shown varied success from peer support initiatives across different disease types. This study will measure the impact of small group peer support on mental wellbeing. The large-scale questionnaire will determine the current state of mental wellbeing and perceptions of support, in a significant proportion of patients with systemic autoimmune rheumatic diseases in the UK.
The main aims of the study are:
1. To explore whether patients find it acceptable and helpful to receive and give peer support by small group email.
2. To measure the impact of peer support and research involvement on the mental health, wellbeing, self-esteem and disease acceptance of patients with lupus and systemic autoimmune rheumatic diseases.
3. To empower patients and improve research quality and by involving them in research into their own disease; generating research questions and research materials that are relevant to their priorities, needs and experiences.
4. To investigate key factors in effects of the disease and patient-physician interactions before and after diagnosis on patient behaviour, mental health/ wellbeing and disease acceptance.
5. To compare lupus and related disease patients’ wellbeing, mental health and perception of medical care with patients with RA, fibromyalgia and healthy controls.
Added 30/03/2021 due to impact of pandemic during data collection:
6. To investigate key factors in effects of the disease and patient-physician interactions pre and post diagnosis on patient behaviour, mental health/wellbeing and disease acceptance
7. To examine the impact of COVID-19 on medical care, relationships, behaviour and wellbeing
8. To examine the impact of COVID-19 on medical care, relationships, behaviour and wellbeing

Who can participate?
Patients aged 18 or over, resident in the UK, with SLE (lupus), UCTD (undifferentiated connective tissue disease), Sjögren’s syndrome, discoid/cutaneous lupus or MCTD (mixed connective tissue disease)/ overlap disease. Additional participants for the questionnaire study include those with RA (rheumatoid arthritis) or fibromyalgia, resident in UK and aged 18 or over. Healthy controls must be resident in UK, aged 18 or over, and have no significant illness.

What does the study involve?
The study will involve completing a questionnaire about the patient’s disease, wellbeing and feelings. A computer programme will then randomly allocate everyone into three equal groups, which will be labelled A, B and C. Each main group will contain approximately 60 people and be divided into smaller support groups for groups A and B, with Group C being the control group. Group A and B will be divided into small email support groups of 6 people with group A also given research questions (e.g. please discuss in your group what you think are the most important things for rheumatologists to ask in clinic appointments) to discuss and feedback to the researchers every 1-2 weeks. Group C will not be put into support groups initially as it will be the control group (for comparison). However, in order to ensure everyone has the chance of joining an email support group, everyone in Group C will be given the opportunity to be put in an email support group after the first four months of the study if they wish. People in all three groups will receive another questionnaire about their health, feelings and experiences at the end of the study (four months) and after 12 months. The questionnaires designed with help from group A will be sent to LUPUS UK members and clinic patients and physicians.

What are the possible benefits and risks of participating?
Forming a small group with other patients may be of benefit in providing a deeper level of understanding and support than can easily happen with friends and family without the disease. A small group communicating privately may be more personal and comfortable for many people in addition to the support offered by larger public online forums. Being involved in helping with research into their own disease may be empowering and help to improve communication and medical support in the future.

The researchers do not foresee any direct risks to physical health from participating in this study. For those who are randomly allocated to groups A or B, there are small possible risks to consider. It is hoped that discussing experiences will be helpful, but some people may find some discussions about health difficulties and medical experiences distressing. The only rule of the groups is that everyone be kind and supportive. It is most likely that this will be the case and anyone not following this rule will be asked to leave the group. There is a very small risk of unwanted further contact from group members if they decide to withdraw or anyone has been withdrawn due to not following the rules of being kind and supportive.

Where is the study run from?
The Institute of Public Health (IPH) at the University of Cambridge (UK)

When is the study starting and how long is it expected to run for?
March 2020 to April 2021

Who is funding the study?
LUPUS UK

Who is the main contact?
Melanie Sloan
mas229@medschl.cam.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

University of Cambridge
University/education

Institute of Public Health
Forvie Site
Robinson way
Cambridge
CM23 4GH
England
United Kingdom

Phone	+44 (0)7975799052
Email	mas229@medschl.cam.ac.uk
Website	http://www.cam.ac.uk/
"ROR"	https://ror.org/013meh722

Funders

Funder type

Charity

Results and Publications

Study outputs

Additional files

ISRCTN14966097_PROTOCOL_V1_02Nov2019.pdf

uploaded 28/02/2020

Editorial Notes

28/03/2023: Publication references added.
10/01/2022: Publication reference added.
30/03/2021: The following changes were made to the trial record:
1. The study hypothesis, interventions, secondary outcome measures and plain English summary were updated.
2. The public title was changed from 'Exploring whether patients with lupus and related autoimmune diseases find small group peer email support, and involvement in research, influences their wellbeing' to 'Exploring the impact on patients with lupus and related autoimmune diseases of peer support, relationships with clinicians and COVID-19 changes to care'
3. The scientific title was changed from 'Acceptability, feasibility, and impact of peer support email groups and involvement in research, in patients with systemic autoimmune rheumatic diseases' to 'Investigating the impacts of peer support, patient-physician interactions and changes in care due to COVID-19, on the healthcare behaviour, satisfaction with care and mental health/ wellbeing in patients with SLE and other systemic rheumatic diseases.'
4. The overall trial start date was changed from 01/11/2020 to 01/03/2020.
5. Total final enrolment number added.
28/02/2020: Uploaded protocol (not peer reviewed) as an additional file.
27/02/2020: Trial's existence confirmed by Cambridge Psychology Research Ethics Committee.