Individuals with experience of long Covid.

Participants will be eligible to take part in the co-design if they are living with or recovered from long Covid (self-identified), are aged 18 years or above at the time of the co-design, an English or Welsh speaker, or have access to someone who can act as a translator. Residents from any part of the UK are eligible. The Participant Information Sheet makes the eligibility criteria clear but no checks will be carried out to ensure participant eligibility With people reporting disbelief and lack of diagnosis from healthcare providers, people with self-identified long Covid will be recruited to ensure dissatisfactory healthcare experiences do not act as a participation barrier. A further requirement will be that participants do not also take part in the later trial of the LISTEN intervention.

Rehabilitation practitioners.

Rehabilitation practitioners will be eligible if they work in community rehabilitation services as allied healthcare professionals, nurses or support workers, have experience of supporting people with long Covid symptoms, or have personal experience of long Covid. For instance, rehabilitation practitioners can contribute their experiences of long Covid from a provider and/or service user perspective. Other healthcare professionals (e.g., medics) will not be recruited due to the community rehabilitation focus of the intervention.

Stage 1: Bringing together people living with or recovered from long Covid and rehabilitation practitioners in separate events (small co-design group meetings).

Initially, we will hold separate co-design group meetings for rehabilitation practitioners, and people living with or recovered from long Covid. Whilst we acknowledge that some of the rehabilitation practitioners will have lived experience of long Covid and people living with / recovered with long Covid may also be rehabilitation practitioners, we make the distinction to emphasise that the two co-design groups will have a slightly different focus. In the two separate groups, we will ask participants to draw, respectively, on: 1) the experience of living with long Covid, and 2) the experience of supporting others, professionally, who are living with long Covid. Separate groups will be hosted to ensure people with long Covid could express their stories without fear of judgment and disbelief from practitioners, and to allow for the development of distinct patient and practitioner priorities.

Ahead of the events, participants will be sent a ‘welcome pack’, which will include a series of questions to guide discussion during the online event, both electronically, by email, and in hard-copy, through the post. This will include a copy of a self-management book for people who have experienced major trauma, stroke or brain injury, as an example of a co-designed resource developed by Bridges self-management [9].

Each online co-design group will include up to eight participants, to ensure all members have the chance to tell their story, to discuss the challenges they faced as people living with long Covid and the solutions they developed to live better with long Covid (and, for some, to recover from the condition). Building on what they have shared and discussed with other group members, and a presentation about the Bridges book, the group will then begin exploring their ideas about, and priorities forthe contents of the self-management resources for people with long Covid. They will also reflect on the main messages for rehabilitation practitioners arising from the group’s discussions.

Group meetings will last up to two hours, including time for a pre-meeting ‘meet and greet’ session, where participants can chat informally, and a break half-way through the meeting. Participants will be reminded that they can take further breaks as needed during the meeting.

A minimum of two people with expertise in co-design will facilitate the meetings, drawing on a variety of strategies to generate ideas from the groups. Group discussions will include access to a virtual white board, break-out rooms and interactive activities to generate discussion. Meetings will be recorded for the purpose of summarising key experiences. A meeting summary will then be sent to all participants and their reflections on the summaries sought, in preparation for the larger mixed co-design group meeting. Those with no internet access or who are uncomfortable with the online medium will be offered the option of contributing to the co-design through a telephone conversation with a member of the study team. Their contribution will then be included within the summaries sent to participants for their feedback. All summaries will be checked for accessibility, following guidance provided by Diversity and Ability.

Stage 2: Bringing together people living with or recovered from long Covid and rehabilitation practitioners in a join event (large co-design group meeting).

Participants from all initial small-group meetings will come together in a large mixed-group meeting of 30–45 people (both practitioners and people living with or recovered from long Covid), also lasting up to two hours and with an informal pre-meeting session and mid-way break. In this session, participants will have the opportunity to share the topics discussed during the initial small group meetings. Feedback on priorities for the LISTEN intervention will be discussed in small breakout rooms to allow each person’s voice to be heard by others. The joint event will be recorded but not the dialogue in breakout rooms. Instead, participants will be invited to give a verbal summary from their breakout room discussions. A final summary will be developed by the study team including the priority list and sent out to all participants for feedback. For participants who do not have internet access or are uncomfortable with the online medium, we will again ask if they wish to contribute by means of a telephone conversation with a member of the study team.

Stage 3: Conducting narrative interviews with people living with or recovered from long Covid.

Interviews will be conducted with up to 15 people living with or recovered from long Covid, selected among participants in previous co-design meetings who have consented to taking part in a filmed interview. The 15 participants will be selected to reflect the diversity of participant characteristics, including symptom type and severity and also where they feel they are in their long Covid ‘journey’. For example, while there may be no singular recovery ‘journey’ or trajectory, stages are likely to include recent development or diagnosis of long Covid, living with and managing the condition for a while, experiencing a relapse, or fully recovered. These interviews will be used to generate content for the LISTEN intervention book in hard-copy and digital form and, in addition, used within practitioner training.

Semi-structured interviews will be guided by an initial opening question encouraging the interviewee to tell their story of living with long Covid, the challenges they encountered and the solutions they developed. Following the opening question, the member of the study team conducting the interview will only use occasional prompts to keep the narrative flowing and on topic (when it is felt appropriate to do so). The interviews will be less than 60 minutes in length and participants will be given the option to do their interview over several separate sessions to help manage fatigue and difficulties with concentration. Participants will also be able to cancel and re-schedule interviews at short notice should fluctuating symptoms prevent participation, and will be sent the interview topics at least one week in advance to allow for any preparation. Each interview will be carried out and recorded using Zoom, then transcribed and anonymised.

Stage 4: Co-design work in small groups focusing either on the contents of the resources or training.

Participants in the earlier co-design meetings will be invited to a further small co-design group meeting of up to two hours, following the format of the previous group meetings, and including both people living with or recovered from long Covid and rehabilitation practitioners. In one meeting participants will work together to refine and finalise the content of the self-management resources. In the other meeting, participants will focus on finalising the training for practitioners. These two groups of up to eight people each will collate of a ‘bank’ of narratives by people living with or recovered from long Covid in filmed and written form, and agree on the content. For participants who do not have internet access or are uncomfortable with the online medium, we will again ask if they wish to contribute by means of a telephone conversation with a member of the study team.

Stage 5: Finalising the resources, training and coaching: The LISTEN intervention.

An interative approach will be used in working with co-design groups to develop the book in hard-copy and digital form, and the training for rehabilitation practitioners.

The book will avoid technical language and will be written through the experiences and words of people living with long Covid. We will work closely with a design company, and Diversity and Ability to ensure the layout and font size is accessible and the sections are easy to navigate. The order and content will be agreed and refined by the research team and the co-design group.

Training for rehabilitation practitioners will draw on existing training methodology developed by Bridges self-management but will be refined to include key examples, preferences and content generated from the co-design stages. Trained rehabilitation practitioners will be supported to deliver the intervention by the Bridges self-management team according to key fidelity markers. We anticipate this will comprise one-to-one personalised self-management support delivered remotely over six sessions within a 10-week timeframe. The fidelity of intervention delivery will be evaluated as part of an extensive process evaluation within the definitive trial. Practitioners delivering the intervention will become a community of practice with regular coaching support from the Bridges team and a clinical psychologist, and access to podcasts, webinars and prompt sheets.

Standard 1 inclusive opportunities.

The inclusive opportunities standard refers to the provision of public involvement opportunities which are accessible and reach people and groups according to research needs.

To involve people living with long Covid and rehabilitation practitioners from diverse backgrounds and seldom heard groups, we will work with Diversity and Ability as previously described. We have contacted long Covid support groups such as Covid:aid [30], and Long Covid Support [31], and other health and inclusion focused organisations such as Health Watch England [32] and National Voices [33] in order to reach people specifically concerned by this research. Throughout the process we will continue to engage with the long Covid community in various ways.

We will ensure opportunities for involvement are accessible by providing multiple options and supportive guidance, including guidance on accessing and joining the co-design meetings. Where internet accessibility may act as a barrier, alternatives to online meetings will be offered (e.g., talking to a researcher on the phone). To develop rapport and enhance participant comfort, short informal discussions will be offered to potential participants prior to joining the co-design meetings. Diversity and Ability will help access interpreters for people who would like to participate, but do not have English as their first language. Honoraria will be provided to members of the public who work with us during the co-design study.

We will use a range of approaches to introduce and update the study activities, including social media (e.g., Twitter) and a blog. The blog and the twitter page will invite comments and feedback from the public on the study.

Standard 2 working together.

Working together refers to a way of working which values all contributions, and that builds and sustains mutually respectful and productive relationships.

To work with the public in the design of the research, we set up a PPIE advisory group of people living with long Covid. The group will meet every two months during the co-design study, and quarterly thereafter until the end of the LISTEN project (August 2023). The group will be facilitated jointly by the LISTEN Chief Investigator and a healthcare professional living with long Covid.

We will also work together with the public during the co-design stages. We will draw on the Bridges self-management methodology which prioritises diverse voices, needs and experiences of individuals and families to (a) agree key design areas and set priorities; (b) initiate the co-design of training materials, digital resources /paper-based workbook; (c) co-design content, prompts and brief guides for delivering the intervention; and (d) co-deliver training.

Several strategies will be employed to ensure we work together in a mutually respectful and productive way. Firstly, co-design activities will be jointly facilitated by the researchers and the Bridges team. Two or three individuals with experience of generating ideas and solutions from groups will be present, supported by Diversity and Ability. Participants will be encouraged to share as little or as much as they wish. At the outset of the activities, the research team will describe their roles and emphasise their desire to listen and work with people to achieve a mutual goal.

Secondly, provisions will be made to manage the physical and cognitive symptoms of long Covid and allow participants to contribute as fully as possible. We willinclude breaks within sessions, opportunities to turn cameras off, encouragement to use the chat and response functions instead of verbal interaction, and sending out summaries after each session to allow for further reflection at a time that suits participants.

Feedback from the co-design participants will directly inform the development of self-management resources and the practitioner training. The process will be iterative in direct response to participant suggestions logged during and after meetings, and should contradictions arise, these will be discussed until a mutual decision is reached. Feedback from the PPIE group meetings will be summarised and circulated for further reflection. Ideas to take forward will be taken to research team meetings, and if any concerns are raised, these will be logged and reported to the study chief investigators.

Finally, all PPIE group members will be remunerated for their time attending meetings according to guidance published by NIHR [34], and engaging in any additional activities (e.g., meeting preparation, providing feedback on materials). Co-design participants will receive vouchers for their participation in different stages of the co-design process.

Standard 3 support and learning.

The third standard relates to the promotion and offer of support and learning opportunities that build confidence and skills for public involvement in research.

Using our links with the PPIE leads of the NIHR ARC South London, we will offer support and training to all members of the PPI advisory group, we will offer support and training to all members of the PPIE advisory group. The extent of training required and the mode of delivery will be decided through discussion during our first group meetings. We will also have access to support for our PPIE group from the Centre for Public Engagement in Kingston University’s Faculty of Health and Social Care.

During co-design activities, people living with long Covid and rehabilitation practitioners will be offered the opportunity to design and deliver previous meeting summary presentations. The research team will offer support where requested to enhance participants’ skills and confidence to create and deliver short presentations, and to promote better engagement in the research.

Standard 4 communications.

This standard encourages research teams to communicate in ways that are relevant, accessible, well-timed and effective.

To ensure that communication is relevant and accessible, we will work closely with Diversity and Ability who will review our communications, recruitment and activity materials for accessibility, and guide our overall approach. In recognition of the physical and mental symptoms of long Covid, co-design activities will not occur more than once per week. Individuals involved will be contacted via email about the co-design activities, and materials for the activities will be sent in advance to allow for preparation.

Standard 5 impact.

Impact refers to the improvement and difference that public involvement makes to research

The involvement of the public in LISTEN, and particularly in the co-design phase, is integral and without it, the study would not take place. The LISTEN PPIE advisory group will guide us throughout the study and provide input into the co-design of the LISTEN intervention. Note-taking during meetings and keeping records of meeting discussions will allow for the monitoring of public involvement in the overall study and facilitate periodic reviews of public involvement. Co-design meeting summaries will enable us to track how ideas were proposed in the small co-design activities, developed in future activities, and represented in the final intervention.

We will include a discussion of the difference that public involvement makes to research as part of the LISTEN management group meetings, and the involvement of the public in the LISTEN study will be made explicit in any research outputs such as reports and publications, though individual identities will be kept confidential. At the end of the co-design phase, we will ask people with long Covid and rehabilitation practitioners to share their experiences of research involvement and describe how they feel that involvement impacted them personally.

We will co-determine outcome measures to assess the impact of the PPIE for all six standards across the relevant stages of the trial.

Standard 6 governance.

Governance refers to the involvement of the public in research management, regulation, leadership and decision-making. We will provide various PPIE opportunities in the formal research governance of the LISTEN project. One PPIE representative has been named as a co-applicant on the project funding application. A further PPIE representative will be included in the project management group and their active participation encouraged. This group will meet monthly to discuss key management issues and monitor project progress against stipulated milestones.

The LISTEN PPIE advisory group will provide further involvement opportunities. When the co-design phase of LISTEN ends, participants in the co-design will be invited to join the LISTEN trial PPIE advisory group, allowing the PPIE group to expand, benefit from more voices and experiences, while also allowing practitioners and people with long Covid to get involved in research management and decision-making.