Determining the feasibility and acceptability of delivering HEADS: UP, a psychoeducational intervention for self-management of depression and anxiety symptoms post-stroke, face-to-face and online

Introduction: Depression and anxiety are prevalent after stroke, persist long-term, and are associated with poor outcomes, including lack of engagement with rehabilitation. Long-term psychological support is a recognised unmet need and a research priority. In previous work with people affected by stroke we co-developed a stroke-specific psychoeducational self-management intervention HEADS: UP, an adaptation of a Mindfulness Based Stress Reduction course. The work reported here aimed to test feasibility and acceptability of HEADS: UP (NCT03956693). Method(s): We recruited stroke survivors (SS) >=3 months post-stroke, with symptoms of mood disorder (Hospital Anxiety and Depression Scale >=8), to participate in one of two non-randomised feasibility studies. Participants could 'enrol' a family member/'other', if desired. Study 1 tested face-to-face delivery of HEADS: UP;data informed optimisation and adaptation of research processes and the intervention. In response to COVID 19, Study 2 tested HEADS: UP Online. Quantitative data (demographics;mood and quality of life outcomes measures (OMs)) and qualitative data were collected pre-/post-intervention. Both studies received ethical approval. Result(s): STUDY 1: SS n=13;aged 63.3 (mean). Feasibility: Completion of paper-based OMs post-intervention n=6 (46.2%);intervention attendance 6.2/9 (median). Acceptability: I find myself . . . on the bus doing [mindfulness]! I realise I am actually doing it! STUDY 2: SS n=9;aged 54.2 (mean). Feasibility: Completion of online OMs: n=9 (100%) post-intervention;intervention attendance: 8.6/9 sessions. Acceptability: I was apprehensive . . . I wasn't sure you could do mindfulness over Zoom . . . but it has worked really, really well Conclusion(s): Stroke survivors found a stroke-specific psychoeducational self-management intervention, HEADS: UP, feasible and acceptable.

Using social media to recruit stroke survivors to the HEADS: UP Online randomised control trial, a stroke-specific psychological self-management intervention: reflections and lessons learned

Introduction: Social media has emerged as a useful and potentially costeffective recruitment route for clinical trials particularly during the COVID-19 pandemic. This paper presents recruitment results and lessons learned from using social media for recruitment to the HEADS: UP Helping Ease Anxiety and Depression after Stroke Online randomised control trial. Method(s): We recruited UK-based community-dwelling stroke survivors with self-reported anxiety and depression. Our recruitment strategy included community networks and social media platforms. Result(s): Recruitment over 22 weeks resulted in 120 leads (5.5/week), with social media, primarily Facebook and Twitter, contributing 38 leads (31.7%;1.7/week). We enrolled 64 participants (female n=36 (56.3%), mean age 56.3 yrs, SD=11.2 ), with 28 (43.8%;female n=15 (53.6%), mean age 53.0 yrs, SD=11.3) recruited through social media. Facebook generated 21 (75%) of 28 social media participants, with Twitter contributing 8 (28.6%), including one participant from both Facebook and Twitter (3.6%). Facebook allowed for recruitment from stroke community groups and contact with key group members who posted regularly on our behalf, aiding credibility. Twitter provided the opportunity to recruit without gatekeepers, but required considerable researcher time and effort spent networking (i.e. Following, Liking, requesting Retweets) and developing new content to post, which stretched our limited resources. Conclusion(s): Social media was an effective, integral strategy for recruitment. However, substantial resources were required to develop content and manage our online presence. Future research could benefit from costing researcher time into funding applications and investing time in identifying and making contacts within population-specific pages or groups.

CoVID-19 Vaccine Efficacy in Heart Transplant Recipients, a Single Center Experience

Purpose: Transplant recipients have worse CoVID-19 survival compared to the general population, and thus are recommended to be vaccinated and boosted. Determinants of vaccination efficacy have not been well studied in heart transplant patients. Method(s): This was a prospective study of heart transplant recipients vaccinated against SARS-CoV-2 with one of the 2-dose mRNA vaccine series. Antibodies (Ab) were quantified by anti-Spike ELISA pre- and post-vaccination. Clinical data was extracted from electronic medical records. Differences in Ab detection and timing of Abs were assessed for statistical significance using Fisher's exact tests for categorical variables and t-tests for continuous variables. Result(s): Of the total 54 participants recruited from Jan 2021 to present, 6 patients were Ab positive prior to vaccination and 11 did not provide a pre-vaccination sample but were Ab positive post-vaccination. Almost half of participants (48%, n=26) received a booster 3rd dose. The mean age at vaccination was 58 +/- 11, 20% (n=11) were female, 70% (n=38) were Caucasian, and median time since transplant was 4 years (interquartile range: 2-11 years). Of the 37 Ab-negative individuals enrolled, none developed detectable Abs after a single vaccine dose and only 9 (24%) developed Abs after the 2nd vaccine dose. Interestingly in this small group, 6/9 (66%) of participants had delayed seroconversion of approximately 3 months. Unexpectedly, hyperlipidemia was positively associated with a detectable antibody response (p = 0.05) after the 2nd dose. There was also a trend toward higher age (p=0.06) and BMI (p=0.08) being associated with lack of response to the 2-dose series. Importantly, of the 28 patients who had no Ab response to the 2-dose vaccination regimen, 11/17 (65%) became Ab positive after the booster, increasing the vaccine response rate in this pre-vaccine Ab-negative group to 20/37 (54%). Looking at the total cohort of 54 participants, the overall positivity rate regardless of antigen sources (i.e., including those previously infected or for whom no pre-vaccine sample is available) is 68.5% (37/54) with a trend suggesting that absence of Ab response may be associated with prednisone treatment (p=0.06). Conclusion(s): Heart transplant recipients exhibit a low response rate to the initial 2-dose mRNA vaccines (24%), but the 3rd dose induces a response in the majority of those who failed to respond to the 2-dose series increasing overall response to over 50%. Similar to observations in the general public, non-response tended to be associated with older age and higher BMI. However, further/larger studies are needed to identify key determinants of vaccine efficacy in this population to guide management.

Effect of Covid-19 Vaccination on Markers of Rejection in Heart Transplant Recipients

Purpose: Heart transplant recipients have worse survival with COVID-19 than the general population, highlighting the importance of vaccination in these patients. The impact of vaccination on rejection in transplant recipients is not well studied. This study examines the association of vaccination for COVID-19 with changes in markers for and evidence of transplant rejection. Method(s): A retrospective analysis of heart transplant recipients vaccinated for COVID-19 was conducted at a major tertiary care center in the American Midwest. Serial antibody responses were drawn after vaccination to assess vaccine response. Data from routine transplant surveillance was extracted from the electronic medical record. Markers of rejection included Allomap, Allosure, donor specific antibodies (DSA), and endomyocardial biopsies. Only patients with comparative data within 365 days of their first COVID-19 vaccination were included for analysis. Numerical data was assessed using descriptive statistics. Categorical variables were analyzed using Fisher's exact tests. Result(s): Between January 1, 2021 and September 30, 2021, 51 heart transplant recipients had COVID-19 antibody levels checked post-vaccination. There was an increase in the mean Allomap (31.19 +/- 5.27 vs 32.14 +/- 4.30), Allosure (0.04 +/- 0.08 vs 0.11 +/- 0.12%), and biopsy C4d% (3.33 +/- 8.16 vs 10.00 +/- 12.65%) levels post-vaccination compared to those pre-vaccination. Both positive and negative responders to vaccination showed this numerical increase in markers of rejection. There was no change in biopsy grades for acute cellular rejection, nor any changes in class I DSA positivity. One patient who had a positive antibody response to the vaccine had a de novo class II DSA post vaccination. No patients in this cohort had an episode of treated rejection post vaccination. Conclusion(s): Heart transplant recipients receiving COVID-19 vaccination have numerical increases in markers of rejection like Allomap, Allosure, and biopsy C4d%. These subtle changes may suggest a difference in the immunologic environment but are of unclear significance. There was no change in biopsy proven ACR or treated episodes of rejection. Further studies are warranted to investigate the effect of COVID-19 vaccination on transplant rejection. (Table Presented).

ASSESSING THE BENEFIT, ACCEPTABILITY AND FEASIBILITY OF A STROKE-SPECIFIC PSYCHOLOGICAL SELF-MANAGEMENT INTERVENTION, HEADS:UP

Introduction: Mood disorder is a significant problem following stroke, affecting survivors (approximately 33%) up to 5 years post-stroke. Mindfulness Based Stress Reduction (MBSR) group-based courses are effective in helping people self-manage symptoms of anxiety and depression. In earlier co-creation work we developed HEADS: UP (Helping Ease Anxiety and Depression after Stroke), a 9-week stroke-specific MBSR course designed to mitigate effects of stroke which make mastery of MBSR skills challenging. Methods: In two non-randomised mixed-methods feasibility studies we further adapted HEADS: UP: face-to-face (study 1);online, in response to COVID-19 restrictions (study 2). We used community networks and social media to recruit stroke survivors (SS) with self-reported anxiety and depression. Quantitative and qualitative data were collected pre-/ post-intervention. Both studies received ethical approval. Results: We enrolled 21 community-dwelling participants. Study 1: 13 SS (female n=4, 30.8%;mean age 63.3 years). Study 2: 9 SS (female n=5, 55.6%;mean age 54.2 years). Qualitative data informed changes to research processes and HEADS: UP course materials. Participants found the course accessible and beneficial, “It's helped dramatically;I can't explain how much.” Conclusions: Stroke survivors found a stroke-specific psychological self-management intervention, HEADS: UP (face-to-face, online) acceptable, feasible and beneficial. (Table Presented).

HASHTAG RESEARCH: UTILISING SOCIAL MEDIA FOR RECRUITMENT OF STROKE SURVIVORS TO THE HEADS: UP ONLINE RANDOMISED CONTROLLED TRIAL, A STROKE-SPECIFIC PSYCHOLOGICAL SELFMANAGEMENT INTERVENTION

Background: Social media can be a useful tool in clinical trial recruitment strategy and could become increasingly important as established recruitment methods may be impaired by the COVID-19 pandemic, i.e. flyers, posters. The HEADS: UP randomized control trial utilised multiple social media platforms to access and recruit stroke survivors alongside additional, non-social media routes in response to COVID-19 pandemic restrictions. Aim: To assess the effectiveness of recruitment to the HEADS: UP clinical trial through social media. Methods: We recruited community-dwelling stroke survivors (SS) with self-reported anxiety and depression using community networks and social media. Social media recruitment allowed for direct communication with potential participants through the development of Twitter (@ HeadsUpStroke), YouTube and Reddit accounts. Facebook posts were shared on the researchers' personal accounts and UK-based stroke organization Facebook pages and groups. Results: Recruitment lasted 16 weeks and resulted in 120 leads (7.5/ week). Where recruitment source was known, social media contributed 36 leads (2.3/week). We enrolled 64 participants (female n=36, mean age 56.3 years) of which 28 were recruited through social media (43.8%;female n=15;mean age 53.0 years). Facebook was the most effective route (n=21, 75%). The least effective route was Reddit. One lead contacted the primary investigator using LinkedIn, a platform we had not included in our strategy. Costs totaled £50 (£1.79/enrolled social media participant). Conclusions: The use of social media for recruitment of stroke survivors to a psychological self-management intervention trial was both effective and low-cost, significantly contributing to overall recruitment and supplementing established research methods.

Development of a self-management workbook and virtual programme for patients in the fife pain management service during the COVID-19 pandemic

Keywords: Virtual;Pain;Covid-19 Purpose: Due to the Covid-19 crisis, face-to-face groups were cancelled in the fife pain management service (FPMS) for an indefinite period. This resulted in a group of patients, waiting to attend a face-to-face physiotherapy led education and exercise group, requiring an alternative format. Therefore, the need for a virtual alternative was established. The primary aim of the project was to develop and evaluate a patient self-learning resource that may be used on an individual basis, with virtual clinician support, or as part of a virtual group. The secondary aim was to develop and implement the use of this learning resource with patients on the physiotherapy led education and exercise group waiting list in a virtual environment. The tertiary aim of this project was to determine whether this virtual alternative would be an effective means of delivering pain management education during the covid-19 pandemic and beyond. Methods: A working group developed a patient self-management workbook based on the FPMS ‘Self-Management Jigsaw’ tool. An operational procedure was developed and implemented on how the workbook could be used during the pandemic and subsequent restrictions. Patients on the pre-pandemic group waiting list were invited to participate in the programme. The patients had a choice of (1) a telephone supported programme or (2) a video group programme. Due to the limitations of the service at the time, the telephone programme commenced first. The working group implemented the telephone programme operational procedure and collected patient and staff quantitative and qualitative feedback to determine the effectiveness of the intervention. Once feedback was analysed, the group made minor changes to the workbook and developed an operational procedure for a virtual video group programme. This programme was piloted and qualitative and quantitative data was collected, analysed and compared to the telephone pilot group. Results: This project demonstrated the usefulness of a workbook to support pain education virtually. The workbook was better received in the video group (9.75/10) to the telephone cohort (7.5/10). Due to limitations within this pilot project, we are unable to ascertain the reason for this. The telephone support was equally effective and valuable in both pilot groups from both quantitative and qualitative data. Both groups reported high satisfaction rates with an average of 9.5/10, with multiple positive qualitative feedback. This data suggest the user led video approach supported engagement within the group based on the comparison of retention rates. Conclusion(s): The project demonstrates that these programmes have the potential to be an effective means of delivering pain education and have a place within the service post Covid-19. However, they are very much in their infancy and further virtual programmes within the FPMS are required to determine longer term effectiveness and efficiency. Impact: Further research is required to determine whether the delivery of virtual physiotherapy led pain education and exercise groups are effective and offer comparable results to face-to-face groups. Additionally, research is required to establish which factors enable service users to engage effectively with virtual physiotherapy led pain education and exercise programmes. Funding acknowledgements: This work was not funded.