ABSTRACT
BACKGROUND AND AIMS: Adverse weight gain within the first year of receiving a kidney transplant is associated with adverse health outcomes. Kidney transplant recipients (KTRs) have asked for support with physical activity and following healthy lifestyles. There is no recognised intervention to address weight gain prevention for new KTRs. Usability of an online intervention to prevent weight gain in new KTRs has recently been reported. The aim of this study was to examine the feasibility of undertaking a randomised controlled trial of an online intervention group (IG) compared with usual care UC) to address weight gain prevention in new KTRs. METHOD: Participants were recruited from two south-London transplant sites, had a kidney transplant within 3 months, and had access to an internet compatible device. Exclusion criteria included history of an unstable medical condition, non- English speaking or <18 years. At baseline assessment participants were randomized to either UC or IG. The UC group received standard dietary and physical activity education. The IG received access to a 12-week password-protected website, weekly email reminders, and could contact the research physiotherapist via a secure message function. Primary feasibility outcomes included screening rates, consent rates, adherence to study visits, acceptability of outcomes, engagement with the intervention, retention, willingness to be randomized, adverse events, hospitalizations, experience using the online intervention and experience taking part in the trial. Secondary outcomes were recorded at baseline, 3- and 12-months. These included body weight, body mass index (BMI), bioimpedance (BIA), pulse wave velocity (PWV), augmentation index (AI) and six-minute walk distance (6MWD). RESULTS: Seventeen new KTRs (median age 49 years, 10 males, median 62 days post-transplant) were randomized to the IG (n = 9) or UC (n = 8). Screening rate was 84.2% (95% CI: 68.8-94.0), recruitment 62.5% (95% CI: 43.7-79.0) and intervention adherence at 12 months was 76.4% (95% CI: 50.0-93.2). All pre-set progression criteria for feasibility were achieved. There were no associated adverse events. Qualitative analysis revealed four themes;optimizing participation and recruitment, impact of Coronavirus disease 2019 (COVID-19), engagement is a choice (technical and personal factors) and mechanisms of action (assessment and intervention factors). The IG appeared to stabilize median body weight across the study;94.5 kg, (IQR: 63.0, 102.0), 95.0 kg, (IQR: 66.7, 105.3) and 94.7 kg (IQR: 77.2, 117.3). Whereas UC participants increased [81.3 kg, (IQR: 73.6,94.6), 86.2 kg (75.4, 96.5) and 93.3 kg (70.3, 101.9)]. IG increased 6MWD [450 m, (IQR: 450, 540), 525 m (IQR: 472.5, 615) and 495 m (IQR: 465, 615)] and UC decreased 6MWD [517.5 m (IQR: 436, 570), 507.5 m (IQR: 442.5, 605) and 435 m (IQR 435, 555)]. All other outcomes were comparable across the sample. CONCLUSION: Limitations include inadequate power and small sample size, and it was a single-centre study. Integrated mixed methods analysis demonstrate congruency of both qualitative and quantitative data. Participant attitudes, experiences and engagement with the study and intervention provide insight for future trial design. A future definitive trial is warranted and welcomed by KTRs.
ABSTRACT
Keywords: Chronic Kidney Disease;Wellbeing;Telerehabilitation Purpose: To establish and evaluate a novel digital intervention to provide people living with chronic kidney disease (CKD) across the UK a means to manage their physical health and emotional wellbeing through the Coronavirus-19 (COVID-19) pandemic and beyond. There is a significant association between CKD and more severe COVID-19 infection and a greater mortality rate than the general population. People living with end-stage CKD were classified as ‘extremely clinically vulnerable’ and asked to shield at home. Since people living with CKD do not receive routine physical and emotional wellbeing support as part of routine NHS care, a home-based solution was developed to fill this urgent need. Methods: We partnered with online exercise platform Beam to co-design Kidney Beam (https://beamfeelgood.com/home), a kidney-specific digital health platform, which aimed to offer people living with CKD a way to improve physical and mental health through live and on demand movement classes and educational videos from multidisciplinary experts, all from their own home. The platform was free at point of access for all adults with CKD. A voluntary survey collecting demographic data was completed by participants on sign-up and upon completion of the 6-month pilot to establish whether participants were meeting current physical activity guidelines, to investigate perceptions of health, and collect usability feedback about the platform. Results: A total of 959 participants aged > 18 years from across the UK signed up to the platform within the 6-month time period. Of these, 71% were female, 50% were pre-dialysis and 32% had received a kidney transplant. A total of 1,105 on-demand classes and 829 live classes were completed. The pre-pilot survey was completed by 276 participants (29%), with 76 completing the post-pilot survey. The sample was representative of the baseline sign-ups. Responders to the survey had an 8% improvement in general health (change from perception of poor or fair health to good or very good health) by the end of the pilot. Additionally, 6% of responders reported an improvement in the perception of their emotional health. The pre-pilot survey revealed that only 31% of responders were achieving the recommended physical activity levels of > 150 minutes weekly moderate intensity activity, which had increased to 50% of post-pilot responders. Strength training on 2 days of the week was reported by 31% of responders pre-pilot, compared with 42% post-pilot. 96% of participants would recommend Kidney Beam to a friend, with the biggest reported benefits being that it was kidney-specific and delivered by specialist kidney healthcare professionals. Conclusion(s): The Kidney Beam pilot was a pragmatic programme of care, rapidly evolved to deliver vital physical activity and emotional wellbeing support to people living with CKD at a time of crisis. This platform has been funded for a further 12 months, whilst a randomised controlled trial to evaluate clinical efficacy and cost effectiveness is undertaken to help inform NHS commissioning of the programme. Impact: This has been granted funding for an RCT to evaluate clinical efficacy and cost effectiveness. If successful this will lead to the potential for NHS commissioning, as part of routine care. Funding acknowledgements: The pilot study was a collaboration between King's College Hospital, Kidney Research UK (KRUK) and Beam, a health-technology platform supporting people with health conditions to stay physically active. This work was not funded by the CSP Charitable Trust.