The Feasibility and User-Experience of a Digital Health Intervention Designed to Prevent Weight Gain in New Kidney Transplant Recipients-The ExeRTiOn2 Trial
Half of kidney transplant recipients (KTRs) gain more than 5% of their body weight in the first year following transplantation. KTRs have requested support with physical activity (PA) and weight gain prevention, but there is no routine care offered. There are few high-quality studies investigating the clinical value of diet, PA or combined interventions to prevent weight gain. The development and evaluation of theoretically informed complex-interventions to mitigate weight gain are warranted. The aims of this mixed-methods randomized controlled trial (RCT) were to explore the feasibility, acceptability and user-experience of a digital healthcare intervention (DHI) designed to prevent post-transplant weight gain, in preparation for a large multi-center trial. New KTRs (<3 months) with access to an internet compatible device were recruited from a London transplant center. The usual care (UC) group received standard dietary and PA advice. The intervention group (IG) received access to a 12-week DHI designed to prevent post-transplant weight gain. Primary feasibility outcomes included screening, recruitment, retention, adherence, safety and hospitalizations and engagement and experience with the DHI. Secondary outcomes (anthropometrics, bioimpedance, arterial stiffness, 6-minute walk distance and questionnaires) were measured at baseline, 3- and 12-months. 38 KTRs were screened, of which 32 (84.2%) were eligible, and of those 20 (62.5%) consented, with 17 participants (85%) completing baseline assessment (Median 49 years, 58.8% male, Median 62 days post-transplant). Participants were randomized using a computer-generated list (n = 9 IG, n = 8 UC). Retention at 12-months was 13 (76.4%) (n = 6 IG, n = 7 UC). All a priori progression criteria were achieved. There were no associated adverse events. Reflexive thematic analysis revealed four themes regarding trial participation and experience whilst using the DHI. Halting recruitment due to COVID-19 resulted in the recruitment of 40% of the target sample size. Mixed-methods data provided important insights for future trial design. A definitive RCT is warranted and welcomed by KTRs.
CLINICAL TRIAL REGISTRATION:www.clinicalTrials.gov, identifier: NCT03996551.
CET Conclusion
| Reviewer: | Dr Liset Pengel, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford |
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| Conclusion: | The small, mixed-methods, randomised controlled trial explored the feasibility, acceptability and user experience of a 12-week digital intervention aimed at preventing weight gain in kidney transplant recipients. Seventeen participants were randomised to the intervention and usual care groups according to a computer-generated list. A formal power calculation was not conducted due to the explorative nature of the study but a target sample of 50 participants was set. Due to COVID-19, recruitment was stopped early and follow-up of patients was limited resulting in missing data. Seventeen patients were randomised and four patients dropped out of the study over the 12-month study period. The adherence rate to the study intervention was 67%. There were no serious adverse events. Thirteen participants from both groups completed individual interviews that explored their experiences regarding the intervention and participation in the trial. The analysis identified four themes regarding the study intervention experience, i.e. ‘optimizing participant recruitment’, ‘the impact of COVID-19’, ‘engagement with the ExeRTiOn DHI (study intervention) is a choice’ and ‘mechanisms of action associated with a positive study experience’. Integration of qualitative and quantitative results suggests that an RCT using the ExeRTiOn DHI is feasible and acceptable to new kidney transplant recipients. |
Methodological quality
| Jadad score | 3 |
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| Allocation concealment | YES |
| Data analysis | MODIFIED INTENTION TO TREAT |
Study Details
| Aims: | This study aimed to investigate the feasibility, acceptability and experience of a digital healthcare intervention (DHI) which was designed to prevent weight gain following kidney transplantation, and provide important insights for a future multi-centre trial design. |
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| Interventions: | Participants were randomised to either the DHI intervention group or the usual care group. |
| Participants: | 17 kidney transplant recipients. |
| Outcomes: | Primary feasibility endpoints were screening, recruitment, adherence, retention, safety and hospitalisations, as well as experience and engagement with the DHI. Secondary endpoints included anthropometrics, arterial stiffness, bioimpedance, 6-minute walk distance and questionnaires completed at each study visit. |
| Follow Up: | 12 months |
Metadata
| Funding: | Non-industry funding |
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| Publication type: | Case Reports, Randomised Controlled Trial |
| Trial registration: | ClinicalTrials.gov - NCT03996551 |
| Organ: | Kidney |
| Language: | English |
| Author email: | ellen.castle@nhs.net |
| MeSH terms: | Kidney Transplantation |