A Digital Inclusion Intervention to Improve Access to a Digital Health Intervention Among Digitally Excluded Adults : Mixed Methods Pilot Randomized Controlled Trial

BACKGROUND: The National Health Service 10-year health plan emphasizes an increasing shift toward digital health care delivery. However, there is limited research on how best to support, engage, and include individuals who are digitally excluded. As health care services become more digitally driven, evidence-based interventions are needed to address digital exclusion and ensure equitable access to care, particularly for people living with long-term conditions. OBJECTIVE: This study aimed to evaluate the feasibility and acceptability of providing digital literacy training alongside a digital health intervention (DHI; Ex-Tab intervention), compared with providing a DHI alone. Kidney Beam, a DHI designed to promote physical activity and improve quality of life in people with chronic kidney disease (CKD), was used as an exemplar DHI. METHODS: This mixed methods, single-site pilot randomized controlled trial recruited 40 adults with CKD who were digitally excluded. Digital exclusion was defined as lacking access to a Wi-Fi-enabled digital device or having a Digital Health Care Literacy Scale (DHLS) score of <7 (range 0-21). Participants were randomized 1:1 to receive either the Kidney Beam Ex-Tab intervention or Kidney Beam alone (control). The intervention group received a Wi-Fi-enabled iPad on loan with Kidney Beam preinstalled, digital literacy training, and ongoing support to access the 12-week Kidney Beam program (twice weekly live exercise and education sessions). The control group received sign-up instructions for Kidney Beam only. Feasibility outcomes were assessed against a priori progression criteria and included screening, recruitment, retention, adherence, safety, and acceptability. Secondary outcomes included the Kidney Disease Quality of Life Questionnaire, Chalder Fatigue Questionnaire, and Patient Health Questionnaire-4. Outcomes were measured at baseline and 12 weeks. Acceptability and user experience were explored through semistructured interviews with participants from both groups at 12 weeks (n=25). RESULTS: Between September 2023 and September 2024, a total of 169 individuals were screened and 40 were enrolled (median age 66.5 years; 20 male individuals; median DHLS score: 4). Twenty-one participants were randomized to the Kidney Beam Ex-Tab group and 19 to the Kidney Beam alone group. Of the 40 participants, 35 (88%) completed the 12-week follow-up (intervention: n=18; control: n=17). All prespecified feasibility criteria for recruitment, retention, adherence, and safety were met. Qualitative findings indicated that the tablet loan and digital literacy training were acceptable and highly valued, enhancing confidence, motivation, and DHI engagement. Providing loaned devices was particularly important for overcoming access barriers, especially for participants unable to afford their own device. CONCLUSIONS: Providing Wi-Fi-enabled devices and digital literacy training alongside a DHI was feasible and acceptable for people with lower digital literacy levels. The findings support progression to a future definitive multicenter trial or implementation study and offer transferable insights for the design of digital inclusion strategies for other long-term health conditions.