Effects of the ActiveHip+ mHealth intervention on the recovery of older adults with hip fracture and their family caregivers: a multicentre open-label randomised controlled trial.

Background: Mobile health (mHealth) systems are a promising alternative for rehabilitation of hip fracture, addressing constrained healthcare resources. Half of older adults fails to recover their pre-fracture routines, which imposes a burden on caregivers. We aimed to test the effectiveness of the 3-month ActiveHip + mHealth intervention on physical and psychological outcomes of older adults with hip fracture and their family caregivers. Methods: In a multicentre open-label randomised controlled trial conducted across 3 hospitals in Andalusia (Spain), patients older than 65 with a hip fracture, who were previously independent and lacked cognitive impairment were recruited alongside with their caregivers. Participants were randomly allocated (1:1) to the intervention group (ActiveHip+) or control (usual care) group. The intervention group underwent a 12-week health education and tele-rehabilitation programme through the ActiveHip + mHealth intervention. The primary outcome, physical performance, was assessed using the Short Physical Performance Battery at three time points: at hospital discharge (baseline), 3-month after surgery (post intervention) and 1-year after surgery follow-up. Primary analyses of primary outcomes and safety data followed an intention-to-treat approach. This study is registered at ClinicalTrials.gov, NCT04859309. Findings: Between June 1st, 2021 and June 30th, 2022 data from 105 patients and their caregivers were analysed. Patients engaged in the ActiveHip + mHealth intervention (mean 7.11 points, SE 0.33) showed higher physical performance compared with patients allocated in the control group (mean 5.71 points, SE 0.32) at 3 months after surgery (mean difference in change from baseline 1.40 points, SE 0.36; puncorrected = 0.00011). These benefits were not maintained at 1-year after surgery follow-up (mean difference in change from baseline 0.19 points, SE 0.47; puncorrected = 0.68). No adverse events, including falls and refractures, were reported during the tele-rehabilitation sessions. At 3-months, the intervention group had 2 falls, compared to 4 in the control group, with no observed refractures. At the 1-year follow-up, the intervention group experienced 7 falls and 1 refracture, while the control group had 13 falls and 2 refractures. Interpretation: This study suggests that the ActiveHip + mHealth intervention may be effective for recovering physical performance in older adults with hip fracture. Importantly, the implementation of ActiveHip + into daily clinical practice may be feasible and has already been adopted in 18 hospitals, mostly in Spain but also in Belgium and Portugal. Thus, ActiveHip + could offer a promising solution when rehabilitation resources are limited. However, its dependence on caregiver support and the exclusion of participants with cognitive impairment makes it necessary to be cautious about its applicability. In addition, the non-maintenance of the effectiveness at 1-year follow-up highlights the need of refinement the ActiveHip + intervention to promote long-lasting behavioural changes. Funding: EIT Health and the Ramón y Cajal 2021 Excellence Research Grant action from the Spanish Ministry of Science and Innovation.