Study Design and Participants
ADVERSE EVENTS, RECRUITMENT
This single-blinded, randomized control pilot study was conducted between 22 April 2020–2 August 2021. The study was approved by the Institutional Review Board of Pusan University Yangsan Hospital (IRB no. 02-2019-018) and registered on Clinictrials.gov (NCT05275153). All participants provided written informed consent prior to initial evaluations.Participants were community-dwelling adults aged Individuals were recruited through recruitment notices at university hospitals and community centers for senior citizens in Yangsan-si city, Gyeongsangnam-do province. The required sample size was estimated using Participants were allocated to either the HB-CCT or control groups by a computer-generated random number list, with 25 participants randomly designated to each group. The HB-CCT intervention in the HB-CCT group was performed three times a week over an 8-week period for a total of 24 occurrences The data were transmitted immediately, and the administrator monitored the participants daily. Administrators phoned the participants each week to ensure that the interventions were without issues and to document adverse events or concomitant drug changes. The control group did not receive an intervention, and the administrator called weekly for eight weeks in order to monitor for any cognitive, environmental, or psychological changes. Treatments and medications were not restricted, and the regimen and dose that had been prescribed from the first screening visit date were maintained. The pre- and post-evaluations and distribution and collection of tablet PCs were conducted with participants visiting the hospital directly, whereas the intervention was conducted in the participants’ homes. See Flowchart of the study progress.