2.2. Study Design

The PREMIO study was a two-arm, pragmatic, randomized controlled trial. All GPs identified through their membership in the national medical organization FIMMG were invited to participate in the study through presentations, e-mails, letters and face-to-face interviews. A total of 117 GPs agreed to participate, and each doctor committed to enrolling 20 patients who were considered at risk of falling, according to the then-current Italian guidelines for the prevention of falls at home among the elderly [27].

Patients were randomized using a sealed-envelope system. Participating GPs received randomly generated treatment allocations in sealed opaque envelopes. The envelope was opened once a patient who met the inclusion criteria agreed to participate in the program.

All patients randomized to the intervention group received a booklet with physical-activity recommendations (Table S2).

They also received a Fall Diary (Table S3) and a Physical Activity Diary (Table S4), both to be completed daily and sent to the GP every three months. To complete the intervention, the patients received a set of dietary recommendations (Table S5).

The patients in the control arm received the same set of dietary recommendations (as required by the ethics committee) and the Fall Diary.

For each enrolled patient, the GP completed a patient data sheet with demographic and medical data based on the patient’s clinical records. These data and the information from the fall and physical-activity diaries were centralized through a web platform for the creation and management of the PREMIO database at NETMEDICA (www.netmedicaitalia.it, accessed on 20 October 2023).

Within 2 weeks of enrollment, the GP was to visit each patient’s home, identify home risks and provide recommendations to address them, and complete the environmental risk survey module (Table S6). All GPs contacted the patients monthly to monitor compliance and reinforce motivation to participate in the study.

The intervention lasted 12 months. At the end of the study, all participating patients were asked to complete a customer-satisfaction questionnaire based on a 7-item Likert scale (Table S7) to assess the acceptability of the program.