NCT06796309

Assessment of Rural Health Care: Implementing TRAK Digital Tool for Quality and Accessible Services

Assessment of Rural Health Care: Introduction of the TRAK Digital Tool for Quality and Accessible Medical Care

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: Trak Health Solutions S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to analyze the usability and degree of satisfaction of two populations, healthcare personnel (Population 1) in rural areas and their patients (Population 2), with the TRAK tele-rehabilitation tool. Participants will undergo telerehabilitation treatment through the TRAK platform for eight weeks (treatment group) or follow an at home exercise protocol (control group).

Detailed description

The recruitment process for this study is aimed at patients with shoulder pain (population 2) and healthcare personnel (population 1). After the initial screening, individuals who meet the study's predefined inclusion criteria will be invited to participate. Before enrollment, written informed consent will be obtained from all participants, ensuring ethical compliance and respect for individual autonomy. The healthcare personnel (population 1) will use Trak during the entire study period, from the time of entry into the study to the time of exit. The study cohort will consist of patients randomly assigned to the experimental group (EG) and the control group (CG) on the first in person visit for the population 2 (patients). Regardless of group assignment, all patients will undergo baseline health assessments, ensuring that their individual needs are met. The satisfaction questionnaire will be deferred until post-intervention for both groups. Participants in both groups will begin by filling out the Quality of Life Scale (EuroQol 5). and Shoulder Functional Assessment Scale (SPADI-Br) on the first visit. In the case of the treatment group (EG), the participants will use the platform following the treatment prescribed by their health professionals for a period of 2 months. in the case of the control group (CG), the patients will follow the usual clinical practice treatment (they will receive the exercise protocol in paper format). At the end of the treatment period, a final face-to-face visit will be made. Patients (population 2) will undergo 8 weeks of treatment through the TRAK tool (https://www.trakphysio.com/es/) in the EG. Patients from the EG will carry out the treatment through the platform at home, and those from the CG will follow an on paper exercise protocol based on the usual (in-person) clinical practice methodology. Both groups will perform exercises in these rehabilitation sessions to improve shoulder mobility. The results will be evaluated using different métrics, such as Telemedicine Usability Questionnaire (TUQ) and Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ), wich are the main ones, number of patients using the platform, the EuroQol-5D and the shoulder functional evaluation scale (SPADI-Br). These scales will be completed on paper at the beginning and end of the study for both groups.

Conditions

• Shoulder Pain

Interventions

Type	Name	Description
OTHER	Trak Telerehabilitation Platform	The exercise protocol designed is carried out through TRAK, the digital rehabilitation tool.
OTHER	Conventional Rehabilitation Program	Exercise protocol with the methodology of conventional clinical practice.

Timeline

• Start date: 2024-02-07
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2025-01-28
• Last updated: 2025-04-08

Locations

1 site across 1 country: Spain