Assessment of Rural Health Care: Implementing TRAK Digital Tool for Quality and Accessible Services (TRAK-RURAL)

Trak Health Solutions S.L.

Status: Enrolling

Conditions: Shoulder Pain

Treatments: Other: Trak Telerehabilitation Platform; Other: Conventional Rehabilitation Program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06796309

TRAK-RURAL

Details and patient eligibility

About

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).

Full 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.

Enrollment: 95 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria population 1:

• They carry out their activity in a rural environment.
• That they know how to use the tool.
• That they have a device with which to use the tool.
• That they have an e-mail address.
• That they have an Internet connection.
• That they have signed the informed consent form.

Exclusion Criteria population 1:

• N/A

Inclusion Criteria population 2:

• Seniors.
• Patients with omalgia of more than 6 months of evolution.
• Who have a device with which to use the tool.
• Who have a device with which to use the tool.
• Who have an Internet connection.
• Who have an e-mail address.
• Who have signed the informed consent form.

Exclusion Criteria population 2:

• Patients with cognitive impairment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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95 participants in 3 patient groups

TRAK treatment group (Population 2)

Experimental group

Description:

Patients will use Trak platform for 8 weeks (2 months) for their exercise program. The use of the tool involves performing the corresponding therapeutic exercise program through it. The frequency of the exercises will be determined by the healthcare professional responsible for the patient, based on the needs identified during the assessment, ranging from 3 to 7 days per week.

Treatment:

Other: Trak Telerehabilitation Platform

Control Group (Population 2)

Active Comparator group

Description:

Patients in the control group will undergo the same rehabilitation period (8 weeks) but following standard clinical practice.

Treatment:

Other: Conventional Rehabilitation Program

Healthcare professional Group (Population 1)

Other group

Description:

Healthcare professionals who will have access to the tool to prescribe exercise sessions for their patients, monitor their progress, adapt and modify the exercise program, communicate with patients to address their questions, and track their progress over time.

Treatment:

Other: Trak Telerehabilitation Platform