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

April 7, 2025 updated by: Trak Health Solutions S.L.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28500
        • Recruiting
        • Hospital Universitario del Sureste
        • Contact:
        • Principal Investigator:
          • ANA VADILLO CORTÁZAR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRAK treatment group (Population 2)
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.
Other: Trak Telerehabilitation Platform
The exercise protocol designed is carried out through TRAK, the digital rehabilitation tool.
Active Comparator: Control Group (Population 2)
Patients in the control group will undergo the same rehabilitation period (8 weeks) but following standard clinical practice.
Other: Conventional Rehabilitation Program
Exercise protocol with the methodology of conventional clinical practice.
Other: Healthcare professional Group (Population 1)
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.
Other: Trak Telerehabilitation Platform
The exercise protocol designed is carried out through TRAK, the digital rehabilitation tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Telemedicine Usability Questionnaire (TUQ).
Time Frame: Last visit, week 8
The TUQ is a questionnaire specifically designed to measure (from 17 to 109 points) the usability of telemedicine systems from the perspective of healthcare personnel.
Last visit, week 8
Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ).
Time Frame: Last visit, week 8
Scale designed to evaluate the satisfaction and usefulness perceived by telemedicine users from 17 to 85 points.
Last visit, week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
European quality of life 5 dimension questionnaire (EuroQol-5D)
Time Frame: week 1 and 8
Generic and standardized questionnaire developed to describe and assess health-related quality of life. This questionnaire has an EVA scale from 0 to 100 and 5 questions that gives a 5 digit patient profile (From 11111 if the patients does not have problems on any item to 33333 if the patients have severe problems). The items valued are personal care, daily activities, mobility, pain and anxiety/depression.
week 1 and 8
Focus on Shoulder Pain and Disability Index (SPADI-Br).
Time Frame: week 1 and 8
The SPADI-Br was designed to evaluate the degree of shoulder pain and discomfort in performing activities of daily living from 0 to 130 points.
week 1 and 8
Number of patients using the platform
Time Frame: week 8
The total number of patients who are using the TRAK platform.
week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trak Health Solutions S.L.

Collaborators

University Hospital Gregorio Marañón

Investigators

  • Principal Investigator: ANA VADILLO CORTÁZAR, Hospital Universitario del Sureste

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

January 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRAK-RURAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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