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NCT Number: NCT06796309

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario del Sureste

Madrid, 28500, Spain

Location status: Recruiting

Location contact

ANA VADILLO CORTÁZAR

CONTACT

[email protected]

+34 918394527

ANA VADILLO CORTÁZAR

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trak Telerehabilitation Platform

Other

The exercise protocol designed is carried out through TRAK, the digital rehabilitation tool.

conventional rehabilitation program

Other

Exercise protocol with the methodology of conventional clinical practice.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Number of patients using the platform

    Time frame: week 8

    The total number of patients who are using the TRAK platform.

Study contacts

Contact information is provided by the study sponsor or research team.

JUAN F DUARTE MENDOZA

CONTACT

[email protected]

+34 677 33 4869

Sponsors and collaborators

Lead sponsor

Trak Health Solutions S.L.

Industry

Collaborators

  • University Hospital Gregorio Marañón

Registry information

Official study title

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

Acronym: TRAK-RURAL

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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