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

NCT ID: NCT06796309

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-07

Study Completion Date

2025-05-01

Brief Summary

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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

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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

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective experimental study with 95 participants (15 from Population 1; 80 from Population 2) included based on compliance with inclusion and exclusion criteria.

Population 1:

Fifteen healthcare professionals will be recruited.

The intervention targets patients with musculoskeletal pathologies using randomized allocation into two groups: a treatment group utilizing Trak and a control group following conventional rehabilitation methods.

Population 2:

Eighty patients will be randomly assigned to the experimental or control group in a 1:1 ratio.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Randomization is achieved through permuted block randomization with a 1:1 allocation ratio, ensuring balance. The intervention includes remote rehabilitation exercises supported by healthcare professionals, with outcomes assessed independently for both populations (healthcare staff and patients).

Study Groups

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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.

Group Type EXPERIMENTAL

Trak Telerehabilitation Platform

Intervention Type OTHER

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

Control Group (Population 2)

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

Group Type ACTIVE_COMPARATOR

Conventional Rehabilitation Program

Intervention Type OTHER

Exercise protocol with the methodology of conventional clinical practice.

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.

Group Type OTHER

Trak Telerehabilitation Platform

Intervention Type OTHER

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

Interventions

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Trak Telerehabilitation Platform

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

Intervention Type OTHER

Conventional Rehabilitation Program

Exercise protocol with the methodology of conventional clinical practice.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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

* N/A


* Patients with cognitive impairment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Gregorio Marañón

OTHER

Sponsor Role collaborator

Trak Health Solutions S.L.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ANA VADILLO CORTÁZAR

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario del Sureste

Locations

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Hospital Universitario del Sureste

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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JUAN F DUARTE MENDOZA

Role: CONTACT

+34 677 33 4869

Facility Contacts

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ANA VADILLO CORTÁZAR

Role: primary

+34 918394527

Other Identifiers

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TRAK-RURAL

Identifier Type: -

Identifier Source: org_study_id

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