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

NCT06796309 | Recruiting DMC

• 1 other identifier: TRAK-RURAL
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Shoulder Pain

Keywords

shoulder pain; telerehabilitation; telemedicine; exercise program; physiotherapy; healthcare personnel

Outcome Measures

Primary Outcomes (2)

• Telemedicine Usability Questionnaire (TUQ).

  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).

  Scale designed to evaluate the satisfaction and usefulness perceived by telemedicine users from 17 to 85 points.

  Last visit, week 8

Secondary Outcomes (3)

• European quality of life 5 dimension questionnaire (EuroQol-5D)

  week 1 and 8

• Focus on Shoulder Pain and Disability Index (SPADI-Br).

  week 1 and 8

• Number of patients using the platform

  week 8

Study Arms (3)

TRAK treatment group (Population 2)

EXPERIMENTAL

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

Control Group (Population 2)

ACTIVE COMPARATOR

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

Other: Conventional Rehabilitation Program

Healthcare professional Group (Population 1)

OTHER

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

Interventions

Trak Telerehabilitation Platform OTHER

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

Healthcare professional Group (Population 1); TRAK treatment group (Population 2)

Conventional Rehabilitation Program OTHER

Exercise protocol with the methodology of conventional clinical practice.

Control Group (Population 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• N/A
• 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.
• Patients with cognitive impairment.

Sponsors & Collaborators

• Trak Health Solutions S.L.: lead
• University Hospital Gregorio Marañón: collaborator

Study Sites (1)

Hospital Universitario del Sureste

Madrid, 28500, Spain

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ANA VADILLO CORTÁZAR

  Hospital Universitario del Sureste

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JUAN F DUARTE MENDOZA

CONTACT

+34 677 33 4869; juanfernando@trak.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 28, 2025
• Study Start: February 7, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

ES (1)