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Clinical Trials/NCT06796309
NCT06796309RecruitingNot Applicable

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

Trak Health Solutions S.L.1 site in 1 country95 target enrollmentStarted: February 7, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
95
Locations
1
Primary Endpoint
Telemedicine Usability Questionnaire (TUQ).

Study Overview

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).

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

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).

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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:
  • •Inclusion Criteria population 2:
  • •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.

Arms & Interventions

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.

Intervention: Trak Telerehabilitation Platform (Other)

Control Group (Population 2)

Active Comparator

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

Intervention: Conventional Rehabilitation Program (Other)

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.

Intervention: Trak Telerehabilitation Platform (Other)

Outcomes

Primary Outcomes

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.

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

  • 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)

Investigators

Sponsor
Trak Health Solutions S.L.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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