Clinical trial NCT06796309: Assessment of Rural Health Care: Implementing TRAK Digital Tool for Quality and Accessible Services
Official title: Assessment of Rural Health Care: Introduction of the TRAK Digital Tool for Quality and Accessible Medical Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Pain
Keywords: shoulder pain
telerehabilitation
telemedicine
exercise program
physiotherapy
healthcare personnel
Lead sponsor: Trak Health Solutions S.L.
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Gregorio Marañón
First posted: 2025-01-28
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Telemedicine Usability Questionnaire (TUQ).
timeFrame: Last visit, week 8
measure: Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ).
timeFrame: Last visit, week 8
Secondary outcomes:
measure: European quality of life 5 dimension questionnaire (EuroQol-5D)
timeFrame: week 1 and 8
measure: Focus on Shoulder Pain and Disability Index (SPADI-Br).
timeFrame: week 1 and 8
measure: Number of patients using the platform
timeFrame: week 8
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario del Sureste
Study officials:
affiliation: Hospital Universitario del Sureste
name: ANA VADILLO CORTÁZAR
role: PRINCIPAL_INVESTIGATOR
References: