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临床试验/NCT06796309
NCT06796309招募中不适用

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

Trak Health Solutions S.L.2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2024年2月7日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
95
试验地点
2
主要终点
Telemedicine Usability Questionnaire (TUQ).

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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).

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Telemedicine Usability Questionnaire (TUQ).

时间窗: 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).

时间窗: Last visit, week 8

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

次要结局

  • 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)

研究者

发起方
Trak Health Solutions S.L.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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