跳至主要内容
临床试验/NCT05669040
NCT05669040招募中不适用

mHealth to Improve the Experience, Adherence to Drug Treatment and Positive Mental Health of Patients Diagnosed With Femur Fracture: Protocol for a Quasi-experimental Study

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2022年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
278
试验地点
2
主要终点
Patient experience questionnaire-15. Changes in outcomes are assessed at three time points.

研究概览

简要总结

The present study aims to evaluate the effectiveness of a pharmacological nursing educational intervention (EFE) with "Myplan Aplication" about the patient's experience, adherence to pharmacological treatment, and positive mental health of patients with femur fracture.

详细描述

Once the informed consent has been obtained, the investigators will explain to the patient the pharmacological treatment with the support of an aplication (what it is for, how the medication should be taken, possible adverse effects), also the investigators will share time with the patient during the 4 face-to-face training sessions. The investigators will accompany during their hospital stay, offering to pacients telematic support upon discharge with the treatment and until the end of the study. This is a quasi-experimental non-randomized study with 3 phases of data collection. Possible adverse reactions, if any, will be recorded.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Single (Investigator)

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

  • diagnosis of femur fracture
  • knowledge of the Spanish language
  • 24-hour admission to the traumatology unit
  • level of consciousness on the Glasgow scale of 15
  • have access to a mobile device
  • ability to participate in the pilot study
  • be able to provide written informed consent or obtain consent from a legal representative.

排除标准

  • presence of psychological pathologies or cognitive impairment
  • isolation in hospital admission

结局指标

主要结局

Patient experience questionnaire-15. Changes in outcomes are assessed at three time points.

时间窗: at 1rst day (before intervention), at 7th day (at discharge after intervention), and 25th day (after discharge)

This questionnaire allows us to explore the perception of patients about the information process and participation in decision-making during hospital admission. The responses range is from always or almost always/quite frequently/sometimes/never or almost never.This questionnaire allows us to explore the perception of patients about the information process and participation in decision-making during hospital admission. The responses range from always or almost always/quite frequently/sometimes/never or almost never.

Positive Mental Health Questionnaire. Changes in outcomes are assessed at three time points.

时间窗: at 1rst day, at 7th day and 25th day.

This scale evaluates mental health from a positive perspective. It consists of 39 items distributed in six factors: personal satisfaction, pro-social attitude, self-control, autonomy, problem solving and self-acting, and interpersonal relationship skills. Its measurement is carried out by means of a Likert-type response that goes from always or almost always, quite frequently, sometimes, never or almost never. Validated in the general population in favorable psychometric values: global reliability of 0.88 and an applied variance of 45%.

Morinski-Green Questionnaire. Changes in outcomes are assessed at three time points.

时间窗: at 1rst day, at 7th day and 25th day.

This questionnaire allows assessing adherence to the prescribed treatment. It consists of a series of 4 dichotomous yes/no questions that reflects the degree of behavior of the patient's compliance, information on the causes of non-compliance.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gemma Marcos

Principal Investigator

Hospital Clinic of Barcelona

研究点 (2)

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