mHealth to Improve the Experience, Adherence to Drug Treatment and Positive Mental Health

Fracture of Femur Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669040
• Other study ID #: Intervention EFE
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: April 2023

Study information

• Verified date: December 2022
• Source: Hospital Clinic of Barcelona
• Contact: Gemma Marcos Anton
• Phone: +34657915371
• Email: gmarcos[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 278
• Est. completion date: April 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• presence of psychological pathologies or cognitive impairment

• isolation in hospital admission

Related Conditions & MeSH terms

• Femoral Fractures
• Fracture of Femur

Intervention

Other:
• Pharmacological education
Inform the patient of the medication that is being taken and how it has to be taken; What is it for and the side effects and/or adverse reactions.
• Training in the use of MyPlan Aplication
Review of the use of the aplication
• Patient Experience
How do you feel? Sad feelings and frustration. Achievements day by day, think positive. Importance of interpersonal relationships. Explain activities to relax the mind

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Amgen, University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient experience questionnaire-15. Changes in outcomes are assessed at three time points.	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.	at 1rst day (before intervention), at 7th day (at discharge after intervention), and 25th day (after discharge)
Primary	Morinski-Green Questionnaire. Changes in outcomes are assessed at three time points.	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.	at 1rst day, at 7th day and 25th day.
Primary	Positive Mental Health Questionnaire. Changes in outcomes are assessed at three time points.	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%.	at 1rst day, at 7th day and 25th day.