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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fracture of Femur
• Intervention / Treatment: Other: Pharmacological education; Other: Training in the use of MyPlan Aplication; Other: Patient Experience

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 278
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gemma Marcos Anton; Phone Number: +34657915371; Email: gmarcos@clinic.cat
• Study Contact Backup: Name: Montserrat Puig LLobet; Phone Number: +34934035510; Email: monpuigllob@ub.edu

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic De Barcelona
    • Contact: Gemma Marcos; Phone Number: +34657915371; Email: gmarcos@clinic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patient experience	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.; Other: Training in the use of MyPlan Aplication; Review of the use of the aplication; Other: 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
Active Comparator: Adherence to drug treatment	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.; Other: Training in the use of MyPlan Aplication; Review of the use of the aplication
Active Comparator: Positive mental health	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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.
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.

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Amgen; University of Barcelona
• Investigators: Study Director: Carmen Moreno Arroyo, UB

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 29, 2022
• First Posted (Actual): December 30, 2022

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: mobile health; mental health; mHealth; education; nurse; patient experience; protocol; adherence medication
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures
• Other Study ID Numbers: Intervention EFE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Publication of an article with preliminary results in the BioMed Central Public Health magazine.; Presentation of results at National Congress of Mental Health Nursing. Spain.; Publication of results article in "Revista Española de Enfermería de Salud Mental" magazine.; Presentation of results at Investen, Annual Meeting on Care Research. Spain.
• IPD Sharing Time Frame: February 2024
• IPD Sharing Access Criteria: Healthcare professionals
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No