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

NCT05669040 | Unknown DMC

• 1 other identifier: Intervention EFE
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fracture of Femur

Keywords

education; patient experience; adherence medication; mental health; mobile health; nurse; mHealth; protocol

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (3)

Patient experience

ACTIVE COMPARATOR

Other: Pharmacological education; Other: Training in the use of MyPlan Aplication; Other: Patient Experience

Adherence to drug treatment

ACTIVE COMPARATOR

Other: Pharmacological education; Other: Training in the use of MyPlan Aplication

Positive mental health

ACTIVE COMPARATOR

Other: Patient Experience

Interventions

Pharmacological education OTHER

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.

Adherence to drug treatment; Patient experience

Training in the use of MyPlan Aplication OTHER

Review of the use of the aplication

Adherence to drug treatment; Patient experience

Patient Experience OTHER

* How do you feel? * Sad feelings and frustration. * Achievements day by day, think positive. * Importance of interpersonal relationships. * Explain activities to relax the mind

Patient experience; Positive mental health

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of femur fracture
• knowledge of the Spanish language
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Amgen: collaborator
• University of Barcelona: collaborator

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Femoral Fractures; Medication Adherence; Psychological Well-Being

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Personal Satisfaction

Study Officials

• Carmen Moreno Arroyo

  UB

  STUDY DIRECTOR

Central Study Contacts

Gemma Marcos Anton

CONTACT

+34657915371; gmarcos@clinic.cat

Montserrat Puig LLobet

CONTACT

+34934035510; monpuigllob@ub.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 30, 2022
• Study Start: November 21, 2022
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: December 30, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: February 2024
• Access Criteria: Healthcare professionals

Locations

ES (1)