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

Not Applicable

Recruiting

• Conditions: Fracture of Femur
• Interventions: Other: Patient Experience; Other: Pharmacological education; Other: Training in the use of MyPlan Aplication

• Registration Number: NCT05669040
• Lead Sponsor: Hospital Clinic of Barcelona

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.

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 Timeline

• Study Start: 2022-11-21
• Status Verified: 2022-12
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-29
• Last Update Submitted: 2022-12-29
• Study First Posted: 2022-12-30
• Last Update Posted: 2022-12-30
• Primary Completion: 2023-01
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 278

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Positive mental health	Patient Experience	-
Adherence to drug treatment	Training in the use of MyPlan Aplication	-
Patient experience	Training in the use of MyPlan Aplication	-
Patient experience	Pharmacological education	-
Patient experience	Patient Experience	-
Adherence to drug treatment	Pharmacological education	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain