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

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Recruiting

CT.gov ID

NCT05669040

Collaborator

Amgen (Industry), University of Barcelona (Other)

278

Enrollment

Location

Arms

4.3

Anticipated Duration (Months)

64.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fracture of Femur	Other: Pharmacological education Other: Training in the use of MyPlan Aplication Other: Patient Experience	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

278 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Nov 21, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.
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.
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%.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.