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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05669040
Enrollment
278
Registered
2022-12-30
Start date
2022-11-21
Completion date
2023-04-30
Last updated
2022-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture of Femur

Keywords

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

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.

Interventions

OTHERPharmacological 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.

OTHERTraining in the use of MyPlan Aplication

Review of the use of the aplication

OTHERPatient 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

Sponsors

Amgen
CollaboratorINDUSTRY
University of Barcelona
CollaboratorOTHER
Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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%.

Countries

Spain

Contacts

Primary ContactGemma Marcos Anton
gmarcos@clinic.cat+34657915371
Backup ContactMontserrat Puig LLobet
monpuigllob@ub.edu+34934035510

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026