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

NCT ID: NCT05669040

Last Updated: 2022-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-21

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fracture of Femur

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient experience

Group Type ACTIVE_COMPARATOR

Pharmacological education

Intervention Type 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.

Training in the use of MyPlan Aplication

Intervention Type OTHER

Review of the use of the aplication

Patient Experience

Intervention Type 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

Adherence to drug treatment

Group Type ACTIVE_COMPARATOR

Pharmacological education

Intervention Type 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.

Training in the use of MyPlan Aplication

Intervention Type OTHER

Review of the use of the aplication

Positive mental health

Group Type ACTIVE_COMPARATOR

Patient Experience

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Training in the use of MyPlan Aplication

Review of the use of the aplication

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Amgen

INDUSTRY

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gemma Marcos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carmen Moreno Arroyo

Role: STUDY_DIRECTOR

UB

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gemma Marcos Anton

Role: CONTACT

Phone: +34657915371

Email: [email protected]

Montserrat Puig LLobet

Role: CONTACT

Phone: +34934035510

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gemma Marcos

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Intervention EFE

Identifier Type: -

Identifier Source: org_study_id