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

Primary Purpose

Fracture of Femur

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pharmacological education
Training in the use of MyPlan Aplication
Patient Experience
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fracture of Femur focused on measuring education, patient experience, adherence medication, mental health, mobile health, nurse, mHealth, protocol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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. Exclusion Criteria: presence of psychological pathologies or cognitive impairment isolation in hospital admission

Sites / Locations

  • Hospital Clinic de BarcelonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Patient experience

Adherence to drug treatment

Positive mental health

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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%.

Secondary Outcome Measures

Full Information

First Posted
December 2, 2022
Last Updated
December 29, 2022
Sponsor
Hospital Clinic of Barcelona
Collaborators
Amgen, University of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT05669040
Brief Title
mHealth to Improve the Experience, Adherence to Drug Treatment and Positive Mental Health
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Amgen, University of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Femur
Keywords
education, patient experience, adherence medication, mental health, mobile health, nurse, mHealth, protocol

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
278 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient experience
Arm Type
Active Comparator
Arm Title
Adherence to drug treatment
Arm Type
Active Comparator
Arm Title
Positive mental health
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Pharmacological education
Intervention Description
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
Intervention Name(s)
Training in the use of MyPlan Aplication
Intervention Description
Review of the use of the aplication
Intervention Type
Other
Intervention Name(s)
Patient Experience
Intervention Description
How do you feel? Sad feelings and frustration. Achievements day by day, think positive. Importance of interpersonal relationships. Explain activities to relax the mind
Primary Outcome Measure Information:
Title
Patient experience questionnaire-15. Changes in outcomes are assessed at three time points.
Description
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.
Time Frame
at 1rst day (before intervention), at 7th day (at discharge after intervention), and 25th day (after discharge)
Title
Morinski-Green Questionnaire. Changes in outcomes are assessed at three time points.
Description
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.
Time Frame
at 1rst day, at 7th day and 25th day.
Title
Positive Mental Health Questionnaire. Changes in outcomes are assessed at three time points.
Description
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%.
Time Frame
at 1rst day, at 7th day and 25th day.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gemma Marcos Anton
Phone
+34657915371
Email
gmarcos@clinic.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Montserrat Puig LLobet
Phone
+34934035510
Email
monpuigllob@ub.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Moreno Arroyo
Organizational Affiliation
UB
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gemma Marcos
Phone
+34657915371
Email
gmarcos@clinic.cat

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication of an article with preliminary results in the BioMed Central Public Health magazine. Presentation of results at National Congress of Mental Health Nursing. Spain. Publication of results article in "Revista Española de Enfermería de Salud Mental" magazine. Presentation of results at Investen, Annual Meeting on Care Research. Spain.
IPD Sharing Time Frame
February 2024
IPD Sharing Access Criteria
Healthcare professionals

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

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