Fracture of FemurNCT05669040
mHealth to Improve the Experience, Adherence to Drug Treatment and Positive Mental Health
A study testing Pharmacological education, Training in the use of MyPlan Aplication and Patient Experience in people with Fracture of Femur, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Femur
- What is being tested?
- Pharmacological education, Training in the use of MyPlan Aplication and Patient Experience
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteSpain
- Study dates
- 21 Nov 2022to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- presence of psychological pathologies or cognitive impairment
- isolation in hospital admission
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
Gemma Marcos, +34657915371, gmarcos@clinic.cat
About this study
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
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.
Read the 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.
- Conditions
- Fracture of Femur
- Being tested
- Pharmacological education, Training in the use of MyPlan Aplication, Patient Experience
- Keywords
- education, patient experience, adherence medication, mental health, mobile health, nurse, mHealth, protocol
- Medical subject headings
- Femoral Fractures, Medication Adherence, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacological educationOther
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 AplicationOther
Review of the use of the aplication
Patient ExperienceOther
- How do you feel?
- Sad feelings and frustration.
- Achievements day by day, think positive.
- Importance of interpersonal relationships.
- Explain activities to relax the mind
| Study group | Role | What they receive |
|---|---|---|
| Patient experience | Active comparator | Not described Receives: Other: Pharmacological education; Other: Training in the use of MyPlan Aplication; Other: Patient Experience |
| Adherence to drug treatment | Active comparator | Not described Receives: Other: Pharmacological education; Other: Training in the use of MyPlan Aplication |
| Positive mental health | Active comparator | Not described Receives: Other: Patient Experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 1rst day (before intervention), at 7th day (at discharge after intervention), and 25th day (after discharge)
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.
Measured: at 1rst day, at 7th day and 25th day.
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%.
Measured: at 1rst day, at 7th day and 25th day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start21 Nov 2022
- Primary completionJan 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of FemurStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, University of Barcelona
- Responsible party
- Principal investigator, Gemma Marcos, Hospital Clinic of Barcelona
- Investigators
- Carmen Moreno Arroyo, Study director, UB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669040
- Sponsor's protocol ID
- Intervention EFE
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05669040
- Acronym / sponsor ID
- Intervention EFE
- Conditions
- Fracture of Femur
- Keywords
- education, patient experience, adherence medication, mental health, mobile health, nurse, mHealth, protocol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Amgen, University of Barcelona
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 30 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient experience | Active comparator | Other: Pharmacological education, Other: Training in the use of MyPlan Aplication, Other: Patient Experience |
| Adherence to drug treatment | Active comparator | Other: Pharmacological education, Other: Training in the use of MyPlan Aplication |
| Positive mental health | Active comparator | Other: Patient Experience |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- presence of psychological pathologies or cognitive impairment
- isolation in hospital admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacological educationInform 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 | Adherence to drug treatment, Patient experience |
| Training in the use of MyPlan AplicationReview of the use of the aplication | Other | Adherence to drug treatment, Patient experience |
| 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 | Other | Patient experience, Positive mental health |
Primary outcome
Patient experience questionnaire-15. Changes in outcomes are assessed at three time points.
Time frame: 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.
Time frame: 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.
Time frame: 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%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Individual participant dataSharing planned: Yes. * 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Moreno Arroyo study director
UB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacological education, Training in the use of MyPlan Aplication and Patient Experience in people with Fracture of Femur, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gemma Marcos Anton (+34657915371, gmarcos@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient experience questionnaire-15. Changes in outcomes are assessed at three time points. (time frame: at 1rst day (before intervention), at 7th day (at discharge after intervention), and 25th day (after discharge)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2022.