Heart TransplantationNCT02938676
Satisfaction Degree in a Nurse Educational Program to Heart Transplant Patient
An observational study of Heart Transplantation and Health Education, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
Any member of the research team conducted screening for the selection of eligible patients. Nurses will be responsible for delivering the "Guide tips for the person with a transplanted heart", thus initiating an individualized education program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplantation, Health Education
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Mar 2018
- Phase
- Observational
- 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
Study population: Patients Unit hospitalization of Cardiology (B3) of the Hospital de la Santa Creu i Sant Pau (HSCSP) that during admission require surgery Heart Transplantation. Convenience sampling in which eligible patients will be selected to participate in the study consecutively according to the time of admission to the inpatient
Who may be able to join
- Patients of both sexes, over 18 years.
- With medical diagnosis of heart transplant surgery during the same hospitalization.
- They must have a "primary caregiver" or a report favorable social support.
Who cannot join
- Medical diagnosis of cognitive impairment (Alzheimer's disease, senile dementia, neurological problem).
- Illiteracy and / or language barrier.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Satisfaction Degree With the Education Received in an Educational Program to Heart Transplant Patient During Hospitalization
Any member of the research team conducted screening for the selection of eligible patients. Nurses will be responsible for delivering the "Guide tips for the person with a transplanted heart", thus initiating an individualized education program. Education will be held at the time of admission in which the patient has passed the most critical post-operative.
Educational tips guide contains all the information necessary for the patient to have a first contact on the habits that must change. Education lasts 10-30 minutes and is taught in daytime, in a calm environment and at the right time, favoring the presence of the caregiver. Later, education is reinforced on the doubts that arise both the patient and the primary caregiver.
Read more
During the first days of admission to the unit of cardiology, socio-demographic data of the patient and primary caregiver by the research team will be collected.
A few days before discharge, having left time between 7-8 days after delivery of educational advice guide, any member of the research team, who does not work in the cardiology unit, will provide the patient and the primary caregiver the satisfaction questionnaire where the perception of information and education received during the postoperative period in the inpatient cardiology unit and the appropriateness of the topics covered in the guide educational advice.
Read the detailed description
- Conceptual Definition: Result of the difference between what the patient / caregiver expected to happen (patient expectations) and what claims to have obtained (their perception of the experience, the service provided) 14, 15.
- Operational Definition: To assess the degree of satisfaction has designed a self-administered questionnaire specific for this study in which the following items were evaluated:
- Knowledge of the name and profession of the person performing the educational activity.
- Time used to provide educational session.
- Adequacy of time spent by nurses.
- At which has been given the educational session.
- Educational information received.
- Documentation provided.
- Understanding the information provided.
- Specific content by topics (general information, diet, hygiene measures, mood, exercise and cardiac rehabilitation, sexual activity, complications, skin, eye, gastrointestinal tract, bones, toxic habits, vaccination, contact other people, animals and plants, travel, employment high, associations heart transplant recipients).
- Satisfaction with education received
The overall satisfaction score is obtained from the sum of the scores of all items and a cut will be established from data obtained from median scores in a previous pilot survey conducted using 5 patients. The overall satisfaction score can range from 0 to 120 points.
- Conditions
- Heart Transplantation, Health Education
- Medical subject headings
- Health Education
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction by a a self-administered questionnaire specific to this study
It will be evaluated:
- Knowledge of the name and profession of the person performing the educational activity.
- Time used to provide educational session.
- Adequacy of time spent by nurses.
- At which has been given the educational session.
- Educational information received.
- Documentation provided.
- Understanding the information provided.
- Specific content by topics
- Satisfaction with education received in general The overall satisfaction score is obtained from the sum of the scores of all items and a cut will be established from data obtained from median scores in a previous pilot survey conducted using 5 patients. The overall satisfaction score can range from 0 to 120 points.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alba Villalobos Abelló, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938676
- Sponsor's protocol ID
- IIBSP-SAT-2016-44
- Status last verified
- Oct 2016
- First submitted
- 10 Oct 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction Degree With the Education Received in an Educational Program to Heart Transplant Patient During Hospitalization
- ClinicalTrials.gov ID
- NCT02938676
- Acronym / sponsor ID
- IIBSP-SAT-2016-44
- Conditions
- Heart Transplantation, Health Education
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 19 Oct 2016 (estimated)
- 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.
Any member of the research team conducted screening for the selection of eligible patients. Nurses will be responsible for delivering the "Guide tips for the person with a transplanted heart", thus initiating an individualized education program. Education will be held at the time of admission in which the patient has passed the most critical post-operative.
Educational tips guide contains all the information necessary for the patient to have a first contact on the habits that must change. Education lasts 10-30 minutes and is taught in daytime, in a calm environment and at the right time, favoring the presence of the caregiver. Later, education is reinforced on the doubts that arise both the patient and the primary caregiver.
During the first days of admission to the unit of cardiology, socio-demographic data of the patient and primary caregiver by the research team will be collected.
A few days before discharge, having left time between 7-8 days after delivery of educational advice guide, any member of the research team, who does not work in the cardiology unit, will provide the patient and the primary caregiver the satisfaction questionnaire where the perception of information and education received during the postoperative period in the inpatient cardiology unit and the appropriateness of the topics covered in the guide educational advice.
Detailed description
- Conceptual Definition: Result of the difference between what the patient / caregiver expected to happen (patient expectations) and what claims to have obtained (their perception of the experience, the service provided) 14, 15.
- Operational Definition: To assess the degree of satisfaction has designed a self-administered questionnaire specific for this study in which the following items were evaluated:
- Knowledge of the name and profession of the person performing the educational activity.
- Time used to provide educational session.
- Adequacy of time spent by nurses.
- At which has been given the educational session.
- Educational information received.
- Documentation provided.
- Understanding the information provided.
- Specific content by topics (general information, diet, hygiene measures, mood, exercise and cardiac rehabilitation, sexual activity, complications, skin, eye, gastrointestinal tract, bones, toxic habits, vaccination, contact other people, animals and plants, travel, employment high, associations heart transplant recipients).
- Satisfaction with education received
The overall satisfaction score is obtained from the sum of the scores of all items and a cut will be established from data obtained from median scores in a previous pilot survey conducted using 5 patients. The overall satisfaction score can range from 0 to 120 points.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Unit hospitalization of Cardiology (B3) of the Hospital de la Santa Creu i Sant Pau (HSCSP) that during admission require surgery Heart Transplantation. Convenience sampling in which eligible patients will be selected to participate in the study consecutively according to the time of admission to the inpatient
Key inclusion criteria (3 listed)
- Patients of both sexes, over 18 years.
- With medical diagnosis of heart transplant surgery during the same hospitalization.
- They must have a "primary caregiver" or a report favorable social support.
Key exclusion criteria (2 listed)
- Medical diagnosis of cognitive impairment (Alzheimer's disease, senile dementia, neurological problem).
- Illiteracy and / or language barrier.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient satisfaction by a a self-administered questionnaire specific to this study
Time frame: 1 year
It will be evaluated: 1. Knowledge of the name and profession of the person performing the educational activity. 2. Time used to provide educational session. 3. Adequacy of time spent by nurses. 4. At which has been given the educational session. 5. Educational information received. 6. Documentation provided. 7. Understanding the information provided. 8. Specific content by topics 9. Satisfaction with education received in general The overall satisfaction score is obtained from the sum of the scores of all items and a cut will be established from data obtained from median scores in a previous pilot survey conducted using 5 patients. The overall satisfaction score can range from 0 to 120 points.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Alba Villalobos Abelló principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplantation and Health Education, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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 3 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 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Alba Villalobos Abelló (+34617196845, avillalobos@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction by a a self-administered questionnaire specific to this study (time frame: 1 year). 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 19 Oct 2016.