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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02938676
Other study ID # IIBSP-SAT-2016-44
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 10, 2016
Last updated October 18, 2016
Start date November 2016
Est. completion date March 2018

Study information

Verified date October 2016
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact Alba Villalobos Abelló
Phone +34617196845
Email avillalobos@santpau.cat
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Observational

Clinical 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. 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.


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:

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 (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).

9. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date March 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Medical diagnosis of cognitive impairment (Alzheimer's disease, senile dementia, neurological problem).

- Illiteracy and / or language barrier.

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
1 year Yes
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