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Sevice-learning in Physiotherapy and Heart Transplantation and Acute Coronary Syndrome

Primary Purpose

Heart Transplantation

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Service-learning program
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Transplantation

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Physiotherapy students

Exclusion Criteria:

  • Prior courses on cardiac rehabilitation

Sites / Locations

  • University of Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Service-learning group

Control group

Arm Description

Intervention group will perform a service-learning program with real patients with heart transplantation and coronary syndrome, and will have to perform a physical therapy program adapted to a real patient. Two meetings will be performed in order to establish groups, explain the project and search information based on evidence in scientific databases. In addition, three meetings with patients will be stated in order to establish the adapted program based on the real patient's needs and characteristics.

Control group will perform a physical therapy program for heart transplantation and coronary syndrome, but without meeting real patients. One meeting will be performed in order to establish groups and search information based on evidence in scientific databases.

Outcomes

Primary Outcome Measures

Ethical sensitivity
Ethical sensitivity Questionnaire, composed of of 9 items with six possible responses (Likert scale from 1, indicating total disagreement, to 6, indicating total agreement). The minimum score is 9 and the maximum score is 54. The more score, the more ethical sensitivity. Cronbach's alpha=0.76
Ethical sensitivity
Ethical sensitivity Questionnaire, composed of of 9 items with six possible responses (Likert scale from 1, indicating total disagreement, to 6, indicating total agreement). The minimum score is 9 and the maximum score is 54. The more score, the more ethical sensitivity. Cronbach's alpha=0.76

Secondary Outcome Measures

Service performed (by the students of the experimental group)
Service-learning Questionnaire, using the part of the questionnaire about service
Skills acquired (by the students of the experimental group)
Service-learning Questionnaire, using the part of the questionnaire about skills
Participation (of the students of the experimental group)
Service-learning Questionnaire,using the part of the questionnaire about participation
Degree of participatory evaluation (of the students of the experimental group)
Questionnaire of Participatory evaluation, Service-learning and university
Level of satisfaction (of the students of the experimental group)
ad-hoc satisfaction questionnaire
Knowledge on physiotherapy in heart transplantation
A 10-question test exam will be created ad-hoc
Knowledge on physiotherapy in heart transplantation
A 10-question test exam will be created ad-hoc
Acquired transversal competences
Questionnaire of Higher education, transversal skills and gender, consisted of 6 items about gender and competencies (Likert scale of 7 points: level 4 was set as neutral, scores above 4 were considered positive, and those below 4 were taken as negative scores)
Acquired transversal competences
Questionnaire of Higher education, transversal skills and gender, consisted of 6 items about gender and competencies (Likert scale of 7 points: level 4 was set as neutral, scores above 4 were considered positive, and those below 4 were taken as negative scores)

Full Information

First Posted
January 2, 2019
Last Updated
April 16, 2021
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT04261998
Brief Title
Sevice-learning in Physiotherapy and Heart Transplantation and Acute Coronary Syndrome
Official Title
The Effects of Sevice-learning in Physiotherapy Students: Exercise Program for Patients With Heart Transplantation and Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

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

5. Study Description

Brief Summary
A service-learning programme in physiotherapy students will be performed. 30 physiotherapy students will be randomly assigned to an intervention group (n=16) or to a control group (n=16). Intervention group will perform a service-learning program with real patients with heart transplantation, and will have to perform a physical therapy program adapted to a real patient. Two meetings will be performed in order to establish groups, explain the project and search information based on evidence in scientific databases. In addition, three meetings with patients will be stated in order to establish the adapted program based on the real patient's needs and characteristics. The control group will have to perform a physiotherapy program without meeting real patients.
Detailed Description
This study aims at determining the effect of a Service-Learning program on knowledge, ethical sensitivity and acquired transversal competences. On the other hand, we aim at evaluating the service performed, the skills acquired, the participation, the degree of participatory evaluation and the level of satisfaction of the intervention group. All variables will be measured with validated scales or questionnaires. Both groups will have to describe the specific characteristics of the program, different phases of the process, types of exercises recommended, contraindications, safety ranges with respect to the intensity of the exercise, ways of calculating the intensity and self-control. Likewise, they will have to defend the usefulness and duration of the final product through an oral presentation of the program to the patients themselves. Finally, the possible doubts that should exist will be solved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Service-learning group
Arm Type
Experimental
Arm Description
Intervention group will perform a service-learning program with real patients with heart transplantation and coronary syndrome, and will have to perform a physical therapy program adapted to a real patient. Two meetings will be performed in order to establish groups, explain the project and search information based on evidence in scientific databases. In addition, three meetings with patients will be stated in order to establish the adapted program based on the real patient's needs and characteristics.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will perform a physical therapy program for heart transplantation and coronary syndrome, but without meeting real patients. One meeting will be performed in order to establish groups and search information based on evidence in scientific databases.
Intervention Type
Other
Intervention Name(s)
Service-learning program
Intervention Description
Intervention group will perform a service-learning program with real patients with heart transplantation, and will have to perform a physical therapy program adapted to a real patient. Two meetings will be performed in order to establish groups, explain the project and search information based on evidence in scientific databases. In addition, three meetings with patients will be stated in order to establish the adapted program based on the real patient's needs and characteristics.
Primary Outcome Measure Information:
Title
Ethical sensitivity
Description
Ethical sensitivity Questionnaire, composed of of 9 items with six possible responses (Likert scale from 1, indicating total disagreement, to 6, indicating total agreement). The minimum score is 9 and the maximum score is 54. The more score, the more ethical sensitivity. Cronbach's alpha=0.76
Time Frame
baseline
Title
Ethical sensitivity
Description
Ethical sensitivity Questionnaire, composed of of 9 items with six possible responses (Likert scale from 1, indicating total disagreement, to 6, indicating total agreement). The minimum score is 9 and the maximum score is 54. The more score, the more ethical sensitivity. Cronbach's alpha=0.76
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Service performed (by the students of the experimental group)
Description
Service-learning Questionnaire, using the part of the questionnaire about service
Time Frame
3 months
Title
Skills acquired (by the students of the experimental group)
Description
Service-learning Questionnaire, using the part of the questionnaire about skills
Time Frame
3 months
Title
Participation (of the students of the experimental group)
Description
Service-learning Questionnaire,using the part of the questionnaire about participation
Time Frame
3 months
Title
Degree of participatory evaluation (of the students of the experimental group)
Description
Questionnaire of Participatory evaluation, Service-learning and university
Time Frame
3 months
Title
Level of satisfaction (of the students of the experimental group)
Description
ad-hoc satisfaction questionnaire
Time Frame
3 months
Title
Knowledge on physiotherapy in heart transplantation
Description
A 10-question test exam will be created ad-hoc
Time Frame
baseline
Title
Knowledge on physiotherapy in heart transplantation
Description
A 10-question test exam will be created ad-hoc
Time Frame
3 months
Title
Acquired transversal competences
Description
Questionnaire of Higher education, transversal skills and gender, consisted of 6 items about gender and competencies (Likert scale of 7 points: level 4 was set as neutral, scores above 4 were considered positive, and those below 4 were taken as negative scores)
Time Frame
baseline
Title
Acquired transversal competences
Description
Questionnaire of Higher education, transversal skills and gender, consisted of 6 items about gender and competencies (Likert scale of 7 points: level 4 was set as neutral, scores above 4 were considered positive, and those below 4 were taken as negative scores)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Physiotherapy students Exclusion Criteria: Prior courses on cardiac rehabilitation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Marques-Sule, PT, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

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Sevice-learning in Physiotherapy and Heart Transplantation and Acute Coronary Syndrome

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