Heart TransplantationNCT04261998
Sevice-learning in Physiotherapy and Heart Transplantation and Acute Coronary Syndrome
A study testing Service-learning program in people with Heart Transplantation, run by University of Valencia at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- Service-learning program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2020to 31 Jul 2020
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physiotherapy students
Who cannot join
- Prior courses on cardiac rehabilitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Sevice-learning in Physiotherapy Students: Exercise Program for Patients With Heart Transplantation and Acute Coronary Syndrome
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.
Read the 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.
- Conditions
- Heart Transplantation
- Being tested
- Service-learning program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Service-learning programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Service-learning group | Experimental | 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. Receives: Other: Service-learning program |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
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
Measured: 3 months
Secondary outcomes (9)
Service performed (by the students of the experimental group)
Service-learning Questionnaire, using the part of the questionnaire about service
Measured: 3 months
Skills acquired (by the students of the experimental group)
Service-learning Questionnaire, using the part of the questionnaire about skills
Measured: 3 months
Participation (of the students of the experimental group)
Service-learning Questionnaire,using the part of the questionnaire about participation
Measured: 3 months
Degree of participatory evaluation (of the students of the experimental group)
Questionnaire of Participatory evaluation, Service-learning and university
Measured: 3 months
Level of satisfaction (of the students of the experimental group)
ad-hoc satisfaction questionnaire
Measured: 3 months
Knowledge on physiotherapy in heart transplantation
A 10-question test exam will be created ad-hoc
Measured: baseline
Knowledge on physiotherapy in heart transplantation
A 10-question test exam will be created ad-hoc
Measured: 3 months
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)
Measured: baseline
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Mar 2020
- Primary completion1 Jun 2020
- Study completion31 Jul 2020
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 University of ValenciaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Marques-Sule, University of Valencia
- Investigators
- Elena Marques-Sule, PT, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261998
- Sponsor's protocol ID
- H1542195894247
- Status last verified
- Apr 2021
- First submitted
- 2 Jan 2019
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sevice-learning in Physiotherapy Students: Exercise Program for Patients With Heart Transplantation and Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04261998
- Acronym / sponsor ID
- H1542195894247
- Conditions
- Heart Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 10 Feb 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Service-learning group | Experimental | Other: Service-learning programIntervention 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 | No intervention | –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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Physiotherapy students
Key exclusion criteria (1 listed)
- Prior courses on cardiac rehabilitation
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 |
|---|---|---|
| Service-learning programIntervention 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. | Other | Service-learning group |
Primary outcome
Ethical sensitivity
Time frame: baseline
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
Time frame: 3 months
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
9 secondary outcomes
Service performed (by the students of the experimental group)
Time frame: 3 months
Skills acquired (by the students of the experimental group)
Time frame: 3 months
Participation (of the students of the experimental group)
Time frame: 3 months
Degree of participatory evaluation (of the students of the experimental group)
Time frame: 3 months
Level of satisfaction (of the students of the experimental group)
Time frame: 3 months
Knowledge on physiotherapy in heart transplantation
Time frame: baseline
Knowledge on physiotherapy in heart transplantation
Time frame: 3 months
Acquired transversal competences
Time frame: baseline
Acquired transversal competences
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
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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.
Elena Marques-Sule, PT, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Service-learning program in people with Heart Transplantation, run by University of Valencia 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ethical sensitivity (time frame: baseline). The study lists 2 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 20 Apr 2021.