During the Pandemic Process the Focus is on Developing a Training ProgramNCT05192967
Development and Efficiency Evaluation of a Respiratory Disease Pandemics Preparedness Training Program for Pre-Hospital Emergency Healthcare Workers
A study testing Pandemic preparedness via video and Pandemic preparedness via classical method in people with During the Pandemic Process the Focus is on Developing a Training Program, run by Seval Çalışkan Pala at 1 site in Turkey (Türkiye).
Trial summary
Pre-hospital emergency health workers, who are on the front line among healthcare workers, are at greater risk in epidemic situations, as they are the first team to come into contact with the patient and are responsible for making necessary interventions by staying in close contact with the patient during the transfer… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- During the Pandemic Process the Focus is on Developing a Training Program
- What is being tested?
- Pandemic preparedness via video and Pandemic preparedness via classical method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 5 May 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University
Eskişehir, 26200
About this study
Pre-hospital emergency health workers, who are on the front line among healthcare workers, are at greater risk in epidemic situations, as they are the first team to come into contact with the patient and are responsible for making necessary interventions by staying in close contact with the patient during the transfer process (1, 2). Health workers need to improve their knowledge, attitudes and skills during the pandemic process; on the other hand, they experience mental and communicative problems more strikingly. It is essential to increase the continuity of development, mental resilience, and communication of healthcare professionals(3). A randomised controlled study was planned to prepare a training program to improve pre-hospital emergency health workers' knowledge, attitudes, and skills about pandemic preparations and evaluate its effectiveness.
The intervention study was conducted among pre-hospital emergency health workers in Eskişehir between July 2020 and December 2021. Ethics committee approval and administrative permissions were obtained. In the study, when the type 1 (α) error was 5%, and the type 2 error (1-β) was 95%, the effect size was accepted as 0.5, and it was calculated with the G*Power 3.1 statistical program that there should be at least 47 people in the groups. The study population consists of paramedics and emergency medical technicians(EMT) (N=420) in Eskişehir city, Turkey. Each participant in the study population was given a score by propensity score matching analysis according to age, gender, occupational group (paramedic and EMT), working time (year) variables. The study list was arranged according to the initials of their surnames, and the drawing method was used while assigning those with similar scores to four groups (experimental 1, experimental 2, control 1, control 2). Four groups, two interventions and two controls, were included in the study.
Read more
The work consisted of five stages:
- Determining the needs in education,
- Development of educational materials,
- Making pre-training measurements,
- Implementation of the training program,
- Performing post-training measurements. As a result of the evaluation, the subjects that healthcare professionals need to train were determined as knowledge, attitude, skills, infection control measures, communication skills, psychological resilience and attitudes of healthcare professionals to the patient in a simulated case and pandemic. The appropriate data collection form was chosen after the training program's content was determined. Before the intervention, the first measurements were taken via the COVID-19 knowledge, attitude, skills, and perceived barriers to infection control questionnaire, the communication competence scale, the psychological resilience scale, and the data collection form, including the simulated case approach. After the training program's content was determined, training was given to the intervention group with a video screening and the control group with the classical training method. After the training program, a post-test was applied after a four-week follow-up.
Read the detailed description
The intervention study was conducted among pre-hospital emergency health workers in Eskişehir between July 2020 and December 2021. Ethics committee approval and administrative permissions were obtained. In the study, when the type 1 (α) error was 5%, and the type 2 error (1-β) was 95%, the effect size was accepted as 0.5, and it was calculated with the G*Power 3.1 statistical program that there should be at least 47 people in the groups. The study population consists of paramedics and emergency medical technicians (N=420) in Eskişehir city, Turkey. Each participant in the study population was given a score by propensity score matching analysis according to age, gender, occupational group (paramedic and ATT), working time (year) variables. The study list was arranged according to the initials of their surnames, and the drawing method was used while assigning those with similar scores to four groups (experimental 1, experimental 2, control 1, control 2). Four groups, two interventions and two controls, were included in the study. The work consisted of five stages:
- Determining the needs in education,
- Development of educational materials,
- making pre-training measurements,
- Implementation of the training program,
- Performing post-training measurements. As a result of the evaluation, the training needs of healthcare professionals were determined as knowledge, attitude, skills, infection control measures, communication skills, psychological resilience and approach to COVID-19 positive case. After the training program's content was determined, training was given to the intervention group with a video screening and the control group with the classical training method.
Measurement tools used in the study:
- Questionnaire on knowledge, skills, attitudes and perceived barriers in infection control about COVID-19: Adapting the questionnaire named "Knowledge, attitude, practice and perception barriers among healthcare professionals regarding COVID-19", developed by Saqlain et al., into Turkish, and conducting a reliability and validity study It was made by Caliskan Pala et al. in 2021 (4, 5).
- Simulated case checklist: It was created to evaluate the case approach of healthcare professionals during the pandemic process. The template of events for applied and critical healthcare simulation (Teach Sim) and The Simulation team assessment tool (STAT) created simulated cases. According to START, which is the most widely used triage system, a total of 111 cases were developed, with cases according to green, yellow, and red triage codes. (6). The approach of each participant to a COVID-19 positive case with a green code ( Minor injuries), one yellow ( Non-life-threatening injury ), and one red ( Life-threatening injury ) was evaluated. Each scenario consisted of six steps, 20 questions regarding infection control measures, patient history and physical examination, preliminary diagnosis, medical intervention, communication, and delivering the patient to the health institution. Each item on the scale was scored according to its completion status. The score that can be obtained according to the number of questions in the steps was standardised.
- communication skills: This scale, which aims to measure the communication skills of individuals in general, was developed by Wiemann in 1977 and adapted into Turkish by Koca and Erigüç in 2017 (7, 8). The scale consists of eight sub-dimensions: "Social Behavior Competence", "Individual aspects in communication", "Empathy competency", "Adaptability", "Sensitivity Competence", "Communication Encouragement Competence", "Human Relations", "Listening Competence".
- psychological resilience: The scale was developed by Friborg et al. in 2003, and Basım and Çetin established Turkish validity and reliability in 2011 (9, 10). The structural style consists of six sub-areas: future perception, family harmony, self-perception, and social competence.
Hypotheses:
- Is the pandemic preparedness training program effective in developing knowledge, attitudes and skills in pre-hospital emergency health workers compared to the control group trained with the classical method?
- Is the pandemic preparedness training program effective in developing communication competence in prehospital emergency health workers compared to the control group trained with the classical method?
- Is the pandemic preparedness training program effective in developing psychological resilience in prehospital emergency health workers compared to the control group trained with the classical method?
- Being tested
- Pandemic preparedness via video, Pandemic preparedness via classical method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pandemic preparedness via videoBehavioural
A training program created by experts on knowledge, attitude, skills, simulated case approach, communication between the patient and the team, and psychological resilience about COVID-19 was implemented with a video demonstration.
Pandemic preparedness via classical methodBehavioural
A training program created by experts on knowledge, attitude, skills, simulated case approach, communication between the patient and the team, and psychological resilience about COVID-19 was implemented with a classical method.
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | The training program determined to the experimental group was applied with video. Training program content:
1. Knowledge, attitude, skills about COVID-19
2. Approach to the COVID-19 positive case
3. Communication skills
4. Psychological resilience Receives: Behavioral: Pandemic preparedness via video |
| Experimental 2 | Experimental | The training program determined to the experimental group was applied with video.
Training program content:
1. Knowledge, attitude, skills about COVID-19
2. Approach to the COVID-19 positive case
3. Communication skills
4. Psychological resilience Receives: Behavioral: Pandemic preparedness via video |
| Control 1 | Other | The training program determined to the control group was applied with classical method.
Training program content:
1. Knowledge, attitude, skills about COVID-19
2. Approach to the COVID-19 positive case
3. Communication skills
4. Psychological resilience Receives: Behavioral: Pandemic preparedness via classical method |
| Control 2 | Other | The training program determined to the control group was applied with classical method.
Training program content:
1. Knowledge, attitude, skills about COVID-19
2. Approach to the COVID-19 positive case
3. Communication skills
4. Psychological resilience Receives: Behavioral: Pandemic preparedness via classical method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge, attitude, practice and perceived barriers among healthcare workers regarding COVID-19 Questionnaire
Measured: One month
Simulated case checklist
Measured: One month
Communication skills
Measurement was made with the communication competence scale
Measured: One month
Psychological resilience
Measurement was made with the psychological resilience scale
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Mar 2021
- Primary completion15 Apr 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for During the Pandemic Process the Focus is on Developing a Training ProgramStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seval Çalışkan Pala
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seval Çalışkan Pala, Eskisehir Osmangazi University
- Investigators
- Seval CALISKAN PALA, Study director, ESOGUSelma METİNTAS, Principal investigator, ESOGUEngin OZAKIN, Study chair, ESOGU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192967
- Sponsor's protocol ID
- EskisehirOU99
- Status last verified
- Dec 2021
- First submitted
- 14 Dec 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Efficiency Evaluation of a Respiratory Disease Pandemics Preparedness Training Program for Pre-Hospital Emergency Healthcare Workers
- ClinicalTrials.gov ID
- NCT05192967
- Acronym / sponsor ID
- EskisehirOU99
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Seval Çalışkan PalaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 14 Jan 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.
Pre-hospital emergency health workers, who are on the front line among healthcare workers, are at greater risk in epidemic situations, as they are the first team to come into contact with the patient and are responsible for making necessary interventions by staying in close contact with the patient during the transfer process (1, 2). Health workers need to improve their knowledge, attitudes and skills during the pandemic process; on the other hand, they experience mental and communicative problems more strikingly. It is essential to increase the continuity of development, mental resilience, and communication of healthcare professionals(3). A randomised controlled study was planned to prepare a training program to improve pre-hospital emergency health workers' knowledge, attitudes, and skills about pandemic preparations and evaluate its effectiveness.
The intervention study was conducted among pre-hospital emergency health workers in Eskişehir between July 2020 and December 2021. Ethics committee approval and administrative permissions were obtained. In the study, when the type 1 (α) error was 5%, and the type 2 error (1-β) was 95%, the effect size was accepted as 0.5, and it was calculated with the G*Power 3.1 statistical program that there should be at least 47 people in the groups. The study population consists of paramedics and emergency medical technicians(EMT) (N=420) in Eskişehir city, Turkey. Each participant in the study population was given a score by propensity score matching analysis according to age, gender, occupational group (paramedic and EMT), working time (year) variables. The study list was arranged according to the initials of their surnames, and the drawing method was used while assigning those with similar scores to four groups (experimental 1, experimental 2, control 1, control 2). Four groups, two interventions and two controls, were included in the study.
The work consisted of five stages:
- Determining the needs in education,
- Development of educational materials,
- Making pre-training measurements,
- Implementation of the training program,
- Performing post-training measurements. As a result of the evaluation, the subjects that healthcare professionals need to train were determined as knowledge, attitude, skills, infection control measures, communication skills, psychological resilience and attitudes of healthcare professionals to the patient in a simulated case and pandemic. The appropriate data collection form was chosen after the training program's content was determined. Before the intervention, the first measurements were taken via the COVID-19 knowledge, attitude, skills, and perceived barriers to infection control questionnaire, the communication competence scale, the psychological resilience scale, and the data collection form, including the simulated case approach. After the training program's content was determined, training was given to the intervention group with a video screening and the control group with the classical training method. After the training program, a post-test was applied after a four-week follow-up.
Detailed description
The intervention study was conducted among pre-hospital emergency health workers in Eskişehir between July 2020 and December 2021. Ethics committee approval and administrative permissions were obtained. In the study, when the type 1 (α) error was 5%, and the type 2 error (1-β) was 95%, the effect size was accepted as 0.5, and it was calculated with the G*Power 3.1 statistical program that there should be at least 47 people in the groups. The study population consists of paramedics and emergency medical technicians (N=420) in Eskişehir city, Turkey. Each participant in the study population was given a score by propensity score matching analysis according to age, gender, occupational group (paramedic and ATT), working time (year) variables. The study list was arranged according to the initials of their surnames, and the drawing method was used while assigning those with similar scores to four groups (experimental 1, experimental 2, control 1, control 2). Four groups, two interventions and two controls, were included in the study. The work consisted of five stages:
- Determining the needs in education,
- Development of educational materials,
- making pre-training measurements,
- Implementation of the training program,
- Performing post-training measurements. As a result of the evaluation, the training needs of healthcare professionals were determined as knowledge, attitude, skills, infection control measures, communication skills, psychological resilience and approach to COVID-19 positive case. After the training program's content was determined, training was given to the intervention group with a video screening and the control group with the classical training method.
Measurement tools used in the study:
- Questionnaire on knowledge, skills, attitudes and perceived barriers in infection control about COVID-19: Adapting the questionnaire named "Knowledge, attitude, practice and perception barriers among healthcare professionals regarding COVID-19", developed by Saqlain et al., into Turkish, and conducting a reliability and validity study It was made by Caliskan Pala et al. in 2021 (4, 5).
- Simulated case checklist: It was created to evaluate the case approach of healthcare professionals during the pandemic process. The template of events for applied and critical healthcare simulation (Teach Sim) and The Simulation team assessment tool (STAT) created simulated cases. According to START, which is the most widely used triage system, a total of 111 cases were developed, with cases according to green, yellow, and red triage codes. (6). The approach of each participant to a COVID-19 positive case with a green code ( Minor injuries), one yellow ( Non-life-threatening injury ), and one red ( Life-threatening injury ) was evaluated. Each scenario consisted of six steps, 20 questions regarding infection control measures, patient history and physical examination, preliminary diagnosis, medical intervention, communication, and delivering the patient to the health institution. Each item on the scale was scored according to its completion status. The score that can be obtained according to the number of questions in the steps was standardised.
- communication skills: This scale, which aims to measure the communication skills of individuals in general, was developed by Wiemann in 1977 and adapted into Turkish by Koca and Erigüç in 2017 (7, 8). The scale consists of eight sub-dimensions: "Social Behavior Competence", "Individual aspects in communication", "Empathy competency", "Adaptability", "Sensitivity Competence", "Communication Encouragement Competence", "Human Relations", "Listening Competence".
- psychological resilience: The scale was developed by Friborg et al. in 2003, and Basım and Çetin established Turkish validity and reliability in 2011 (9, 10). The structural style consists of six sub-areas: future perception, family harmony, self-perception, and social competence.
Hypotheses:
- Is the pandemic preparedness training program effective in developing knowledge, attitudes and skills in pre-hospital emergency health workers compared to the control group trained with the classical method?
- Is the pandemic preparedness training program effective in developing communication competence in prehospital emergency health workers compared to the control group trained with the classical method?
- Is the pandemic preparedness training program effective in developing psychological resilience in prehospital emergency health workers compared to the control group trained with the classical method?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Behavioral: Pandemic preparedness via videoThe training program determined to the experimental group was applied with video. Training program content: 1. Knowledge, attitude, skills about COVID-19 2. Approach to the COVID-19 positive case 3. Communication skills 4. Psychological resilience |
| Experimental 2 | Experimental | Behavioral: Pandemic preparedness via videoThe training program determined to the experimental group was applied with video. Training program content: 1. Knowledge, attitude, skills about COVID-19 2. Approach to the COVID-19 positive case 3. Communication skills 4. Psychological resilience |
| Control 1 | Other | Behavioral: Pandemic preparedness via classical methodThe training program determined to the control group was applied with classical method. Training program content: 1. Knowledge, attitude, skills about COVID-19 2. Approach to the COVID-19 positive case 3. Communication skills 4. Psychological resilience |
| Control 2 | Other | Behavioral: Pandemic preparedness via classical methodThe training program determined to the control group was applied with classical method. Training program content: 1. Knowledge, attitude, skills about COVID-19 2. Approach to the COVID-19 positive case 3. Communication skills 4. Psychological resilience |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Pandemic preparedness via videoA training program created by experts on knowledge, attitude, skills, simulated case approach, communication between the patient and the team, and psychological resilience about COVID-19 was implemented with a video demonstration. | Behavioural | Experimental 1, Experimental 2 |
| Pandemic preparedness via classical methodA training program created by experts on knowledge, attitude, skills, simulated case approach, communication between the patient and the team, and psychological resilience about COVID-19 was implemented with a classical method. | Behavioural | Control 1, Control 2 |
Primary outcome
Knowledge, attitude, practice and perceived barriers among healthcare workers regarding COVID-19 Questionnaire
Time frame: One month
Simulated case checklist
Time frame: One month
Communication skills
Time frame: One month
Measurement was made with the communication competence scale
Psychological resilience
Time frame: One month
Measurement was made with the psychological resilience scale
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 14 Jan 2022.
- Individual participant dataSharing planned: Undecided
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.
Seval CALISKAN PALA study director
ESOGU
Selma METİNTAS principal investigator
ESOGU
Engin OZAKIN study chair
ESOGU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pandemic preparedness via video and Pandemic preparedness via classical method in people with During the Pandemic Process the Focus is on Developing a Training Program, run by Seval Çalışkan Pala at 1 site in Turkey (Türkiye).
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 0 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 14 Jan 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 Turkey (Türkiye). 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?
Knowledge, attitude, practice and perceived barriers among healthcare workers regarding COVID-19 Questionnaire (time frame: One month). The study lists 4 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 14 Jan 2022.