TracheostomyNCT05434442
Caregivers Tracheal Aspiration Training
A study testing simulation model training and mobile app training in people with Tracheostomy and Family Caregivers, run by Uludag University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effects of animation-based mobile application and simulation-based training methods on tracheal aspiration knowledge and skills of patient relatives who care for patients with tracheostomy/tracheotomy. Experimental pre-test-post-test control group study design was planned. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tracheostomy, Family Caregivers, Aspiration
- What is being tested?
- simulation model training and mobile app training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Jun 2022to 10 Aug 2023
- 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
- Being the primary caregiver of the patient who will undergo a tracheotomy or tracheostomy, which is expected to last at least one month,
- Primary care will be continued by the same caregiver for a period of one month.
- Volunteering to participate in the research
- Being over 18 years old,
- Absence of a diagnosed psychiatric illness that may interfere with communication
- Owning and being able to use a smart mobile phone
Who cannot join
- Not being the primary caregiver of the patient who will undergo tracheostomy or tracheotomy,
- Change of primary caregiver in less than a month
- Closing the tracheotomy in less than a month
- Not volunteering to participate in the research
- Be under the age of 18,
- Having a diagnosed psychiatric illness that may interfere with communication
- Not having or being unable to use a smart mobile phone
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Yeliz
Bursa, Nilüfer
Bursa Uludag university
Bursa, 16000
About this study
Official title: Evaluation of the Effectiveness of the Simulation Model and Mobile Application in Teaching Tracheostomy Aspiration Application to the Caregivers of Patients With Tracheostomy and Tracheotomy
The aim of this study is to determine the effects of animation-based mobile application and simulation-based training methods on tracheal aspiration knowledge and skills of patient relatives who care for patients with tracheostomy/tracheotomy. Experimental pre-test-post-test control group study design was planned.
Read the detailed description
The study aims to determine the effect of tracheal aspiration training given to caregivers of patients with tracheostomy and tracheotomy. The effects of training given using clinical routine training, animation-based mobile application and simulation-based training methods on the knowledge and skills of caregivers will be evaluated. Experimental pre-test-post-test control group study design was planned. This study will be carried out as a multicenter in Bursa, Turkey.The centers where the study will be conducted are Bursa Uludağ University Health Research and Application Center and Bursa City Hospital. In calculating the sample size, the effect size was determined as 0.4 for 80% power and 5% significance level. In this direction, it is aimed to include 22 patient relatives in each group in order to compare the knowledge and skill levels between the mobile application, simulation training and control groups. A total of 66 patient relatives will be included in the study. The caregivers to be assigned to the groups will be selected using the block randomized method.
The plan to be implemented in the research;
- Pre-Training: "Introductory Characteristics Form" and "Information Evaluation Form" will be filled in for caregivers in all groups.
- Training: An animation-based mobile application will be installed on the phones of the caregivers assigned to the "mobile application group" and will be introduced and made available to their use by the researcher Yeliz ŞAPULU ALAKAN. Tracheal aspiration training of caregivers assigned to the "simulation training group" will be given to the same standard by researcher Yeliz ŞAPULU ALAKAN. It will be shown in practice on the tracheostomy care simulator. Caregivers assigned to the "control group" will not undergo any training other than routine in-clinic training on tracheostomy aspiration. Caregivers in the all group will also undergo routine training of the clinic
- After the training: Caregivers in all groups will fill out the "Training Evaluation Form" and "Information Evaluation Form." The video of the caregiver taken during the tracheal aspiration procedure will be evaluated by the researchers using the "Skill Evaluation Form".
- One month after the training: Caregivers in all groups will fill in the "Information Evaluation Form" and "Result Evaluation Form".The video of the caregiver taken during the tracheal aspiration procedure will be evaluated by the researchers using the "Skill Evaluation Form".
- Conditions
- Tracheostomy, Family Caregivers, Aspiration
- Being tested
- simulation model training, mobile app training, control group
- Keywords
- Family Caregivers, Tracheostomy aspiration, Mobile application, Simulation training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation model trainingOther
Tracheal aspiration training of caregivers assigned to the "simulation training group" will be given to the same standard by researcher. It will be shown in practice on the tracheostomy care simulator.
mobile app trainingOther
An animation-based mobile application will be installed on the phones of the caregivers assigned to the "mobile application group" and will be introduced and made available to their use by the researcher.
control groupOther
Clinical routine training will be given to caregivers in this group.
| Study group | Role | What they receive |
|---|---|---|
| 1-simulation model training | Other | Tracheal aspiration training of caregivers assigned to the "simulation training group" will be given to the same standard by researcher. It will be shown in practice on the tracheostomy care simulator. They will also receive clinical routine training Receives: Other: simulation model training; Other: control group |
| 2-mobile app training | Other | An animation-based mobile application will be installed on the phones of the caregivers assigned to the "mobile application group" and will be introduced and made available to their use by the researcher. They will also receive clinical routine training Receives: Other: mobile app training; Other: control group |
| 3-control group | Other | Clinical routine training will be given to caregivers in this group. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effects of simulation model, mobile application and routine training methods on the knowledge scores of the caregivers of patients with tracheostomy before the training, after the training and one month after the training.
Getting at least 50 points from each part of the "knowledge evaluation form", which includes questions about the procedure.
Measured: through study completion, an average of 1 year
To determine the effects of simulation model, mobile application and routine training methods on the skill levels of caregivers of patients with tracheostomy before, after and one month after training.
Caregivers will be evaluated according to the "skill evaluation form" during the aspiration process from the tracheostomy.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Satisfaction with different training methods
To be measured using the "Satisfaction Evaluation Form"
Measured: through study completion, an average of 1 year
One month after the different trainings, the effects of caregivers on the aspiration application will be evaluated using the "Results Evaluation Form".
The effect of different training methods will be evaluated.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start3 Jun 2022
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Caregivers will be assigned to control, simulation and mobile application groups by block randomization method. An equal number of caregivers from each clinic will be assigned to each group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Sapulu Alakan, Uludag University
- Investigators
- yeliz Şapulu Alakan, Principal investigator, Uludag UniverstyNeriman Akansel, Study director, Uludag Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434442
- Sponsor's protocol ID
- Uludag Universty
- Status last verified
- Nov 2023
- First submitted
- 14 Jun 2022
- Last updated
- 4 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
Bayram SB, Caliskan N. Effect of a game-based virtual reality phone application on tracheostomy care education for nursing students: A randomized controlled trial. Nurse Educ Today. 2019 Aug;79:25-31. doi: 10.1016/j.nedt.2019.05.010. Epub 2019 May 9.
PubMed 31102793Loerzel VW, Crosby WW, Reising E, Sole ML. Developing the Tracheostomy Care Anxiety Relief Through Education and Support (T-CARES) Program. Clin J Oncol Nurs. 2014 Oct;18(5):522-7. doi: 10.1188/14.CJON.522-527.
PubMed 25253106
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Simulation Model and Mobile Application in Teaching Tracheostomy Aspiration Application to the Caregivers of Patients With Tracheostomy and Tracheotomy
- ClinicalTrials.gov ID
- NCT05434442
- Acronym / sponsor ID
- Uludag Universty
- Conditions
- Tracheostomy, Family Caregivers, Aspiration
- Keywords
- Family Caregivers, Tracheostomy aspiration, Mobile application, Simulation training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 28 Jun 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.
The aim of this study is to determine the effects of animation-based mobile application and simulation-based training methods on tracheal aspiration knowledge and skills of patient relatives who care for patients with tracheostomy/tracheotomy. Experimental pre-test-post-test control group study design was planned.
Detailed description
The study aims to determine the effect of tracheal aspiration training given to caregivers of patients with tracheostomy and tracheotomy. The effects of training given using clinical routine training, animation-based mobile application and simulation-based training methods on the knowledge and skills of caregivers will be evaluated. Experimental pre-test-post-test control group study design was planned. This study will be carried out as a multicenter in Bursa, Turkey.The centers where the study will be conducted are Bursa Uludağ University Health Research and Application Center and Bursa City Hospital. In calculating the sample size, the effect size was determined as 0.4 for 80% power and 5% significance level. In this direction, it is aimed to include 22 patient relatives in each group in order to compare the knowledge and skill levels between the mobile application, simulation training and control groups. A total of 66 patient relatives will be included in the study. The caregivers to be assigned to the groups will be selected using the block randomized method.
The plan to be implemented in the research;
- Pre-Training: "Introductory Characteristics Form" and "Information Evaluation Form" will be filled in for caregivers in all groups.
- Training: An animation-based mobile application will be installed on the phones of the caregivers assigned to the "mobile application group" and will be introduced and made available to their use by the researcher Yeliz ŞAPULU ALAKAN. Tracheal aspiration training of caregivers assigned to the "simulation training group" will be given to the same standard by researcher Yeliz ŞAPULU ALAKAN. It will be shown in practice on the tracheostomy care simulator. Caregivers assigned to the "control group" will not undergo any training other than routine in-clinic training on tracheostomy aspiration. Caregivers in the all group will also undergo routine training of the clinic
- After the training: Caregivers in all groups will fill out the "Training Evaluation Form" and "Information Evaluation Form." The video of the caregiver taken during the tracheal aspiration procedure will be evaluated by the researchers using the "Skill Evaluation Form".
- One month after the training: Caregivers in all groups will fill in the "Information Evaluation Form" and "Result Evaluation Form".The video of the caregiver taken during the tracheal aspiration procedure will be evaluated by the researchers using the "Skill Evaluation Form".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Caregivers will be assigned to control, simulation and mobile application groups by block randomization method. An equal number of caregivers from each clinic will be assigned to each group.
| Arm | Type | Receives |
|---|---|---|
| 1-simulation model training | Other | Other: simulation model training, Other: control groupTracheal aspiration training of caregivers assigned to the "simulation training group" will be given to the same standard by researcher. It will be shown in practice on the tracheostomy care simulator. They will also receive clinical routine training |
| 2-mobile app training | Other | Other: mobile app training, Other: control groupAn animation-based mobile application will be installed on the phones of the caregivers assigned to the "mobile application group" and will be introduced and made available to their use by the researcher. They will also receive clinical routine training |
| 3-control group | Other | Other: control groupClinical routine training will be given to caregivers in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being the primary caregiver of the patient who will undergo a tracheotomy or tracheostomy, which is expected to last at least one month,
- Primary care will be continued by the same caregiver for a period of one month.
- Volunteering to participate in the research
- Being over 18 years old,
- Absence of a diagnosed psychiatric illness that may interfere with communication
Key exclusion criteria (7 listed)
- Not being the primary caregiver of the patient who will undergo tracheostomy or tracheotomy,
- Change of primary caregiver in less than a month
- Closing the tracheotomy in less than a month
- Not volunteering to participate in the research
- Be under the age of 18,
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 |
|---|---|---|
| simulation model trainingTracheal aspiration training of caregivers assigned to the "simulation training group" will be given to the same standard by researcher. It will be shown in practice on the tracheostomy care simulator. | Other | 1-simulation model training |
| mobile app trainingAn animation-based mobile application will be installed on the phones of the caregivers assigned to the "mobile application group" and will be introduced and made available to their use by the researcher. | Other | 2-mobile app training |
| control groupClinical routine training will be given to caregivers in this group. | Other | 1-simulation model training, 2-mobile app training, 3-control group |
Primary outcome
To determine the effects of simulation model, mobile application and routine training methods on the knowledge scores of the caregivers of patients with tracheostomy before the training, after the training and one month after the training.
Time frame: through study completion, an average of 1 year
Getting at least 50 points from each part of the "knowledge evaluation form", which includes questions about the procedure.
To determine the effects of simulation model, mobile application and routine training methods on the skill levels of caregivers of patients with tracheostomy before, after and one month after training.
Time frame: through study completion, an average of 1 year
Caregivers will be evaluated according to the "skill evaluation form" during the aspiration process from the tracheostomy.
2 secondary outcomes
Satisfaction with different training methods
Time frame: through study completion, an average of 1 year
One month after the different trainings, the effects of caregivers on the aspiration application will be evaluated using the "Results Evaluation Form".
Time frame: through study completion, an average of 1 year
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 4 Dec 2023.
- Background: PubMed 31102793Bayram SB, Caliskan N. Effect of a game-based virtual reality phone application on tracheostomy care education for nursing students: A randomized controlled trial. Nurse Educ Today. 2019 Aug;79:25-31. doi: 10.1016/j.nedt.2019.05.010. Epub 2019 May 9.
- Background: PubMed 25253106Loerzel VW, Crosby WW, Reising E, Sole ML. Developing the Tracheostomy Care Anxiety Relief Through Education and Support (T-CARES) Program. Clin J Oncol Nurs. 2014 Oct;18(5):522-7. doi: 10.1188/14.CJON.522-527.
- Guidelines for the Care of Patients with Tracheostomy TubesLink provided by the sponsor.
- A Caregiver Guide for Tracheostomy Care at HomeLink provided by the sponsor.
- Tracheostomy Teachıng Package For Parents And Carers Assessment.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. all collected IPD
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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.
yeliz Şapulu Alakan principal investigator
Uludag Universty
Neriman Akansel study director
Uludag Universty
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simulation model training and mobile app training in people with Tracheostomy and Family Caregivers, run by Uludag University at 2 sites 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 6 inclusion and 7 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 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To determine the effects of simulation model, mobile application and routine training methods on the knowledge scores of the caregivers of patients with tracheostomy before the training, after the training and one month after the training. (time frame: through study completion, an average of 1 year). 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?
On the ClinicalTrials.gov record for NCT05434442, which also lists 2 linked publications.
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 4 Dec 2023.