Self AdministrationNCT06228716
Education With Hybrid Simulation Method in Patients Administering Subcutaneous Biological Drugs
A study testing Training with hybrid simulation method and Broshure in people with Self Administration and Biological Therapy, run by İlayda Türkoğlu at 1 site in Turkey (Türkiye).
Trial summary
In recent years, vital drugs such as heparin, insulin, growth hormone, interferons, monoclonal antibodies and drugs containing proteins that can be destroyed in the gastrointestinal tract have been developed in the form of self-subcutaneous injection in order to reduce the negative effects of treatment practices on… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Self Administration, Biological Therapy, Training
- What is being tested?
- Training with hybrid simulation method and Broshure
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jul 2021to 1 Sep 2022
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 18-50,
- Residing in Istanbul,
- Their family/relatives are not using medication in subcutaneous injection form,
- Receiving injection training for the first time,
- First time injection application,
- Using biological medication for the first time,
Show all 13Show fewer
- Using subcutaneous biological medication for the first time,
- The requested subcutaneous biological drug must be in pen form,
- The drug administration dose should be once every 2 weeks (1/14),
- Being open to communication and cooperation,
- No experience of injecting any living creature (human or animal),
- There is no cognitive, perceptual, or physical disability that would hinder the ability to administer self-injection,
- Volunteering to participate in the research.
Who cannot join
- Leaving the study at any stage of the research process,
- Not participating in the training and evaluations included in the research,
- Having any local or systemic infectious disease at any stage of the research process.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Üsküdar, İ̇stanbul
About this study
Official title: The Effect of the Training Given by Hybrid Simulation Method on The Skill and Anxiety Level of the Patients Applying Subcutaneous Biological Drugs
In recent years, vital drugs such as heparin, insulin, growth hormone, interferons, monoclonal antibodies and drugs containing proteins that can be destroyed in the gastrointestinal tract have been developed in the form of self-subcutaneous injection in order to reduce the negative effects of treatment practices on the lives of patients. After the training, the patients can apply the subcutaneous injection on their own without assistance. This situation reduces the dependency on the nurse and allows the patient to apply the injection on time, without the need to reach the health institutions. In a study, it is stated that the inadequacy of injection training causes many patients to develop inappropriate injection behavior patterns and to acquire habits regarding these inappropriate techniques. It is also stated that the anxiety they experienced before the injection caused them to ignore the critical steps towards the injection application. In this study, the Subcutaneous Injection Hybrid Model, developed by the researcher, will be used in the training of patients who administer biologic drugs subcutaneously. It is thought that these patients will improve their injection practice skills and reduce their anxiety about injection by repetitive applications by training with the hybrid simulation method.
Read the detailed description
A poor self-injection experience can lead to undesirable treatment outcomes. However, increasing morbidity and mortality rates are closely related to non-adherence to treatment. Undesirable results due to non-compliance with treatment lead to more visits to emergency services, prolongation of inpatient treatments and increased surgical interventions, thus increasing the workload and costs of health services. In addition, patients who cannot receive repeated and effective training on subcutaneous injection application cause them to experience anxiety about subcutaneous drug administration on their own, and often come to health units only for subcutaneous injection, due to the limited ability to administer. This situation can both negatively affect the daily life activities and self-efficacy perceptions of the patients and increase the workload and cost in health services.
Hybrid Simulation; It is also defined as "patient-centered simulation". In this method; Simulated/standardized patient method is used together with auxiliary tools. Wearable simulation tools are used in this simulation type. When the literature is examined, it is seen that various training methods for self-administration skills are used in patients followed in the rheumatology outpatient clinic, but their effectiveness is controversial. In addition, no study has been found to evaluate the effectiveness of a hybrid simulation-based training on the improvement of application skills and reduction of anxiety regarding subcutaneous injection of biologic drugs, for which adherence to treatment is vital. The aim of this study is to evaluate the effect of training given by simulation method on patients who administer subcutaneous biologic drugs on their application skills and anxiety level. It is thought that these patients, who are trained with the hybrid simulation method, will decrease their negative experiences of subcutaneous biologic drug administration by repetitive applications and incorrect drug administration due to misunderstandings, their injection administration skills will improve, and their anxiety about injection will decrease.
Purpose and Design of the Research
This study was planned in a pre-test-post-test randomized controlled design in order to evaluate the effect of the training given by the hybrid simulation method to the patients who administered subcutaneous biologic drugs on the application skill and anxiety level.
- Conditions
- Self Administration, Biological Therapy, Training
- Being tested
- Training with hybrid simulation method, Broshure
- Keywords
- Self administratation, anxiety, subcutaneous injection, biological therapy, simulation training
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with hybrid simulation methodDevice
Subcutaneous biological drug self-administration training was given by the researcher in two stages, theoretical and practical, face to face. Power point presentation and training brochure were used in theoretical training. The practical training given after the theoretical training was given using the Hybrid simulation method. The Wearable Subcutaneous Injection Hybrid Simulator developed by the researcher was worn by the individuals after being informed about its purpose and function. Afterwards, they were expected to apply the subcutaneous application step by step as explained to them. Each application step they made incorrectly was corrected and repeated with the support of the researcher. The application was considered successful if they completed all application steps correctly from start to finish. The training took approximately 40 minutes. After the practical training, the individuals' questions, if any, were answered and the training was terminated.
BroshureOther
Subcutaneous biological drug self-administration training was given theoretically face to face by the researcher using a power point presentation and training brochure. The training lasted approximately 25 minutes and was given in the same room where the experimental group received training. After the training, any questions the individuals had were answered and the training was ended.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Subcutaneous biological drug self-administration training was given by the researcher in two stages, theoretical and practical, face to face. Power point presentation and training brochure were used in theoretical training. The practical training given after the theoretical training was given using the Hybrid simulation method. The Wearable Subcutaneous Injection Hybrid Simulator developed by the researcher was worn by the individuals after being informed about its purpose and function. A medicine pen similar to their own medicine pens (demo pen without medicine), dry cotton, alcohol swab (similar to the ones that come in medicine pen boxes), and a small notepad and pen were left in a clean medicine tray on a clean table. Afterwards, they were expected to apply the subcutaneous application step by step as explained to them. Each application step they made incorrectly was corrected and repeated with the support of the researcher.The training took approximately 40 minutes. Receives: Device: Training with hybrid simulation method |
| Kontrol Group | Other | Subcutaneous biological drug self-administration training was given theoretically face to face by the researcher using a power point presentation and training brochure. The training lasted approximately 25 minutes and was given in the same room where the experimental group received training. Receives: Other: Broshure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
It was structured by the researcher in line with the literature and included demographic information such as "the individual's name, surname, age, gender, marital status, education level" as well as "medical diagnosis, the name of the subcutaneous medication used and whether he/she has received any simulation-based training before and his phone number." It consisted of 11 questions including ".
Measured: Before training
Determination of state anxiety level/pretest application
All individuals in both the experimental and control groups included in the sample were asked to fill out the State Anxiety Scale to evaluate their anxiety levels before the subcutaneous biological drug administration training.
Measured: Before training and 2. week before first self administration of subcutaneous injection by the patient
Subcutaneous Biological Drug Self-Administration Skill Checklist
Checklist consisting of 20 application steps to evaluate the skill level of Subcutaneous Biological Drug Self-Administration
Measured: 1. week post training; 2. week post training
Secondary outcomes (3)
Subcutaneous Biological Drug Knowledge Test
17-item test assessing the level of knowledge about subcutaneous biological drugs
Measured: 1. week post training
Patient Education Evaluation Survey
5-point Likert-type survey consisting of 10 items on patients' evaluation of education
Measured: 1. week post training
Trait anxiety scale
20-item scale assessing an individual's trait anxiety. trait anxiety scale
Measured: 1. week post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start2 Jul 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Self AdministrationStudies 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
- The research was carried out with a pretest-posttest randomized controlled experimental design to evaluate the effect of the training given by the hybrid simulation method to individuals who self-administer subcutaneous biological drugs on application skills and anxiety levels.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- İlayda Türkoğlu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, İlayda Türkoğlu, Saglik Bilimleri Universitesi
- Investigators
- İlayda Türkoğlu, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228716
- Sponsor's protocol ID
- 10840098-772.02-E.60612
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stenger F, Konig A, Ochsendorf F, Kaufmann R, Pinter A. Correct performance of subcutaneous injections in plaque psoriasis: comparison of trained and untrained patients with different application systems in routine clinical care. J Dermatolog Treat. 2021 Dec;32(8):898-906. doi: 10.1080/09546634.2020.1720580. Epub 2020 Feb 2.
PubMed 32009495Timmermann H, Mailander C. Home Self-Administration of Biologics - A German Survey among Omalizumab-Treated Patients with Severe Asthma and their Treating Physicians. Pneumologie. 2020 Feb;74(2):103-111. doi: 10.1055/a-1069-0900. Epub 2020 Jan 9.
PubMed 31935761Fischer-Cartlidge E, Romanoff S, Thom B, Burrows Walters C. Comparing Self-Injection Teaching Strategies for Patients With Breast Cancer and Their Caregivers: A Pilot Study. Clin J Oncol Nurs. 2016 Oct 1;20(5):515-21. doi: 10.1188/16.CJON.515-521.
PubMed 27668371
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Training Given by Hybrid Simulation Method on The Skill and Anxiety Level of the Patients Applying Subcutaneous Biological Drugs
- ClinicalTrials.gov ID
- NCT06228716
- Acronym / sponsor ID
- 10840098-772.02-E.60612
- Conditions
- Self Administration, Biological Therapy, Training
- Keywords
- Self administratation, anxiety, subcutaneous injection, biological therapy, simulation training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- İlayda TürkoğluUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 29 Jan 2024 (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.
In recent years, vital drugs such as heparin, insulin, growth hormone, interferons, monoclonal antibodies and drugs containing proteins that can be destroyed in the gastrointestinal tract have been developed in the form of self-subcutaneous injection in order to reduce the negative effects of treatment practices on the lives of patients. After the training, the patients can apply the subcutaneous injection on their own without assistance. This situation reduces the dependency on the nurse and allows the patient to apply the injection on time, without the need to reach the health institutions. In a study, it is stated that the inadequacy of injection training causes many patients to develop inappropriate injection behavior patterns and to acquire habits regarding these inappropriate techniques. It is also stated that the anxiety they experienced before the injection caused them to ignore the critical steps towards the injection application. In this study, the Subcutaneous Injection Hybrid Model, developed by the researcher, will be used in the training of patients who administer biologic drugs subcutaneously. It is thought that these patients will improve their injection practice skills and reduce their anxiety about injection by repetitive applications by training with the hybrid simulation method.
Detailed description
A poor self-injection experience can lead to undesirable treatment outcomes. However, increasing morbidity and mortality rates are closely related to non-adherence to treatment. Undesirable results due to non-compliance with treatment lead to more visits to emergency services, prolongation of inpatient treatments and increased surgical interventions, thus increasing the workload and costs of health services. In addition, patients who cannot receive repeated and effective training on subcutaneous injection application cause them to experience anxiety about subcutaneous drug administration on their own, and often come to health units only for subcutaneous injection, due to the limited ability to administer. This situation can both negatively affect the daily life activities and self-efficacy perceptions of the patients and increase the workload and cost in health services.
Hybrid Simulation; It is also defined as "patient-centered simulation". In this method; Simulated/standardized patient method is used together with auxiliary tools. Wearable simulation tools are used in this simulation type. When the literature is examined, it is seen that various training methods for self-administration skills are used in patients followed in the rheumatology outpatient clinic, but their effectiveness is controversial. In addition, no study has been found to evaluate the effectiveness of a hybrid simulation-based training on the improvement of application skills and reduction of anxiety regarding subcutaneous injection of biologic drugs, for which adherence to treatment is vital. The aim of this study is to evaluate the effect of training given by simulation method on patients who administer subcutaneous biologic drugs on their application skills and anxiety level. It is thought that these patients, who are trained with the hybrid simulation method, will decrease their negative experiences of subcutaneous biologic drug administration by repetitive applications and incorrect drug administration due to misunderstandings, their injection administration skills will improve, and their anxiety about injection will decrease.
Purpose and Design of the Research
This study was planned in a pre-test-post-test randomized controlled design in order to evaluate the effect of the training given by the hybrid simulation method to the patients who administered subcutaneous biologic drugs on the application skill and anxiety level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research was carried out with a pretest-posttest randomized controlled experimental design to evaluate the effect of the training given by the hybrid simulation method to individuals who self-administer subcutaneous biological drugs on application skills and anxiety levels.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Training with hybrid simulation methodSubcutaneous biological drug self-administration training was given by the researcher in two stages, theoretical and practical, face to face. Power point presentation and training brochure were used in theoretical training. The practical training given after the theoretical training was given using the Hybrid simulation method. The Wearable Subcutaneous Injection Hybrid Simulator developed by the researcher was worn by the individuals after being informed about its purpose and function. A medicine pen similar to their own medicine pens (demo pen without medicine), dry cotton, alcohol swab (similar to the ones that come in medicine pen boxes), and a small notepad and pen were left in a clean medicine tray on a clean table. Afterwards, they were expected to apply the subcutaneous application step by step as explained to them. Each application step they made incorrectly was corrected and repeated with the support of the researcher.The training took approximately 40 minutes. |
| Kontrol Group | Other | Other: BroshureSubcutaneous biological drug self-administration training was given theoretically face to face by the researcher using a power point presentation and training brochure. The training lasted approximately 25 minutes and was given in the same room where the experimental group received training. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Being between the ages of 18-50,
- Residing in Istanbul,
- Their family/relatives are not using medication in subcutaneous injection form,
- Receiving injection training for the first time,
- First time injection application,
Key exclusion criteria (3 listed)
- Leaving the study at any stage of the research process,
- Not participating in the training and evaluations included in the research,
- Having any local or systemic infectious disease at any stage of the research process.
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 |
|---|---|---|
| Training with hybrid simulation methodSubcutaneous biological drug self-administration training was given by the researcher in two stages, theoretical and practical, face to face. Power point presentation and training brochure were used in theoretical training. The practical training given after the theoretical training was given using the Hybrid simulation method. The Wearable Subcutaneous Injection Hybrid Simulator developed by the researcher was worn by the individuals after being informed about its purpose and function. Afterwards, they were expected to apply the subcutaneous application step by step as explained to them. Each application step they made incorrectly was corrected and repeated with the support of the researcher. The application was considered successful if they completed all application steps correctly from start to finish. The training took approximately 40 minutes. After the practical training, the individuals' questions, if any, were answered and the training was terminated. | Device | Experimental |
| BroshureSubcutaneous biological drug self-administration training was given theoretically face to face by the researcher using a power point presentation and training brochure. The training lasted approximately 25 minutes and was given in the same room where the experimental group received training. After the training, any questions the individuals had were answered and the training was ended. | Other | Kontrol Group |
Primary outcome
Patient Information Form
Time frame: Before training
It was structured by the researcher in line with the literature and included demographic information such as "the individual's name, surname, age, gender, marital status, education level" as well as "medical diagnosis, the name of the subcutaneous medication used and whether he/she has received any simulation-based training before and his phone number." It consisted of 11 questions including ".
Determination of state anxiety level/pretest application
Time frame: Before training and 2. week before first self administration of subcutaneous injection by the patient
All individuals in both the experimental and control groups included in the sample were asked to fill out the State Anxiety Scale to evaluate their anxiety levels before the subcutaneous biological drug administration training.
Subcutaneous Biological Drug Self-Administration Skill Checklist
Time frame: 1. week post training; 2. week post training
Checklist consisting of 20 application steps to evaluate the skill level of Subcutaneous Biological Drug Self-Administration
3 secondary outcomes
Subcutaneous Biological Drug Knowledge Test
Time frame: 1. week post training
Patient Education Evaluation Survey
Time frame: 1. week post training
Trait anxiety scale
Time frame: 1. week post training
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 29 Jan 2024.
- Background: PubMed 32009495Stenger F, Konig A, Ochsendorf F, Kaufmann R, Pinter A. Correct performance of subcutaneous injections in plaque psoriasis: comparison of trained and untrained patients with different application systems in routine clinical care. J Dermatolog Treat. 2021 Dec;32(8):898-906. doi: 10.1080/09546634.2020.1720580. Epub 2020 Feb 2.
- Background: PubMed 31935761Timmermann H, Mailander C. Home Self-Administration of Biologics - A German Survey among Omalizumab-Treated Patients with Severe Asthma and their Treating Physicians. Pneumologie. 2020 Feb;74(2):103-111. doi: 10.1055/a-1069-0900. Epub 2020 Jan 9.
- Results publication: PubMed 27668371Fischer-Cartlidge E, Romanoff S, Thom B, Burrows Walters C. Comparing Self-Injection Teaching Strategies for Patients With Breast Cancer and Their Caregivers: A Pilot Study. Clin J Oncol Nurs. 2016 Oct 1;20(5):515-21. doi: 10.1188/16.CJON.515-521.
- Individual participant dataSharing planned: No
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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.
İlayda Türkoğlu study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training with hybrid simulation method and Broshure in people with Self Administration and Biological Therapy, run by İlayda Türkoğlu 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 13 inclusion and 3 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 29 Jan 2024. 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?
Patient Information Form (time frame: Before training). The study lists 3 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 NCT06228716, which also lists 3 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 29 Jan 2024.