ChatbotNCT06544421
The Impact of Chatbot-Assisted Nursing Education on Perceived Burden of Care and Caregiver Stress
A study testing Assigned Interventions in people with Chatbot and Anxiety, run by Ataturk University.
Trial summary
Caregivers play a key role in the provision of day-to-day care and the coordination of care services. Caregivers of stroke patients use dysfunctional coping strategies to cope with the stressors and burden of care they encounter during this long caregiving process. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chatbot, Anxiety, Depression
- What is being tested?
- Assigned Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2024to 31 Jul 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To be at least a primary school graduate
- Caregivers have the cognitive capacity to use chatbots (The chatbot application will be installed on the caregiver's android phone and the status of using it will be evaluated)
- Willingness to participate in the study
- To be open to communication and cooperation
- Having a phone with Android operating system
- Have literacy skills
- Not having participated in stress training before
Who cannot join
- Having received any psychiatric diagnosis.
- Taking antipsychotic medication
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Chatbot-Assisted Nursing Education on Perceived Care Burden and Caregiver Stress
Caregivers play a key role in the provision of day-to-day care and the coordination of care services. Caregivers of stroke patients use dysfunctional coping strategies to cope with the stressors and burden of care they encounter during this long caregiving process. In this study, it will be tried to improve the stress coping skills of caregivers by using an application with chatbot support based on the COM-B model.In the study, introductory information form, stress coping styles scale, depression, anxiety, stress (DASS 21) and burden of care measurement tool will be used. The study will be conducted in a randomized controlled manner. Chatbot will be applied to the experimental group and the control group will be exposed to routine practice. The study group will consist of individuals who care for those who are discharged home from Atatürk University stroke center. Experiments and controls will be accessed by searching the hospital records. The fact that nursing education is given through a chatbot and that the chatbot is designed according to a stress training model (behavior change wheel) reflects the originality of the study. With this study, caregivers are expected to be able to manage stress effectively by teaching them how to cope with stress.
Read the detailed description
gree relatives who care for the patients who receive 3-5 points from the Modified Rankin Scale will be discharged from the stroke center of the Neurology Clinic of Atatürk University Health Research and Application Center located in the city center of Erzurum.With the expectation of a 50 percent reduction in the rate of stressed patients in the intervention group and a 10 percent decrease in the control group, it was decided to include 31 people in each group with 90 percent power and 5 percent type 1 error. The sample calculation was calculated using the open epi version 3.01 web interface.It is expected that the implementation and reporting of the research will take 2 years. Year 1 Preparation of chatbot and determination of experimental controls. Implementation of training. Collection of results and writing of the report in 1 year.
The caregivers included in the experimental group will be told about the study and their written consent will be obtained. Individuals in the experimental group will be asked to apply the data collection forms prepared before the use of the application is explained. After the pre-test data is collected, a chatbot-supported application will be installed on the caregivers in the experimental group. In order for them to participate in the sessions and complete the trainings in the determined plan flow, caregivers will be called by phone and reminders will be made and checked. The sessions are expected to end in 4 weeks (8 sessions) (Gabrielli et al., 2021).A participant will be scheduled to finish the application within a maximum of 4 weeks. No intervention will be applied to the control group, they will be followed up within the scope of the routine follow-up and treatment protocol of the clinic. The chatbot-supported application, which will be prepared for stroke patient care providers, has been prepared in line with the literature using the COM-B model according to the needs of caregivers. The prepared training content was sent to the experts and the final shape was given by taking the opinions of the experts
- Conditions
- Chatbot, Anxiety, Depression, Stress, Caregivers
- Being tested
- Assigned Interventions
- Keywords
- stress, Chatbot, paralysis, Caring giver, Nursing Education, Home Care
- Medical subject headings
- Anxiety Disorders, Depression, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned InterventionsOther
Assigned Interventions
| Study group | Role | What they receive |
|---|---|---|
| 1 week : What is Stroke, Taking Care of the Individual with Physical Needs-1 | Experimental | Session 1 What is Stroke, The Importance of Post-Stroke Rehabilitation, Obtaining accurate health information, Contacting the Health Team, Difficult caregiving behaviors Support mechanisms in stroke patient care Receives: Other: Assigned Interventions |
| Week 1: What is a Stroke, Caring for Someone with Physical Needs-2 | Experimental | Session 2 Personal Care, Prevent pressure sores Position and handling techniques Pain In-bed exercises Self-care Nutrition Sleep Speech \& Communication Medication Management Emotional and Cognitive Changes in the Stroke Individual Receives: Other: Assigned Interventions |
| Week 2: Stress of Care, Becoming resistant to stress Coping with stress-1 | Experimental | Session 1 Caregiving role barriers and facilitators Positive Aspects of Caregiving Care Stress and Its Causes, Reaction to Stress Maintaining emotional balance in the caregiving process Receives: Other: Assigned Interventions |
| Week 2: Stress of Care, Becoming resistant to stress Coping with stress-2 | Experimental | Self-knowledge and motivation Maintenance and Time Management Controlling the Body in the Caregiving Process Breathing and relaxation Receives: Other: Assigned Interventions |
| Week 3: Supporting oneself in the caregiving process and becoming resistant to stress-1 | Experimental | Session 1:
Personal space and comfort in the care process Taking time for yourself Unreasonable beliefs and mental regulation technique Tackling anxieties Receives: Other: Assigned Interventions |
| Week 3: Supporting oneself in the caregiving process and becoming resistant to stress-2 | Experimental | The importance of nutrition The importance of physical activity Regulation of sleep Receives: Other: Assigned Interventions |
| 4 week: Control of emotions and spirituality in the process of care-1 | Experimental | Anger management Unleashing emotions and social relationships Use of humor Receives: Other: Assigned Interventions |
| 4 week: Control of emotions and spirituality in the process of care-2 | Experimental | Communication and Empathy Spirituality and religious coping Pray Be happy Receives: Other: Assigned Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
İntroductory form
Consists of questions such as age, gender, marital status, educational status, family type, social security, occupation, having any systemic disease, duration of living with the individual care, and the status of receiving home care services.
Measured: [Time Frame: up to 1 day]
Secondary outcomes (3)
Burden of Care Scale (BVS)
The burden of care was developed in 1980 by Zarit, Reever, and Bach-Peterson. It is a measurement tool used to evaluate the stress experienced by caregivers of individuals in need of care or the elderly. There are 22 items in the measuring tool. Substances are evaluated in Likert type.
Measured: [Time Frame: up to 5 week ]
Lazarus Coping Skills Scale
The Lazarus Stress Coping Skills Scale is a measurement tool used to evaluate individuals' coping mechanisms with stress. Şahin and Durak (1995) developed the 30-item Stress Coping Styles Scale based on the Ways of Coping Inventory developed by Folkman and Lazarus (1985).
Measured: [Time Frame: up to 5 week ]
Depression-Anxiety-Stress (DAS-21) Scale
DASS-21 was created by Lovibond and Lovibond by abbreviation of DAS-42 (Lovibond \& Lovibond, 1995; Lovibond, 1995). The psychometric properties of the Turkish version of the "Depression, Anxiety, Stress-21" (DAS-21) scale in the normal and clinical sample were made by Sarıçam (Sarıçam, 2018).
Measured: [Time Frame: up to 5 week ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start10 Aug 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChatbotStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Yılmaz Bayrakçeken, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544421
- Sponsor's protocol ID
- esrabayrakceken1
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chatbot-Assisted Nursing Education on Perceived Care Burden and Caregiver Stress
- ClinicalTrials.gov ID
- NCT06544421
- Acronym / sponsor ID
- esrabayrakceken1
- Conditions
- Chatbot, Anxiety, Depression, Stress, Caregivers
- Keywords
- stress, Chatbot, paralysis, Caring giver, Nursing Education, Home Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 9 Aug 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.
Caregivers play a key role in the provision of day-to-day care and the coordination of care services. Caregivers of stroke patients use dysfunctional coping strategies to cope with the stressors and burden of care they encounter during this long caregiving process. In this study, it will be tried to improve the stress coping skills of caregivers by using an application with chatbot support based on the COM-B model.In the study, introductory information form, stress coping styles scale, depression, anxiety, stress (DASS 21) and burden of care measurement tool will be used. The study will be conducted in a randomized controlled manner. Chatbot will be applied to the experimental group and the control group will be exposed to routine practice. The study group will consist of individuals who care for those who are discharged home from Atatürk University stroke center. Experiments and controls will be accessed by searching the hospital records. The fact that nursing education is given through a chatbot and that the chatbot is designed according to a stress training model (behavior change wheel) reflects the originality of the study. With this study, caregivers are expected to be able to manage stress effectively by teaching them how to cope with stress.
Detailed description
gree relatives who care for the patients who receive 3-5 points from the Modified Rankin Scale will be discharged from the stroke center of the Neurology Clinic of Atatürk University Health Research and Application Center located in the city center of Erzurum.With the expectation of a 50 percent reduction in the rate of stressed patients in the intervention group and a 10 percent decrease in the control group, it was decided to include 31 people in each group with 90 percent power and 5 percent type 1 error. The sample calculation was calculated using the open epi version 3.01 web interface.It is expected that the implementation and reporting of the research will take 2 years. Year 1 Preparation of chatbot and determination of experimental controls. Implementation of training. Collection of results and writing of the report in 1 year.
The caregivers included in the experimental group will be told about the study and their written consent will be obtained. Individuals in the experimental group will be asked to apply the data collection forms prepared before the use of the application is explained. After the pre-test data is collected, a chatbot-supported application will be installed on the caregivers in the experimental group. In order for them to participate in the sessions and complete the trainings in the determined plan flow, caregivers will be called by phone and reminders will be made and checked. The sessions are expected to end in 4 weeks (8 sessions) (Gabrielli et al., 2021).A participant will be scheduled to finish the application within a maximum of 4 weeks. No intervention will be applied to the control group, they will be followed up within the scope of the routine follow-up and treatment protocol of the clinic. The chatbot-supported application, which will be prepared for stroke patient care providers, has been prepared in line with the literature using the COM-B model according to the needs of caregivers. The prepared training content was sent to the experts and the final shape was given by taking the opinions of the experts
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 week : What is Stroke, Taking Care of the Individual with Physical Needs-1 | Experimental | Other: Assigned InterventionsSession 1 What is Stroke, The Importance of Post-Stroke Rehabilitation, Obtaining accurate health information, Contacting the Health Team, Difficult caregiving behaviors Support mechanisms in stroke patient care |
| Week 1: What is a Stroke, Caring for Someone with Physical Needs-2 | Experimental | Other: Assigned InterventionsSession 2 Personal Care, Prevent pressure sores Position and handling techniques Pain In-bed exercises Self-care Nutrition Sleep Speech \& Communication Medication Management Emotional and Cognitive Changes in the Stroke Individual |
| Week 2: Stress of Care, Becoming resistant to stress Coping with stress-1 | Experimental | Other: Assigned InterventionsSession 1 Caregiving role barriers and facilitators Positive Aspects of Caregiving Care Stress and Its Causes, Reaction to Stress Maintaining emotional balance in the caregiving process |
| Week 2: Stress of Care, Becoming resistant to stress Coping with stress-2 | Experimental | Other: Assigned InterventionsSelf-knowledge and motivation Maintenance and Time Management Controlling the Body in the Caregiving Process Breathing and relaxation |
| Week 3: Supporting oneself in the caregiving process and becoming resistant to stress-1 | Experimental | Other: Assigned InterventionsSession 1: Personal space and comfort in the care process Taking time for yourself Unreasonable beliefs and mental regulation technique Tackling anxieties |
| Week 3: Supporting oneself in the caregiving process and becoming resistant to stress-2 | Experimental | Other: Assigned InterventionsThe importance of nutrition The importance of physical activity Regulation of sleep |
| 4 week: Control of emotions and spirituality in the process of care-1 | Experimental | Other: Assigned InterventionsAnger management Unleashing emotions and social relationships Use of humor |
| 4 week: Control of emotions and spirituality in the process of care-2 | Experimental | Other: Assigned InterventionsCommunication and Empathy Spirituality and religious coping Pray Be happy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- To be at least a primary school graduate
- Caregivers have the cognitive capacity to use chatbots (The chatbot application will be installed on the caregiver's android phone and the status of using it will be evaluated)
- Willingness to participate in the study
- To be open to communication and cooperation
- Having a phone with Android operating system
Key exclusion criteria (2 listed)
- Having received any psychiatric diagnosis.
- Taking antipsychotic medication
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 |
|---|---|---|
| Assigned InterventionsAssigned Interventions | Other | 1 week : What is Stroke, Taking Care of the Individual with Physical Needs-1, 4 week: Control of emotions and spirituality in the process of care-1, 4 week: Control of emotions and spirituality in the process of care-2, Week 1: What is a Stroke, Caring for Someone with Physical Needs-2, Week 2: Stress of Care, Becoming resistant to stress Coping with stress-1, Week 2: Stress of Care, Becoming resistant to stress Coping with stress-2, Week 3: Supporting oneself in the caregiving process and becoming resistant to stress-1, Week 3: Supporting oneself in the caregiving process and becoming resistant to stress-2 |
Primary outcome
İntroductory form
Time frame: [Time Frame: up to 1 day]
Consists of questions such as age, gender, marital status, educational status, family type, social security, occupation, having any systemic disease, duration of living with the individual care, and the status of receiving home care services.
3 secondary outcomes
Burden of Care Scale (BVS)
Time frame: [Time Frame: up to 5 week ]
Lazarus Coping Skills Scale
Time frame: [Time Frame: up to 5 week ]
Depression-Anxiety-Stress (DAS-21) Scale
Time frame: [Time Frame: up to 5 week ]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned Interventions in people with Chatbot and Anxiety, run by Ataturk University.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esra Yılmaz Bayrakçeken (05413112925, esrabayrakceken@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
İntroductory form (time frame: [Time Frame: up to 1 day]). 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 9 Aug 2024.