- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06544421
The Impact of Chatbot-Assisted Nursing Education on Perceived Burden of Care and Caregiver Stress
The Effect of Chatbot-Assisted Nursing Education on Perceived Care Burden and Caregiver Stress
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Esra Yılmaz Bayrakçeken
- Phone Number: 05413112925
- Email: esrabayrakceken@atauni.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having received any psychiatric diagnosis.
- Taking antipsychotic medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1 week : What is Stroke, Taking Care of the Individual with Physical Needs-1
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
|
Assigned Interventions
|
|
Experimental: Week 1: What is a Stroke, Caring for Someone with Physical Needs-2
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
|
Assigned Interventions
|
|
Experimental: Week 2: Stress of Care, Becoming resistant to stress Coping with stress-1
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
|
Assigned Interventions
|
|
Experimental: Week 2: Stress of Care, Becoming resistant to stress Coping with stress-2
Self-knowledge and motivation Maintenance and Time Management Controlling the Body in the Caregiving Process Breathing and relaxation
|
Assigned Interventions
|
|
Experimental: Week 3: Supporting oneself in the caregiving process and becoming resistant to stress-1
Session 1: Personal space and comfort in the care process Taking time for yourself Unreasonable beliefs and mental regulation technique Tackling anxieties |
Assigned Interventions
|
|
Experimental: Week 3: Supporting oneself in the caregiving process and becoming resistant to stress-2
The importance of nutrition The importance of physical activity Regulation of sleep
|
Assigned Interventions
|
|
Experimental: 4 week: Control of emotions and spirituality in the process of care-1
Anger management Unleashing emotions and social relationships Use of humor
|
Assigned Interventions
|
|
Experimental: 4 week: Control of emotions and spirituality in the process of care-2
Communication and Empathy Spirituality and religious coping Pray Be happy
|
Assigned Interventions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
[Time Frame: up to 1 day]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Burden of Care Scale (BVS)
Time Frame: [Time Frame: up to 5 week ]
|
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.
|
[Time Frame: up to 5 week ]
|
|
Lazarus Coping Skills Scale
Time Frame: [Time Frame: up to 5 week ]
|
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).
|
[Time Frame: up to 5 week ]
|
|
Depression-Anxiety-Stress (DAS-21) Scale
Time Frame: [Time Frame: up to 5 week ]
|
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).
|
[Time Frame: up to 5 week ]
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- esrabayrakceken1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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