NCT06544421

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 6, 2024

Last Update Submit

August 6, 2024

Conditions

Keywords

stressChatbotparalysisCaring giverNursing EducationHome Care

Outcome Measures

Primary Outcomes (1)

  • 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.

    [Time Frame: up to 1 day]

Secondary Outcomes (3)

  • Burden of Care Scale (BVS)

    [Time Frame: up to 5 week ]

  • Lazarus Coping Skills Scale

    [Time Frame: up to 5 week ]

  • Depression-Anxiety-Stress (DAS-21) Scale

    [Time Frame: up to 5 week ]

Study Arms (8)

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

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

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

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

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

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

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

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

Other: Assigned Interventions

Interventions

Assigned Interventions

1 week : What is Stroke, Taking Care of the Individual with Physical Needs-14 week: Control of emotions and spirituality in the process of care-14 week: Control of emotions and spirituality in the process of care-2Week 1: What is a Stroke, Caring for Someone with Physical Needs-2Week 2: Stress of Care, Becoming resistant to stress Coping with stress-1Week 2: Stress of Care, Becoming resistant to stress Coping with stress-2Week 3: Supporting oneself in the caregiving process and becoming resistant to stress-1Week 3: Supporting oneself in the caregiving process and becoming resistant to stress-2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Having received any psychiatric diagnosis.
  • Taking antipsychotic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersDepressionParalysis

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Esra Yılmaz Bayrakçeken

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Esra Yılmaz Bayrakçeken

Study Record Dates

First Submitted

August 6, 2024

First Posted

August 9, 2024

Study Start

August 10, 2024

Primary Completion

November 30, 2024

Study Completion

July 31, 2025

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share