Effect of Post-stroke Discharge Training
Primary Purpose
Stroke, Caregiver Burnout
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Discharge training and telephone counseling
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- the age of 18 and over (for patients and caregivers)
- having undergone a hemorrhagic or ischemic stroke (for patients)
- being literate (for caregivers)
- being primarily responsible for the care of the stroke patient during the hospital stay and at home after discharge (for caregivers)
- using a mobile or home phone (for caregivers)
- being open to communication and collaboration (for caregivers)
Exclusion Criteria:
- Rankin Scale score of 4 above (for patients)
- Having problem in terms of hearing and understanding (for caregivers)
Sites / Locations
- Kırklareli University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental: Intervention group
No Intervention: Control Group
Arm Description
Discharge training and telephone counseling
Routine care
Outcomes
Primary Outcome Measures
Caregiver Burden Scale
Caregiver Burden Scale, developed by Zarit et al. (1980), was used to evaluate the care burden of patient relatives. There are 22 expressions in the scale that determine the effect of caregiving on the individual's life. The score obtained from the five-point Likert scale is minimum 0 and maximum 88.A high score on the scale indicates that the problem experienced by the caregiver is high.
The Barthel Index
The Barthel Index to developed by Mahoney and Barthel in 1965 to evaluate physical independence in daily life activities. Index consists of 10 items that include daily life activities and is used to evaluate the level of functional independence. Items in the scale are graded between 0 and 15 points in 5 increments according to the question. The score ranges from 0 to 100 (0-20 points fully dependent, 21-61 points highly dependent, 62-90 points moderately dependent, 91-99 points slightly dependent, 100 points fully independent).
Modified Rankin Scale
Modified Rankin Scale evaluating the functional limitation and degree of addiction occurring in the patient after stroke was evaluated in seven categories (0: No symptoms, 1: No obvious deficits, 2: Mild deficits, 3: Moderate deficits, 4: Severe deficits, 5: Very severe deficit and 6: Death).
Secondary Outcome Measures
Full Information
NCT ID
NCT04648098
First Posted
November 18, 2020
Last Updated
March 8, 2023
Sponsor
Kırklareli University
Collaborators
Trakya University
1. Study Identification
Unique Protocol Identification Number
NCT04648098
Brief Title
Effect of Post-stroke Discharge Training
Official Title
The Effect of Post-stroke Discharge Training and Telephone Counseling Service on Patients' Functional Status and Caregiver Burden: A Randomised Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 4, 2017 (Actual)
Primary Completion Date
April 8, 2018 (Actual)
Study Completion Date
April 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kırklareli University
Collaborators
Trakya University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to determine the effect of post-stroke discharge training and telephone counseling service on patients' functional status and caregiver burden. The study was conducted with 69 stroke patients (34 in the intervention group and 35 in the control group) and their caregivers. In the study, data were collected before discharge and three months after discharge. Discharge training and telephone counseling (one week after discharge and once a month for three months) were given to the caregivers of the patients in the intervention group.
Detailed Description
This study, which was planned as a randomised controlled study, was conducted university hospital neurology clinic in Turkey. A total of 80 participants who met the inclusion criteria were randomised to either the intervention and control groups.
In this study, Patient Information Form, Modified Rankin Scale and Barthel Index were used to collect data about patients, while Caregiver Information Form and Caregiver Burden Scale were used to collect data about caregivers Pre-tests were applied to patients and caregivers in the intervention and control groups before discharge. After the pre-tests were applied to the caregivers in the intervention group, discharge training was given.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Caregiver Burnout
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional (Clinical Trial)
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Intervention group
Arm Type
Experimental
Arm Description
Discharge training and telephone counseling
Arm Title
No Intervention: Control Group
Arm Type
No Intervention
Arm Description
Routine care
Intervention Type
Other
Intervention Name(s)
Discharge training and telephone counseling
Intervention Description
The discharge training was given by using different teaching methods in the form of verbal expression, demonstration, and question and answer. The care guide prepared by the researchers in line with the literature was used as a training material for stroke patients and their caregivers.The training varied according to the learning level of individuals but took an average of 40-60 minutes.
Consultation service was given to the caregivers one week after discharge and once a month for three months by telephone call.
Primary Outcome Measure Information:
Title
Caregiver Burden Scale
Description
Caregiver Burden Scale, developed by Zarit et al. (1980), was used to evaluate the care burden of patient relatives. There are 22 expressions in the scale that determine the effect of caregiving on the individual's life. The score obtained from the five-point Likert scale is minimum 0 and maximum 88.A high score on the scale indicates that the problem experienced by the caregiver is high.
Time Frame
Change from baseline score at the end of the third month
Title
The Barthel Index
Description
The Barthel Index to developed by Mahoney and Barthel in 1965 to evaluate physical independence in daily life activities. Index consists of 10 items that include daily life activities and is used to evaluate the level of functional independence. Items in the scale are graded between 0 and 15 points in 5 increments according to the question. The score ranges from 0 to 100 (0-20 points fully dependent, 21-61 points highly dependent, 62-90 points moderately dependent, 91-99 points slightly dependent, 100 points fully independent).
Time Frame
Change from baseline score at the end of the third month
Title
Modified Rankin Scale
Description
Modified Rankin Scale evaluating the functional limitation and degree of addiction occurring in the patient after stroke was evaluated in seven categories (0: No symptoms, 1: No obvious deficits, 2: Mild deficits, 3: Moderate deficits, 4: Severe deficits, 5: Very severe deficit and 6: Death).
Time Frame
Change from baseline score at the end of the third month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the age of 18 and over (for patients and caregivers)
having undergone a hemorrhagic or ischemic stroke (for patients)
being literate (for caregivers)
being primarily responsible for the care of the stroke patient during the hospital stay and at home after discharge (for caregivers)
using a mobile or home phone (for caregivers)
being open to communication and collaboration (for caregivers)
Exclusion Criteria:
Rankin Scale score of 4 above (for patients)
Having problem in terms of hearing and understanding (for caregivers)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özgül EROL
Organizational Affiliation
Trakya University
Official's Role
Study Director
Facility Information:
Facility Name
Kırklareli University
City
Kırklareli
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Post-stroke Discharge Training
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