Effect of Post-stroke Discharge Training

The Effect of Post-stroke Discharge Training and Telephone Counseling Service on Patients' Functional Status and Caregiver Burden: A Randomised Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Caregiver Burnout
• Intervention / Treatment: Other: Discharge training and telephone counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kırklareli, Turkey
    • Kırklareli University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Intervention group; Discharge training and telephone counseling	Other: Discharge training and telephone counseling; 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.
No Intervention: No Intervention: Control Group; Routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline score at the end of the third month
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).	Change from baseline score at the end of the third month
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).	Change from baseline score at the end of the third month

Collaborators and Investigators

• Sponsor: Kırklareli University
• Collaborators: Trakya University
• Investigators: Study Director: Özgül EROL, Trakya University

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2017
• Primary Completion (Actual): April 8, 2018
• Study Completion (Actual): April 29, 2018

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stress, Psychological; Stroke; Caregiver Burden
• Other Study ID Numbers: Interventional (Oncolys BioPharma Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No