Effect of Post-stroke Discharge Training

NCT04648098 | Completed DMC

• 1 other identifier: interventional
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Caregiver Burnout

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Experimental: Intervention group

EXPERIMENTAL

Discharge training and telephone counseling

Other: Discharge training and telephone counseling

No Intervention: Control Group

NO INTERVENTION

Routine care

Interventions

Discharge training and telephone counseling OTHER

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.

Experimental: Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Rankin Scale score of 4 above (for patients)
• Having problem in terms of hearing and understanding (for caregivers)

Sponsors & Collaborators

• Kırklareli University: lead
• Trakya University: collaborator

Study Sites (1)

Kırklareli University

Kırklareli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Caregiver Burden

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Özgül EROL

  Trakya University

  STUDY DIRECTOR

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: Principal Investigator

Model Details: Interventional (Clinical Trial)

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 1, 2020
• Study Start: March 4, 2017
• Primary Completion: April 8, 2018
• Study Completion: April 29, 2018
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)