Protocol summary

Study aim
Identifying the effect of liaison nurse role on the incidence of complications after a stroke
Design
Patients is selected according to Inclusion and exclusion criteria, and randomly divided into two groups. The questionnaire consisting of two parts. The first part was demographic information and severity of stroke. The second part was a checklist of pneumonia, urinary tract infection (UTI), fall, constipation, pressure sore and severity of it, in two weeks and two months after nursing intervention in two groups.
Settings and conduct
In the intervention group, the nurse evaluates the patient on the first day of admission, identifies the needs, and provides a care program according to the priorities of each patient. The patient is visited at home by the nurse if necessary. Patients in both groups are evaluated for two weeks and two months.
Participants/Inclusion and exclusion criteria
Patients admitted for diagnosis of stroke to neurology and ICU department Inclusive criteria: 16-25 based on stroke criteria; age 45-85 Exclusive criteria: pressure sore and constipation and immobility before the stroke
Intervention groups
Care and education in the intervention group with emphasis on preventing side effects of disease. based on the nursing guidelines. Patients in control group receives routine nursing cares.
Main outcome variables
The incidence of pneumonia, UTI, fall, constipation, pressure sore, and severity of it, in two weeks and two months after nursing intervention in two groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170605034330N3
Registration date: 2018-04-04, 1397/01/15
Registration timing: retrospective

Last update: 2018-04-04, 1397/01/15
Update count: 0
Registration date
2018-04-04, 1397/01/15
Registrant information
Name
Sedighe Ebrahimi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1751
Email address
sedigheebrahimi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the Effect of liaison Nurse Role on the Incidence and Severity Rate of Complication After a Strock in Hospitalized Patientse
Public title
Examining the Effect of liaison Nurse Role on the Incidence and Severity Rate of Complication After a strock in Hospitalized Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having a score16-25 based on the criteria for a stroke (NIHSS) age 45-85
Exclusion criteria:
Having bed sore before stroke Having constipation before stroke Having immobility before stroke
Age
From 45 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Random Allocation With Using Random Numbers Table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Does Not Have

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
The central building of Shahid Sadoughi University of Medical Sciences; Bahonar Sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2017-05-23, 1396/03/02
Ethics committee reference number
IR.SSU.REC.1396.43.

Health conditions studied

1

Description of health condition studied
Stroke
ICD-10 code
I63.0
ICD-10 code description
Cerebral infarction due to thrombosis of precerebral arteries

Primary outcomes

1

Description
Incidence of Pneumonia
Timepoint
2 weeks, 2 months after intervention
Method of measurement
Diagnos of doktor (Acceptable of WHo); condition of pataint, chest x_ray, sputum culture

2

Description
Incidence of urinary tract infection
Timepoint
2weeks, 2months post of intervention of liasion nurse
Method of measurement
Diagnosis of doktor (accetable ofWHO);condition of pt, fever, urin culture, lukositos

3

Description
Incidence of bed sore
Timepoint
2 weeks and 2 months post of intervention by liaion nurse
Method of measurement
physical exam of skin by liason nurse and diagnosis by NUPAP

4

Description
Incidence of falling down
Timepoint
2weeks and 2months post of intervention of liasion nurse
Method of measurement
Self report by patiant and family

5

Description
Incidence of constipation
Timepoint
2 weeks and 2 months post of intervention of liasion nurse
Method of measurement
Scale rome3

6

Description
Severity of bed sore
Timepoint
2 weeks and 2 months post of intervention by liaion nurse
Method of measurement
Severity by scale of poosh tool

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients are assessed on the first day of hospitalization by the nurse and prioritized on the basis of the probability of complications of pneumonia, urinary tract infection, pressure sore, fall, and constipation. Care planning is done by the nurse. Training to the patient's family on the patient's bedside is done within 2 days of admission (the first day of oral education and the second day in practical form). The patient or family of the patient is given a telephone number to communicate with the liaison nurse to resolve potential problems by coordinating the nurse.
Category
Prevention

2

Description
Control group: Patient in the control group receives routine nursing cares.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Asghar Hospital of Shiraz
Full name of responsible person
Sedighe Ebrahimi
Street address
Meshkin Fam Avenu, Ali Asghar Hospital, Shiraz
City
Shiraz
Province
Fars
Postal code
7143918756
Phone
+98 71 3228 8602
Email
sedigheebrahimi@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Dr.َ Amirhooshang Mehrparvar
Street address
Central building of Shahid Sadoughi University of Medical Sciences, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3724 0171
Email
ah.mehrparvar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences, Yazd
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Full name of responsible person
Zohreh Kalani
Position
Member of Scientific Board, Shahid Sadoughi College of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
College of Nursing and Midwifery, Buali St., Timsar Fallahi St., Safaeeye.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Fax
Email
kalani_z@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Zohreh Kalani
Position
Member of Scientific Board of Nursing and Midwifery Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Buali St, Timsar Fallahi St., Safaeeyeh.
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Fax
Email
kalani_z@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Saduoghi University of Medical Sciences, Yazd
Full name of responsible person
Sedighe Ebrahimi
Position
MSc. student of Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Facuilty, Buali St, Timsar Fallahi St., Safaeeyeh
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Fax
Email
ebrahimi.mi222@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
This is a research study conducted within the framework of the dissertation.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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