Determining the effect of tele-nursing education on the incidence and extent of post-discharge pressure ulcer in stroke patients
Design
A randomized trial using color cards, with two parallel intervention (n=30) and control (n=30) groups, not blinded
Settings and conduct
This study will conducted in the post-discharge phase of stroke patients admitted to Ghaem Hospital in Mashhad. Eligible patients are randomly divided into two groups via tele-training using (bale) messengers and routine practice. Finally, the incidence and extent of pressure ulcer will be compared between two groups.
Participants/Inclusion and exclusion criteria
Inclusion: Braden Scale for pressure ulcer less than 14. Age between 45 to 75 years old. Speak in Farsi. BMI between 13-32 kg/m2. Have reading and writing literacy. Access to mobile phone with internet (patient or his relatives).
Exclusion: Symptoms of pressure ulcer or skin disorders at the beginning of the study. Speech and/or hearing problems.
Intervention groups
Intervention group: At discharge, an educational session will be held for the patient or his primary caregiver. After registering an address and phone number, the patient or the primary caregiver will join the channel and group of "Bale" Messenger. Educational contents in the form photos, videos, text, audio files, and more are offered to them to prevent pressure ulcer. At discharge of control groups, an educational session will be held and educational pamphlets are given them as routine.
Main outcome variables
Incidence and the extent of pressure ulcer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190824044595N1
Registration date:2020-02-26, 1398/12/07
Registration timing:registered_while_recruiting
Last update:2020-02-26, 1398/12/07
Update count:0
Registration date
2020-02-26, 1398/12/07
Registrant information
Name
Fatemeh Fashaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
fashaeif951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tele-nursing education on the incidence and extent of post-discharge pressure ulcer in stroke patients
Public title
The effect of tele-nursing education on the incidence of pressure ulcer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has no symptoms of pressure ulcer or skin disorders at the beginning of the study.
Braden Scale less than 14
Age between 45 to 75 years
Residency in Mashhad
Willingness to participate in the study
Speak Farsi
BMI between 13-32 kg/m2
Have reading and writing ability
Mobile phone with internet access (patient or his attendance)
Exclusion criteria:
Has movement restriction (e.g. hemiplegia or paraplegia or quadriplegia)
Has speech and/or hearing problem
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using color cards. In this way, the red (intervention) and green (control) cards will be randomly arranged in an envelope. Then, with the gradual entry of patients into the study, one of the cards that determines group allocation, respectively, will be awarded.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery ,Ibn Sina Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2019-11-26, 1398/09/05
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.072
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Incidence of pressure ulcer
Timepoint
At the beginning and one month after the intervention
Method of measurement
Pressure ulcer grading scale EPUAP/NPUAP
2
Description
Extent of pressure ulcer
Timepoint
At the beginning and one month after the intervention
Method of measurement
Push scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: At the discharge, a training session will be held at the hospital for the patient or his primary caregiver. Then all the necessary educational contents about preventing bed ulcers, susceptible areas, diet and skin care ... in the different formats as photos, videos, text and audio are presented via the channel created in the (Bale) messenger (according to the Ministry of Health protocol). Communicating with the patient or their primary caregiver is performed through this messenger during 24 hours a day, as personal message or group message.
Category
Prevention
2
Description
Control group: At discharge, an educational session will be held for the patient or his primary caregiver. Then they are given educational pamphlets as routine.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Fatemeh Fashaei
Street address
Ghaem Hospital, Ali Shariati Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Fax
+98 51 3845 3239
Email
fashaeif951@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
Froutanr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Fashaei
Position
MsC student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
fashaeif951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Froutan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina Street, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
Froutanr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Fashaei
Position
MsC of Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina Street, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
fashaeif951@mums.ac.ir
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