To determine the effect of self- care with tele nursing approach based on quality of life and satisfaction of patients with upper gastrointestinal bleeding
Design
Clinical trial with control group, double blind, blocked randomization; parallel group design of 98 patients will be followed-up for one month.
Settings and conduct
Target group are patients with upper gastrointestinal bleeding, hospitalized in Mashhad educational hospitals. A self-care application will be designed that its content validity will be measurement by reviewing texts and its functionality will be approved by a computer specialist and application user form, MARS, which has to be fulfilled by the patients. Then the quality of life would be surveyed by (GIQLI)tool and Tele-nursing, by (TISQ) tool, in two phases(at the start and in the end of the study). Patients, analyzers and evaluators will be blinded. Finally, data evaluation and analysis is performed in SPSS.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to participate in the study; diagnosis of gastrointestinal bleeding; age 20-65 years old; not participating in the previous or current self-care education; having literacy and access to a smartphone.
Exclusion criteria: diagnosis of esophageal varices; liver cirrhosis; inflammatory bowel disease; psychological issues; turning to unstable situation; death and the need for surgery during the study.
Intervention groups
Intervention group: perform Self-care education with tele-nursing approach in three areas: group discussion, telephone follow-up (twice a week individually) and daily use of a self-care application. In the control group: routine trainings before discharge and telephone follow-up twice a week by a specialist nurse will be done.
Main outcome variables
Improving quality of life and satisfaction of patients by self-care education with tele-nursing approach to reduce complications.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201231049897N1
Registration date:2021-01-15, 1399/10/26
Registration timing:prospective
Last update:2021-01-15, 1399/10/26
Update count:0
Registration date
2021-01-15, 1399/10/26
Registrant information
Name
Reihaneh Lajevardi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3502 8309
Email address
rlajevardir@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self- care education based on tele-nursing approach on quality of life and satisfaction of patients with upper gastrointestinal bleeding
Public title
The effect of self- care education based on tele-nursing approach on quality of life and satisfaction of patients with upper gastrointestinal bleeding
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Signing informed consent to participate in the study.
suffering from upper gastrointestinal bleeding.
The age of patients should be between 20 to 65 years.
Do not participate in other self-care education programs at the same time.
Having access to a smartphone.
Be literate in using a smartphone.
Exclusion criteria:
If the patient has psychological problems.
If the patient has gastrointestinal bleeding with esophageal varices and liver cirrhosis source.
If the patient has a diagnosis of inflammatory bowel disease.
If the patient becomes unstable during the study or needs surgery.
If the patient dies during the study.
If the patient does not want to continue to cooperate during the study.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be made in blocks in order to keep the sizes of treatment groups similar. According to the sample size population, two groups of 46 people, intervention and control, considering the possibility of reduction during the study, 20 groups with 5 participants in each block will be allocated. Randomization is done in each group with SPSS software. So, the investigator does not interfere in how sequencing participant assigned by block .
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are kept blind in this study, and each participant will only receive full explanation of the educational conditions he or she is going to experience in this study, and is unaware of which group he or she belongs to and each patient will receive his or her trainings individually in a private room.
Healthcare personnel will also be blind about how patients are assigned to the groups, so they will educate the patients all routine pre-discharge trainings in his/her specific ward equally.
The person who performs the final evaluation and also the statistical expert who performs the statistical analysis is blind in this study and finally the researcher will not interfere her personal opinion in the allocation and sequencing of control and intervention groups since this would be done SPSS software .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of medical science university of Mashhad
Street address
4th floor,No.22, 13th Eghbal Lahoori alley, Eghbal Lahoori st, Vakil Abad Blv
City
Mashhad
Province
Razavi Khorasan
Postal code
9178193111
Approval date
2021-01-02, 1399/10/13
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.061
Health conditions studied
1
Description of health condition studied
Upper gastrointestinal bleeding and tele-nursing
ICD-10 code
K29.0
ICD-10 code description
Acute gastritis or erosion with bleeding
Primary outcomes
1
Description
Satisfaction score which is accessed by tele-nursing intervention and satisfaction questionnaire .
Timepoint
Before intervention and 2, 4 weeks after intervention
Method of measurement
Tele-nursing intervention and satisfaction tool to measure satisfaction and The gastrointestinal quality of life index to measure quality of life.
2
Description
Access more than 45 in gastrointestinal quality of life index.
Timepoint
Before intervention and 2, 4 , 6 weeks after intervention
Method of measurement
Gastrointestinal quality of life index to measure quality of life in gastrointestinal patients.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first session: After obtaining informed consent from patients and having the code of ethics from Ethics committee of Medical science university of Mashhad, the researcher will ask patients who are hospitalized in the surgery or emergency department of educational hospitals to fulfill 3 surveys:( the demographic and disease data, tele-nursing satisfaction questionnaire and gastrointestinal quality of life index). After basic introduction researcher emphasizes on making a proper relationship with the patient by active listening, using appropriate sentences to prove professional competence and having up-to-date information ,also gaining trust and encouragement to cooperate with the patient in the care and education process. Then,The intervention will be continued virtually. Session 2: In a face-to-face session the investigator will introduce the user guide of a self-care application, specifies for gastrointestinal bleeding patients, answers their questions about how to install this app on their smartphones also provides a user manual book for them. Interaction channel via an application on smartphone : These sessions will be held virtually after the patient is discharged. The goal of daily use of this application, as an outside resource, is to increase self-care awareness and knowledge of these patients in three aspects: diet, activity and rest. In addition patients would be familiar with their disease classification, how to face with complication of their medications and recurrent signs and symptoms. They could also report their experimental tests like: CBC,weight,etc. Alarms could be set to remind their visit or medication time. ّThe call nurse menu will engage them to report their documents to the investigator. Second way of virtual interaction is planned via telephone call: Each patient would receive 2 calls weekly between 8Am-8Pm during one month follow-up, which will be performed by validated questionnaire and focuses on four main factors in satisfaction of telenursing questionnaire, including: Health information, effective support, decision making, professional competence and self-care education. The duration of each call differs, depends on patients needs. The third way of telenursing approach in this study is establishing group discussions in whatsapp based on source of their bleeding by the aim of sharing similar concerns in similar patients to engage more interaction. Like: Their daily issues about diet,activity and psychological problems and same challenges in medication complications and finally, modeling correct behaviour through patient's need to improve their self-care skills.The duration of each session would be 30-45 minutes twice a week but could be stretched based on group necessities.
Category
Lifestyle
2
Description
Control group: The admitted upper gastrointestinal bleeding patients in emergency and gastrointestinal wards of educational hospitals in Mashhad city would fulfill three questionnaires at the beginning of the study and 2 and 4 weeks after that, which contains: informed consent, demographic data, gastrointestinal quality of life index and tele-nursing intervention and satisfaction questionnaire. This group will benefit from all routine trainings before discharge from hospital and they will receive all educational materials same as intervention group in a form of educational pamphlets.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Reihaneh Lajevardi
Street address
Imam Reza square, Ebn Sina St, Mashhad, Khorasan province
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
support@rpsi.ir
Web page address
2
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Reihaneh Lajevardi
Street address
Before ِDoctor Shariati square, Ahmadabad St, Ghem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9187145785
Phone
+98 51 3849 0000
Email
rlajevardir@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Aghebati
Street address
School of Nursing and Midwifery, Ebne sina Ave, ِdoctora intersection, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Aghebatin@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research and Technology of Mashhad University of Medical Sciences and Health Services
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
Reihaneh Lajevardi
Position
Master degree of nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
School of Nursing and Midwifery, Ebne sina Ave, ِDoctora intersection, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91375345
Phone
+98 51 3859 1511
Email
rlajevardir@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reihaneh Lajevardi
Position
Student
Latest degree
Master
Other areas of specialty/work
Medical surgical nursing
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doctora intersection, Daneshgah St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
lajvardir921@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reihaneh Lajevardi
Position
Student
Latest degree
Master
Other areas of specialty/work
Medical surgical nursing
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doctora intersection, Daneshgah St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9178193111
Phone
+98 51 3502 8309
Fax
Email
rlajevardir@gmail.com
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
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
IPD collected for the primary outcome measure only.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
Datas will not become accessible.
Under which criteria data/document could be used
Datas will not become accessible.
From where data/document is obtainable
Datas will not become accessible.
What processes are involved for a request to access data/document