determin the effect of self-care education with smartphone application on complications of stemcell transplantation in leukemic patients
Design
Randomized clinical trial; with control group, parallel groups, without blinding
Settings and conduct
The statistical population of this study is leukemia patients undergoing stem cell transplantation.The research place is the transplant parts of Dr. Shariati Hospital of Tehran. when patient is admitted to the transplant part after obtaining informed consent, the self-care education application and how to use it, is given to patient. two weeks, one, two and three months after the intervention, the relevant questionnaires will be completed with patient cooperation.
Participants/Inclusion and exclusion criteria
"The inclusion criteria" at least reading and writing literacy, ages 15 to 60, having an android mobile phone by the patient or his carers (family),Patients with leukemia and candidates for stem cell transplantation، the absence of identified psychological disorders. "Exclusion criteria" patient does not participate as a research sample in Other research at the same time .
The client is not from the medical staff and the client or his / her family has no history of bone marrow transplantation, and If the patient does not want to use the application will be excluded from the study.
Intervention groups
"Control group" receive routine care and training includes a pre-transplant group training session that is conducted as a lecture at the transplantation center. In "Intervention Group" in addition that a self-care education app developed by the researcher and approved by four specialists is installed on the patient's cellphone. The duration of the intervention is before transplant chemotherapy up to three months after the intervention.
Main outcome variables
nausea and vomiting ،
Mucositis،
Infection ،
anxiety and depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100725004443N28
Registration date:2020-01-11, 1398/10/21
Registration timing:registered_while_recruiting
Last update:2020-01-11, 1398/10/21
Update count:0
Registration date
2020-01-11, 1398/10/21
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education with smartphone application on complications of stemcell transplantation in leukemic patients
Public title
The effect of self-care education with smartphone application on complications of stem cell transplantation
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least reading and writing skills
Age between 15 and 60 years
Having an Android mobile phone by a patient or his family
Lack of psychological disorders detected
Patients with leukemia candidates for stem cell transplantation
Exclusion criteria:
The client is not simultaneously involved in another research as a research sample
The client does not want to use the application
If the client is from the medical staff
The client or his/her family has a history of bone marrow transplantation
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be selected by continuous sampling and the patients will be placed in two groups of control and intervention by Block Balanced Randomization (BBR). By using the free web site http://www.randomization.com/, the assignment sequence will take place..
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 Tehran University of Medical Sciences
Street address
Office building of Tehran University of medical Sciences, Keshavarz St, Tehran.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-06-19, 1398/03/29
Ethics committee reference number
IR.TUMS.FNM.REC.1398.039
Health conditions studied
1
Description of health condition studied
complications of stemcell transplantation in leukemic patients
ICD-10 code
C95.9
ICD-10 code description
Leukemia, unspecified
Primary outcomes
1
Description
anxiety and depression(A score above 11 based on the Hospital Anxiety and Depression Scale)
Timepoint
Two weeks, one and three months after the intervention
Method of measurement
Hospital Anxiety and Depression Scale
2
Description
Nausea(Mild or Moderate or Severe by Scale)
Timepoint
Two weeks, one and three months after the intervention
Method of measurement
Visual analogue scale (VAS)
3
Description
vomiting(Mild or Moderate or Severe by Scale)
Timepoint
Two weeks, one and three months after the intervention
Method of measurement
khavar oncology scale
4
Description
Mucositis(Grade 0 to Grade 4 by scale)
Timepoint
Two weeks, one and three months after the intervention
Method of measurement
Form of diagnosis and severity of mucositis
5
Description
infection(yes or no based on scale)
Timepoint
One and three months after the intervention
Method of measurement
Clinical and laboratory signs and symptoms of infection in patients undergoing stem cell transplantation
6
Description
Readmission
Timepoint
One and three months after the intervention
Method of measurement
Readmission Rate Form
Secondary outcomes
empty
Intervention groups
1
Description
Control group: For patients in the control group, routine care and routine training includes a pre-transplant group training session that is conducted through the lecture center at the transplantation center.
Category
Other
2
Description
Intervention group: In Intervention group, the researcher train the self-care education program with smart phone application in addition to the routine training of the transplantation center. this application was made by the researcher and confirmed by four experts. we give the smartphone application to the patient or his caregiver (in patients who need care) and train them how to use the application and practice with them and also their possible questions are answered. if there is a problem or the question to answer them the researcher's mobile phone number is given to them. also the patient's phone number will be taken by the researcher and will be contacted by the investigator weekly at least 10 minutes in the morning or evening, in order to encourage the use of the educational application and respond to the patient's likely questions.This smartphone application includes: leukemia, treatment methods, familiarity with bone marrow transplantation and its stages of action, possible complications and self-care methods for these patients, training in appropriate post-transplant nutrition, training on how to control infection , Cleaning, bathing, hand washing, oral hygiene, the way and rate of meeting and communication with others and observing its principles, possible complications of the disease and methods for preventing complications and early diagnosis, relief of symptoms, control and prevention methods Nausea and vomiting, oral ulcers and mucositis, and anxiety control methods.this smartphone application are approved by four members of the faculty and transplantation department. During the intervention, which starts from the beginning of pre-transplant chemotherapy as a linkage regimen and continue for up to three months after the transplantation, the questionnaire for transplantation complication will be completed Selectively in both control and intervention groups after two weeks, one and three months.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital in Tehran
Full name of responsible person
Dr Masoumeh Zakeri Moghaddam
Street address
Shariati Hospital Research & Treatment Center, Three Way Jalal Al Ahmad, North Kargar St, Tehran.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
6th floor of Research and Technology Department, Central Organization of the University, Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Fax
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Jalal Rezaei
Position
Master Student of Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat St. Tohid Sq Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Fax
+98 21 6105 4000
Email
jalalrezaei1989@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Masoumeh Zakeri Moghaddam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Fax
+98 21 6105 4000
Email
mzakerimo@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Jalal Rezaei
Position
Master Student of Critical Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat St. Tohid Sq Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Fax
+98 21 6105 4000
Email
jalalrezaei1989@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available