We aim to provide post liver transplant (LTx) educational material following a systematic mixed-method triphasic process, including: 1) inductive thematic content analysis on available international resources, 2) complementing provided material in step 1 by utilizing patients’ experiences and 3) establishing final content using expert consensus approach. Designed material will be evaluated as a mobile-based multimedia intervention among LTx recipients. The evaluation study will be performed as a single-center non-blinded 2-armed randomized control trial on all patients who underwent LTx procedure at the time of study in Montaserieh Transplant Center, northeast Iran. Patients in intervention and control groups (70%-30%) will be assigned randomly but are matched based on age, gender and education level. While baseline literacy has been considered as major inclusion criterion, once a patient refuse to receive the intervention application he/she will be excluded. Patients’ procedural knowledge and level of activation will be assessed as primary and secondary outcomes after a 2-month perception period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030626934N1
Registration date:2016-05-05, 1395/02/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-05, 1395/02/16
Registrant information
Name
Fariba Tohidinezhad
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2429
Email address
tohidinf921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-04-23, 1395/02/04
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design of a Post Liver Transplant Care Model and Assessing its Effect on
Patients’ Procedural Knowledge and self-reported Activation
Public title
Effect of IT (Information Technology) interventions on liver transplant recipients’ knowledge
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Patients who underwent liver transplantation procedure (partial or whole, deceased donor or living donor); Not illiterate
Exclusion Criteria: Unwillingness of recipient to cooperate
Age
From 11 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
61
Randomization (investigator's opinion)
Randomized
Randomization description
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
Faculty of Medicine Ethical Committee
Street address
Mashhad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
IR.MUMS.fm.REC.1394.630
Health conditions studied
1
Description of health condition studied
Liver transplantation
ICD-10 code
Z94.4
ICD-10 code description
Liver transplant status
Primary outcomes
1
Description
Post-transplant Procedural Knowledge Level
Timepoint
2 months
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Patient Activation
Timepoint
2 months
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group will use a mobile-based application containing post-transplant care points and a bi-directional clinical communication path during 2 months perception period.
Category
Prevention
2
Description
Control group continue their daily routine activities without using the designed education-based intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Montaserieh Organ Transplant Center
Full name of responsible person
Monir Mirzadeh Noodeh
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fahimeh Ebrahimzadeh
Street address
Mashhad University of Medical Sciences
City
Mashhad
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Student Research Committee, Department of Medical Informatics, School of Medicine, Mashhad Universit
Full name of responsible person
Fariba Tohidinezhad
Position
MSc Student
Other areas of specialty/work
Street address
Building 10, Moezi Street, Golestan BLVD
City
Shiraz
Postal code
Phone
+98 71 3229 2792
Fax
Email
Tohidinf921@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmaceutical Research Center, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad,
Full name of responsible person
Saeid Eslami
Position
Assistant Professor of Medical Informatics
Other areas of specialty/work
Street address
Faculty of Medicine
City
Mashhad
Postal code
Phone
+98 51 3882 7048
Fax
Email
EslamiS@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Student Research Committee, Department of Medical Informatics, School of Medicine, Mashhad Universit
Full name of responsible person
Fariba Tohidinezhad
Position
MSc Student
Other areas of specialty/work
Street address
Building 10, Moezi Street, Golestan BLVD
City
Shiraz
Postal code
Phone
+98 71 3229 2792
Fax
Email
Tohidinf921@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)