Determining the Effect of Participatory Care Pattern Based Intervention on Fatigue Status in Patients with Thalassemia Major
Design
A total of 122 major thalassemic patients undergoing regular treatment are enrolled in a full-scale study, divided into 12 groups based on gender and age.
Settings and conduct
.Intervention on patients with thalassemia major referred to the thalassemic department of Yasouj Shahid Beheshti Hospital, which was entered into the study, is conducted and the classes and all activities are performed in the hall for teaching the Yasuj Shahid Beheshti Hospital.
Participants/Inclusion and exclusion criteria
Diagnosis of thalassemia major approved by the hematologist and treated under regular care.
Intervention groups
In this study, individuals are divided into two groups: intervention and control. To achieve the goals of the educational program, a participatory care model is implemented.This template has 4 steps: 1- Motivation 2- Preparation 3- Engagement and 4- Evaluation. By randomization, the control group is divided into groups of 10 to 11, and the training classes are held according to the participatory care model for them, and the control group does not see any training during this period. At the first intervention session (motivation), the best mechanism for motivating patients to be informed about the status quo and the possible consequences for them is to try to communicate with patients and get their medical history. In the second session (preparation), an educational timetable is provided to them, and here the requirements are also explained to the clients about the nature of the visits (training sessions and follow-up), the duration of each visit and the purpose of the visits.
Main outcome variables
fatigue status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190424043367N1
Registration date:2019-08-11, 1398/05/20
Registration timing:retrospective
Last update:2019-08-11, 1398/05/20
Update count:0
Registration date
2019-08-11, 1398/05/20
Registrant information
Name
ahmad karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5141
Email address
ahmad.karami1993@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-07-02, 1398/04/11
Actual recruitment start date
2019-06-22, 1398/04/01
Actual recruitment end date
2019-08-02, 1398/05/11
Trial completion date
2019-11-22, 1398/09/01
Scientific title
The effect of an intervention based on Participatory Care Model on fatigue status patients with major thalassemia
Public title
The effect of an intervention based on Participatory Care Model on fatigue status patients with major thalassemia
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of thalassemia major approved by the hematologist and treated under regular care.
Exclusion criteria:
Unwillingness to continue participating in the study for any reason
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
122
Actual sample size reached:
112
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasouj University of Medical Sciences
Street address
Jahad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.YUMS.REC.1398.023
Health conditions studied
1
Description of health condition studied
Thalassemia
ICD-10 code
D55.3
ICD-10 code description
Anaemia due to disorders of nucleotide metabolism
Primary outcomes
1
Description
Fatigue status
Timepoint
At the beginning of the study and two months after the last training session
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group is randomly divided into 10 to 11 groups, and training sessions are held according to the stages of the collaborative care model. The first intervention (motivation) session is the best mechanism to motivate patients to be aware of the status quo and the potentially dangerous consequences and consequences of trying to communicate well with patients and get their medical history. The second session (preparation) provides them with a training schedule and also explains to the clients the nature of the visits (training sessions and follow-up), the duration of each visit and the purpose of the visits. The third session (first participatory educational visit), fourth and fifth (second and third educational participatory visit), sixth (first follow-up participatory visit), and seventh (second follow-up participatory visit) are the presence of clients. They are discussed. The eighth session is an evaluation intervention that conducts step by step evaluations at the beginning and end of each visit and in the final evaluation to assess the impact of implementing a collaborative care model on controlling for symptoms and symptoms, as well as changes in the patient's fatigue status by measuring instruments in the group. Intervention is measured.
Category
Lifestyle
2
Description
Control group: The intervention in the control group consisted of two training sessions in order to meet ethical standards.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Yasuj Hospital
Full name of responsible person
Ali Karam Alamdari
Street address
Jahad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 1223 3707
Email
Ahmad.Karami1993@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Alikaram Alamdari
Street address
Jahad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 1223 3707
Email
Ahmad.Karami1993@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Ahmad Karami
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Jahad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 1223 3707
Email
Ahmad.Karami1993@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ahmad Karami
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Jahad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 1223 3707
Email
Ahmad.Karami1993@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ahmad Karami
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Jahad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 1223 3707
Email
Ahmad.Karami1993@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
This study, after being approved at the Yasuj University of Medical Sciences and obtaining the necessary permissions to be accepted into the pop-fashion database and the ISI.
When the data will become available and for how long
Immediately after the approval of the college
To whom data/document is available
Yasouj University of Medical Sciences
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Ahmad karami
What processes are involved for a request to access data/document