This study is a clinical trial to evaluate the effectiveness of the participation of professional care based on self-care behaviors in patients with hepatitis B in the year 2015 in Ahwaz Imam Khomeini Hospital. Inclusion criteria for the study are: at least 6 months of diagnosis is past, age more than 18 years old; literacy; having advanced liver cancer and cirrhosis; participate in training sessions and lack of mental disorders. Exclusion criterion is not to participate in training sessions (two sessions of absenteeism and more). Sampling is random block recipients into two groups; intervention group (25 patients) and control (25 patients) are rendered homeless on the study and control groups did not begin training. In the training group, researcher and a clinical nurse of gastroenterology and 3 patients with hepatitis B that knowledge of other organizations to create the group; this pattern is based on the participation of the teaching profession. Model is a 4-step, first stage organized, the second stage determine the role of participatory, the third stage collaborative role and final stage evaluation empowerment. 4 sessions for 50-minutes is predicted. Inventory care to be filled by two groups after 4 weeks of the last session, and the results are compared with measurements.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021321056N1
Registration date:2015-04-02, 1394/01/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-02, 1394/01/13
Registrant information
Name
Fateme Hardani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3228 2838
Email address
hardani.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences
Expected recruitment start date
2015-03-11, 1393/12/20
Expected recruitment end date
2015-04-25, 1394/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of "professional partnership centered care," the self-care behavior in patients with hepatitis B
Public title
Self care in patients with hepatitis B
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. Patients with chronic hepatitis B by a specialist (at least the last 6 months of diagnosis.) Is confirmed. 2. Age over 18 years old. 3. Having the opportunity to attend training sessions or residing in Ahvaz. 4. literacy. 5. No risk of liver cancer and advanced cirrhosis. 6. In terms of mental and physical fitness have participated in training sessions. 7. The presence of a companion (who lives and works with the patient's follow-up treatment) in all training sessions.
Exclusion criterion: Participate in training sessions (two sessions of absenteeism and more)
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ahvaz Jundishapor University of Medical Sciences Ethics Committee
Street address
Ethics Committee, vice-chancellor for research and technology, Jundishapur University of Medical Sciences, Golestan street, Ahvaz
City
Ahvaz
Postal code
15794 - 61357
Approval date
2015-01-17, 1393/10/27
Ethics committee reference number
Ajums.REC.1393.367
Health conditions studied
1
Description of health condition studied
hepatitis B
ICD-10 code
B18.1
ICD-10 code description
Chronic viral hepatitis B without delta-agent Chronic (viral) hepatitis B
Primary outcomes
1
Description
Self care
Timepoint
Before the experiment, 4 weeks after the intervention.
Method of measurement
Self-care questionnaire in patients with hepatitis B
Secondary outcomes
empty
Intervention groups
1
Description
Patients in intervention group will receive 4 sessions training, each session lasting 50 minutes. The education team includes researchers, a nurse of gastroenterology and three of the patients with hepatitis B, that knowledge are higher than other patients. Education is about the illness and self-care behaviors. Based on the needs of patients the number and duration of sessions increases. Patients are evaluated after 2 weeks, if necessary training sessions will be repeated and to be empowered patients about self-care behaviors.
Category
Prevention
2
Description
Patients in the control group will receive routine hospital training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Ahvaz
Full name of responsible person
Fateme Hardani
Street address
Imam Khomeini Hospital, Azadegan St.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research and Technology, University of Ahvaz
Full name of responsible person
Dr. Syed Ahmad Hosseini
Street address
Ahvaz Jundishapur University of Medical Sciences, vice-chancellor for research and technology, Golestan street, Ahvaz, Khozestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research and Technology, University of Ahvaz
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
Ahvaz Jundishapor University of Medical Sciences
Full name of responsible person
Fateme Hardani
Position
MSc student of nursing education
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, nursing school, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
6177613616
Phone
+98 61 3228 2838
Fax
Email
hardani.f@ajums.ac.ir f.hardani7777@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nasrin Elahi
Position
Phd of Nursing, Faculty Member
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, nursing school, Golestan road, Ahvaz
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3373 8333
Fax
Email
Elahi_118@yahoo.com Elahi-N@ajum.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fateme Hardani
Position
MSc student of nursing education
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Postal code
61357-15749
Phone
+98 61 3333 3477
Fax
+98 61 3336 1544
Email
www.ajums.ac.ir hardani.f@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)