The effect of an educational-supportive program based on chronic care model on self-efficacy and health related quality of life of patients with ulcerative colitis
Determining the effect of an educational-supportive program based on chronic care model(CCM) on self-efficacy and health related quality of life(HRQOL) of patients with ulcerative colitis(UC)
Design
This study is a clinical trial with control group, two stages as a before and after test on 70 patients, a blind (statistical analyzer), randomized by randomized block method.
Settings and conduct
The environment of this research is described by Poorsina Hakim Gastroenterology Clinic located in Isfahan Health Town and how to do it in the intervention groups section.
Participants/Inclusion and exclusion criteria
Definitive diagnosis of UC
6 months after the diagnosis of UC and the stability of the drug phase during the study
Age 18 to 65 years
Not having confirmed mental illnesses
Not having other chronic diseases
Not having Primary sclerosing cholangitis (inflammation of bile ducts)
Intervention groups
In this program, based on 4 components of the chronic care model, interventions are performed, which include delegating the task of teaching and reminding and supervising the practice of trainings, answering questions and taking patients' histories, from doctor to nurse, in addition to following tests, procedures. , Patient status between visits and active management of the time of the doctor's appointment with the nurse, educating the patient and providing various educational resources and psychosocial support through dialogue with peers, answering patients' questions based on the results of recent studies in the field of UC and attention to their preferences to decide on treatment and care and electronic registration of information and patient history. The control group is visited only by a physician and does not receive training or support from a nurse.
Main outcome variables
the health related quality of life and self-efficacy of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170731035424N2
Registration date:2021-09-19, 1400/06/28
Registration timing:registered_while_recruiting
Last update:2021-09-19, 1400/06/28
Update count:0
Registration date
2021-09-19, 1400/06/28
Registrant information
Name
Sedigheh Farzi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7565
Email address
sedighehfarzi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-02, 1400/05/11
Expected recruitment end date
2021-10-18, 1400/07/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an educational-supportive program based on chronic care model on self-efficacy and health related quality of life of patients with ulcerative colitis
Public title
The effect of an educational-supportive program on self-efficacy and quality of life of patients with ulcerative colitis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of ulcerative colitis With the approval of a specialist doctor and the results of colonoscopy and pathology
6 months after the diagnosis of ulcerative colitis and the stability of the drug phase during the study according to the doctor diagnose
Willingness to participate in the study
Not participating in the same study at the same time
The ability to use WhatsApp software by the patient or his primary caregiver
The possibility of making a telephone call to the patient
Age 18 to 65 years
Having the ability to understand Persian language
Exclusion criteria:
having confirmed mental illnesses (according to the patient and family statements)
Having other chronic diseases
Having Primary sclerosing cholangitis (inflammation of bile ducts)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Before entering the study, the samples are divided into 8 groups, which are 4 groups of women with age group under 30 years, 30 to 40 years, 40 to 50 years, 50 years and above and 4 groups of men with the same division classification in terms of age. Then, randomly in each of the 8 groups, individuals are assigned to the control or intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer will not know which of the two intervention and control groups the data under analysis belongs to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Science
Street address
Hezar-Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Approval date
2021-07-14, 1400/04/23
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.049
Health conditions studied
1
Description of health condition studied
Ulcerative Colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Self-efficacy score based on Strategies Used by People to Promote Health questionnaire
Timepoint
Before the intervention, immediately and 3 months after the end of the intervention
Method of measurement
Strategies Used by People to Promote Health questionnaire
2
Description
Health-related quality of life score based on Inflammatory Bowel Disease Questionnaire(IBDQ-9)
Timepoint
Before the intervention, immediately and 3 months after the end of the intervention
Method of measurement
Inflammatory Bowel Disease Questionnaire (IBDQ-9)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: the intervention group has a program containing 4 components of the chronic care model, including redesign of the care delivery system, self-management support, decision support, and the clinical information system or system which includes interventions such as delegating training and reminders and monitoring the practice of training, Answering questions and taking patients' histories, from doctor to nurse, in addition to following up on tests, procedures, patient status between visits and active management of the doctor's appointment with the nurse, educating the patient and providing various educational resources and psychosocial support Through conversations with peers, answering patients' questions is based on the results of recent studies in the field of ulcerative colitis and attention to their preferences for decisions about treatment and care and electronic recording of patient information and history.
Category
Lifestyle
2
Description
Control group: the control group will have only regular visits to the doctor as usual.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Poursina Hakim clinic
Full name of responsible person
Abdolmehdi Baghaei
Street address
Aghababaei Expy
City
Isfahan
Province
Isfehan
Postal code
Level 3, Building No
Phone
+98 31 3554 8151
Email
info@poursinahakim.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Hezar-Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174- 73461
Phone
+98 31 3792 2414
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Sedigheh Farzi
Position
Faculty of Isfahan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan Faculty of Nursing and Midwifery, Department of Adult Health Nursing
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 7589
Email
Sedighehfarzi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Sedigheh Farzi
Position
Faculty of Isfahan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan Faculty of Nursing and Midwifery, Department of Adult Health Nursing
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 7589
Email
Sedighehfarzi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Sedigheh Farzi
Position
Faculty of Isfahan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan Faculty of Nursing and Midwifery, Department of Adult Health Nursing
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 7589
Email
Sedighehfarzi@nm.mui.ac.ir
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
Yes - There is 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
By maintaining the confidentiality of participants' personal characteristics, the results of the study are shared based on the objectives of the study.
When the data will become available and for how long
Access will start immediately after the results are published in reputable journals
To whom data/document is available
If a request is sent to the responsible author of the article, due to the confidentiality of the participants' information, the decision on access to the results will be made.
Under which criteria data/document could be used
If a request is sent to the responsible author of the article, due to the confidentiality of the participants' information, the use of the data will be decided.
From where data/document is obtainable
people can correspond with the responsible author via the email contained in the article to receive data.
What processes are involved for a request to access data/document
A request can be made by correspondence with the responsible author of the article via email.