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The impact of management training on self-efficacy and quality of life of patients with Ulcerative colitis

Protocol summary

Summary
The effect of self- management training on self- efficacy and quality of life of patients with Ulcerative colitis: A total of 84 patients with a confirmed diagnosis of Ulcerative colitis will enroll in this study. The experiment will be done in Motahari Clinic in Shiraz, using a clinical trial. First, the study sample will be selected based on convenient sampling. Then, it will be randomized to one group that will receive the intervention being studied (the experimental group) and another group that will not receive the intervention (the control group). The intervention group will receive self-management training in six 90-minute sessions for a month. Training sessions include familiarity with the disease, ways to control the symptoms, the correct principles of nutrition, medication, cognitive therapy techniques, problem solving, decision- making and strengthen the positive abilities. After the intervention, the intervention group will use self-management training for a month. During this time, researcher will has four telephone consultation with them. Information will be collected via SUPPH questionnaire and Inflammatory Bowel Disease Questionnaire-9 (IBDQ-9). Two groups will be formed by questionnaires before, immediately after and four weeks after the intervention. Inclusion criteria: The definitive diagnosis of Ulcerative colitis by a specialist, and colonoscopy results; Age greater than 18 and less than 65 years; Having the ability to understand the language of Farsi; The possibility of making a phone call with patients; Willingness to participate in research; No other chronic diseases; Residence in Shiraz or the possibility of attending meetings; Lack of mental disease has been confirmed (according to the patient and family talk) Exclusion criteria: Conditions acute illness; Lack of presence in over two sessions; patient's lack of cooperation during the investigation

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092429823N1
Registration date: 2016-11-09, 1395/08/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-11-09, 1395/08/19
Registrant information
Name
Sakine Jaafari
Name of organization / entity
Hazrat-e-Fatemeh nursing and midwifery college
Country
Iran (Islamic Republic of)
Phone
+98 71 3622 0235
Email address
stud2280469413@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research , Shiraz University of Medical Sciences
Expected recruitment start date
2016-10-27, 1395/08/06
Expected recruitment end date
2016-11-26, 1395/09/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of management training on self-efficacy and quality of life of patients with Ulcerative colitis
Public title
The impact of self-management education for patients with Ulcerative colitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The definitive diagnosis of Ulcerative colitis by a specialist, and colonoscopy results; Age greater than 18 and less than 65 years; Having the ability to understand the language of Farsi; The possibility of making a phone call with patients; Willingness to participate in research; No other chronic diseases; Residence in Shiraz or the possibility of attending meetings; Lack of mental disease has been confirmed (according to the patient and family talk) Exclusion criteria: Conditions acute illness; Lack of presence in over two sessions; patient's lack of cooperation during the investigation
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Simple randomization is used in this study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical sciences, Zand Street, Shiraz
City
Shiraz
Postal code
14336-71348
Approval date
2016-07-17, 1395/04/27
Ethics committee reference number
IR.SUMS.REC.1395.87

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
Timepoint
Before training (intervention), immediately after training and one month after training
Method of measurement
Strategies Used by People to Promote Health

2

Description
Quality of Life
Timepoint
Before training (intervention), immediately after training and one month after training
Method of measurement
Inflammatory Bowel Disease Questionnaire-9 (IBDQ-9)

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will receive self-management training in six 90-minute sessions for a month. Training sessions include familiarity with the disease, ways to control the symptoms, the correct principles of nutrition, medication, cognitive therapy techniques, problem solving, decision- making and strengthen the positive abilities. After the intervention, the intervention group will use self-management training for a month. During this time, researcher will has four telephone consultation with them.
Category
Other

2

Description
The control group will not receive training, at the end of study, training manual given to them.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Motahari Clinic
Full name of responsible person
Sakine Jaafari; Master of Science Nursing Student
Street address
Shiraz Motahari Clinic; Namazi Square; Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research , Shiraz University of Medical Sciences
Full name of responsible person
Seyyed Basir Hashemi
Street address
Vice chancellor for research, 7th floor , Central Building of Shiraz University of Medical Sciences,Zand Street, Shiraz
City
Shiraz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research , Shiraz 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
Shiraz University of Medical Sciences-Hazrat-e- Fatemeh nursing and midwifery college
Full name of responsible person
Sakine Jaafari
Position
Master of Science Nursing Student
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi hospital, Namazi Squer, Shiraz
City
Shiraz
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
nurs_midwif@sums.ac.ir
Web page address
nurs_midwif.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hazrat-e-Fatemeh nursing and midwifery college, Namazi hospital, Namazi Squer, Shiraz
Full name of responsible person
Sakine Jaafari
Position
Master of Science Nursing Student
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi hospital, Namazi Squer, Shiraz
City
Shiraz
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
nurs_midwif@sums.ac.ir
Web page address
nurs_midwif.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences-Hazrat-e- Fatemeh nursing and midwifery college
Full name of responsible person
Sakine Jaafari
Position
Master of Science Nursing Student
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Squer,Shiraz
City
Shiraz
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
nurs_midwif@sums.ac.ir
Web page address
nurs_midwif.sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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