Protocol summary

Summary
The present study investigates the effect of collaborative care model on self-efficacy of multiple sclerosis patients. 80 patients were selected according to inclusion criteria including: age between 20 and 55 years, confirmed multiple sclerosis disease by a neurologist and expanded disability status score between 2 to 3. Exclusion criteria including: pregnancy and increase in expanded disability status score at least 1 point with relapse or progression of the disease. After selecting samples, patients randomly will be divided into case and control groups. Baseline demographic and self-efficacy questionnaires completed before the intervention and then steps of collaborative care model including: motivation, preparation, involvement and evaluation will be engaged in case group for 3 months. self-efficacy scores 1 month after the intervention will be compared with pre-intervention data in case and control groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013021212248N2
Registration date: 2013-06-11, 1392/03/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-11, 1392/03/21
Registrant information
Name
Meysam Chahkhoie Mehdiabad
Name of organization / entity
Bam University of Medical Science.
Country
Iran (Islamic Republic of)
Phone
+98 34 4221 7360
Email address
chahkhoei.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Science
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using collaborative care model on self-efficacy of multiple sclerosis (MS) patients.
Public title
The effect of collaborative care model on self-efficacy of MS patients.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: multiple sclerosis disease confirm by a neurologist ; expanded disability status scale between 2 to 3. Exclusion criteria: pregnancy ; increase in expanded disability status score at least 1 point with relapse or progression of the disease.
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
N/A
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 Jundishapur University of Medical Science
Street address
Jundishapur University of Medical Science, Golestan Road, Ahvaz, Khuzestan, Iran.
City
Ahvaz
Postal code
Approval date
2012-07-15, 1391/04/25
Ethics committee reference number
ETH-666

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system

Primary outcomes

1

Description
Self-efficacy
Timepoint
Before intervention and 1 month after intervention
Method of measurement
Sherer et al general self-efficacy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, education based on steps of collaborative care model including: Motivation, Readying, Involvement and Evaluation will be used for 3 month.
Category
N/A

2

Description
Control group receive no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Khuzestan MS Society
Full name of responsible person
Dr. Nastaran Majdinasab
Street address
Khuzestan MS Society, Faculty of Rehabilitation, Jundishapur University of Medical Science, Golestan Road, Ahvaz, Khuzestan, Iran.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Abdolali Shariati
Street address
Faculty of Nursing and Midwifery, Jondishapour University of Medical Science, Golestan Road, Ahvaz, Khuzestan, Iran.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Science
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 Jundishapur Univarsity of Medical Science
Full name of responsible person
Abdolali Shariati
Position
Master science in nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Jundishapur University of Medical Science, Golestan Road, Ahvaz, Khuzestan, Iran.
City
Ahvaz
Postal code
Phone
+98 61 1373 8331
Fax
+98 61 1373 8333
Email
Shsh_Ali2003@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur Univarsity of Medical Science
Full name of responsible person
Meysam Chahkhoei Mehdiabad
Position
Master science in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Jundishapur University of Medical Science, Golestan Road, Ahvaz, Khuzestan, Iran.
City
Ahvaz
Postal code
Phone
+98 61 1373 8331
Fax
Email
Chahkhoei.m@ajums.ac.ir, Halopridol2@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Science
Full name of responsible person
Meysam Chahkhoie Mehdiabad
Position
Master science in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Jondishapour University of Medical Science, Golestan Road, Ahvaz, Khuzestan, Iran.
City
Ahvaz
Postal code
Phone
+98 61 1373 8331
Fax
Email
Chahkhoei.m@ajums.ac.ir,Halopridol2@yahoo.com
Web page address

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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