Protocol summary

Summary
(1) Objectives: The present study investigates the effect of collaborative care model on hope of multiple sclerosis patients and their caregivers. (2) Design: The present study design base on collaborative care model (3) Setting and conduct: 80 caregivers and 80 patients were selected according to inclusion criteria then caregivers and patients randomly will be divided into case and control groups. Baseline hope questionnaire completed before the intervention and then steps of collaborative care model will be engaged in case groups for 3 months. Hope scores 1 month after the intervention will be compared with pre-intervention data in case and control groups. (4) Participants including major eligibility criteria: Patient and caregivers member of Ahvaz multiple sclerosis society that have inclusion criteria. 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. (5) Intervention: Steps of collaborative care model including: motivation, preparation, involvement and evaluation will be engaged in case groups. (6) Main outcome measures (variables): Hope

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015051121474N2
Registration date: 2015-06-08, 1394/03/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-08, 1394/03/18
Registrant information
Name
Somaye Ganjalivand
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
stu1990206603@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of collaborative care model on hope of multiple sclerosis (M.S) patients and their caregivers
Public title
The effect of collaborative care model on hope of multiple sclerosis (M.S) patients and their caregivers
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 39 years old to 74 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 160
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
Ethics committee, Shiraz University of Medical Science
Street address
Ethics committee of Shiraz University of Medical Science, Shiraz University of Medical Science, Zand Street, Shiraz, Fars, Iran.
City
Shiraz
Postal code
Approval date
2015-03-02, 1393/12/11
Ethics committee reference number
ct_9379_7399

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
Hope
Timepoint
Before intervention and 1 month after intervention
Method of measurement
Snyder Hope Scale

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention groups, 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 groups 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, Jondishapour University of Medical Science, Golestan Road, Ahvaz, khuzestan, Iran.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Science
Full name of responsible person
Dr.Seyyed Basir Hashemi
Street address
Vice chancellor for research, Shiraz University of Medical Science, Zand Street, Shiraz, Fars, Iran.
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 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
Shiraz University of Medical Science
Full name of responsible person
Mahnaz Rakhshan
Position
PH.D in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Namazi Square, Shiraz, Fars, Iran.
City
Shiraz
Postal code
1978-71345
Phone
+98 71 3647 4254
Fax
Email
RAKHSHANM@SUMS.AC.IR
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz Univarsity of Medical Science
Full name of responsible person
Somaye Ganjalivand
Position
Master Science in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Namazi Square, Shiraz, Fars, Iran.
City
Shiraz
Postal code
1978-71345
Phone
+98 71 3647 4254
Fax
Email
SGANJALIVAND@YAHOO.COM
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz Univarsity of Medical Science
Full name of responsible person
Somaye Ganjalivand
Position
Master science in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Namazi Square, Shiraz, Fars, Iran.
City
Fars
Postal code
1978-71345
Phone
+98 71 3647 4254
Fax
Email
SGANJALIVAND@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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