Objective: Investigating the effect of applying continuous care model on lifestyle and quality of life in multiple sclerosis patients. Design: Randomized semi-experimental study with intervention and control groups. Sample size: 70 patients divided into two groups of intervention and control. Methods: multiple sclerosis patients who will visit Hamadan MS Association in 1392. Inclusion criteria: (a) patients without history of coronary and pulmonary diseases, psychiatric disorders or any other acute diseases with neurologist diagnosis; (b) Ages between 20 to 45 years; (c) Definite diagnosis of multiple sclerosis by a neurologist; (d) Settling in Hamadan for participating in educational sessions; (e) No visual and auditory defects with a specialist diagnosis; (f) At least six months history of disease. Exclusion criteria: (a) multiple sclerosis exacerbation or contracting another illness during the study; (b) Simultaneously contributing in other self-care programs which are affecting the life-style; (c) Patients with progressive-relapsing multiple sclerosis. Interventions: Patients in the intervention group will be educated according to continuous care model, in 8, one hour sessions, for 1 month and they will be followed for 2 months and the control group will receive routine care. Primary outcome: life’s quality will be evaluated in accordance with 54 items questionnaire of life’s quality of multiple sclerosis patients before, 1 month and 2 months after education. Secondary outcome: Lifestyle will be evaluated in accordance with questionnaire of lifestyle of multiple sclerosis patients, before, 1 month and 2 months after education.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013021112439N1
Registration date:2013-06-25, 1392/04/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-06-25, 1392/04/04
Registrant information
Name
Fatemeh Pakrad
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3131 4041
Email address
f_pakrad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice_chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-07-06, 1392/04/15
Expected recruitment end date
2013-10-07, 1392/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of applying continuous care model versus no intervention on lifestyle and quality of life in multiple sclerosis patients
Public title
The effect of continuous care on lifestyle and quality of life in multiple sclerosis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: (a) patients without history of coronary and pulmonary diseases, psychiatric disorders or any other acute diseases with neurologist diagnosis; (b) Ages between 20 to 45 years; (c) Definite diagnosis of multiple sclerosis by a neurologist; (d) Settling in Hamadan for participating in educational sessions; (e) No visual and auditory defects with a specialist diagnosis; (f) At least six months history of disease. Exclusion criteria: (a) MS exacerbation or contracting another illness during the study; (b) Simultaneously contributing in other self-care programs which are affecting the life-style; (c) Patients with progressive-relapsing multiple sclerosis.
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ethical Human Subject Review Board of Hamadan University of Medical Sciences
Street address
Hanmadan, Hamadan University of Medical Sciences
City
Hamadan
Postal code
Approval date
2013-04-10, 1392/01/21
Ethics committee reference number
16/35/9/49/پ/د
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
Quality of life in multiple sclerosis patients
Timepoint
Before intervention, one month and two months after intervention
Method of measurement
MSQoL-54 questionnaire
Secondary outcomes
1
Description
Lifestyle in multiple sclerosis patients
Timepoint
Before intervention, one month and two months after intervention
Method of measurement
Questionnaire of lifestyle of multiple sclerosis patients
Intervention groups
1
Description
Intervention group: in intervention group, patients will be divided into 3 groups based on their score of Expanded Disability Status Scale (EDSS). These 3 groups will be equalized based on type of MS, education, occupation, sex and age distribution and will be educated in accordance with continuous care model.
Category
Other
2
Description
Control group: in the control group the patients will be received only routine cares
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian hospital
Full name of responsible person
Fatemeh Ashtarani
Street address
Shahid Fahmideh Ave, Hamadan University of Medical Sciences
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Heidar Tavilani
Street address
Shaheed Fahmideh Ave, Hamadan University of Medical Sciences,
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of Research and Technology, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Fatemeh Ashtarani
Position
Postgraduate nursing student
Other areas of specialty/work
Street address
Shaheed Fahmideh Ave, Hamadan University of Medical Sciences, School of Nursing and Midwifery
City
Hamadan
Postal code
Phone
+98 81 1838 0574
Fax
Email
f.ashtarani@umsha.ac.ir; f_ashtarani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences, Nursing and Midwifery School
Full name of responsible person
Dr. Masuod Khodaveisi
Position
Phd of Nursing
Other areas of specialty/work
Street address
Shahid Fahmideh Ave, Nursing and Midwifery School, Department of Community Health Nursing, Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
+98 81 1838 0150
Fax
Email
khodaveisi@umsha.ac.ir
Web page address
www.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences, Nursing and Midwifery School
Full name of responsible person
Fatemeh Ashtarani
Position
Postgraduate Nursing student
Other areas of specialty/work
Street address
Shahid Fahmideh Ave, Hamadan University of Medical Sciences
City
Hamadan
Postal code
Phone
00
Fax
Email
f.ashtarani@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)