The effect of education program Self-Care based on theory of planned behavior of Control physical complications from the disease in patients with Multiple sclerosis
This quasi-experimental research, based on the before-after design is conducted in Qom MS Society aiming to investigate effectiveness of training the patients with Multiple Sclerosis in a self-care plan according to the theory of planned behavior on improving the symptoms. The research is done by permission of Qom University of Medical Science and approval from authorities of MS Society. A list of all members of Qom MS Society is checked prior to intervention and 80 patients were chosen as the sample based on inclusion criteria i.e. membership of MS Society, being between the ages of 18 and 50 and literacy as well as exclusion criteria i.e. taking the medicines to relieve the symptoms of the illness and less than 6 months of onset of the disease. The patients invited to participate in the research project are assigned to experimental and control groups at random. Following obtaining consent, the participants fill out personal information, self-care, self-report and constructs of the theory questionnaires. Training self-care plan classes then are designed according to Information obtained from questionnaires as well as specifying the participants’ difficulties. Three 45-minute training sessions based on the theory of planned behavior are conducted with merely the experimental group. Once we make sure that self-care plans are appropriately performed by participants, to keep evaluating proper performance of the plan within next 3 months after intervention, the monthly self-report questionnaires of trained items and issues are developed for 3 months the plan is being conducted to be filled out by the patients in experimental group. The questionnaires are collected and assessed after 3 months. It is of importance to point out that the witness group receives no intervention. The questionnaires are filled out again by the patients in both groups, 3 months after giving the training intervention is stopped, and questionnaires are analyzed afterwards. Such symptoms of the Multiple Sclerosis as constipation, muscle spasms, Forgetfulness and Fatigue are predicted to subside following training self-care plan.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071628957N1
Registration date:2016-12-17, 1395/09/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-17, 1395/09/27
Registrant information
Name
Zahra Dashti
Name of organization / entity
Qom University of Medical Sciences and Health Services- School of Public Health
Country
Iran (Islamic Republic of)
Phone
+98 25 3280 4089
Email address
z.dashti91@yahoo.com
Recruitment status
Recruitment complete
Funding source
MS Society of Qom province
Expected recruitment start date
2016-08-05, 1395/05/15
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education program Self-Care based on theory of planned behavior of Control physical complications from the disease in patients with Multiple sclerosis
Public title
The effect of education program Self-Care to control physical complications resulted from multiple sclerosis
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: being between the ages of 18 and 50; literacy; not being wheelchair-dependent; not being at Severe stage of the disease; giving consent to participate in the study; not having mental disorders; membership of MS Society.
Exclusion criteria: taking the medicines to relieve the symptoms of the Multiple Sclerosis; taking part in training self-care programs during 6 months ago; developing other acute or chronic physical illnesses (like debilitating Cardiovascular, Respiratory tract, liver, skeletal muscle and renal diseases); less than 6 months of onset of the disease
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
After the sample selection based on inclusion criteria, patients randomly are placed in two intervention and control groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences and Health Services
The physical complications of multiple sclerosis in 4 areas constipation, muscle cramps, fatigue and Amnesia
Timepoint
Before the intervention, one month, two months, three months after the intervention.
Method of measurement
Self-report Questionnaire (according to score)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: only experimental group undergoes the intervention within 3 theoretical and practical 45-minute training sessions according to the theory of planned behavior. After being certain about correct performance of self-care plans by experimental group, the plan will be conducted for 3 months. Various training methods including lecture, group discussion, Socratic and role-playing methods are going to be utilized in these sessions. Besides, the patients benefit telephone consultations.
Category
Behavior
2
Description
Control group: no action
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
MS Society of Qom province
Full name of responsible person
Zahra Dashti
Street address
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
MS Society of Qom province
Full name of responsible person
Zahra Dashti
Street address
Clinic Baqiyatallah - St. Dvrshhr
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
MS Society of Qom province
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
Qom University of Medical Sciences and Health Services- School of Public Health
Full name of responsible person
Zahra Dashti
Position
Masters student Health Education
Other areas of specialty/work
Street address
Plak 21 - Alley 11 - St. Alborz - St. citizen - Pardisan
City
Qom
Postal code
Phone
+98 25 3280 4089
Fax
Email
z.dashti91@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom University of Medical Sciences and Health Services- School of Public Health
Full name of responsible person
Siamak Mohebi
Position
PHD Health Education
Other areas of specialty/work
Street address
School of Public Health - Plaza Ruhollah
City
Qom
Postal code
Phone
+98 25 3773 6017
Fax
Email
z.dashti91@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qom University of Medical Sciences and Health Services- School of Public Health
Full name of responsible person
Zahra Dashti
Position
Masters student Health Education
Other areas of specialty/work
Street address
City
Qom
Postal code
Phone
+98 25 3280 4089
Fax
Email
z.dashti91@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)