Comparing the impact of education based on traditional methods and Planned Behavior Theory on Treatment Adherence in Patients with Multiple Sclerosis Receiving Injectable Immunomodulatory Drugs
Determining the effect of educational intervention on the mean score of 1.behavioral beliefs
2.principled beliefs
3.controlled beliefs
about drug adherence to multiple sclerosis inject able immuno-modulatory drugs in the intervention and control groups
4.Determining the effect of educational intervention on the mean score of behavioral intention regarding the promotion of drug adherence to multiple sclerosis inject able immuno-modulatory drugs in the intervention and control groups
5.Determining the effect of educational intervention on the mean score of drug adherence using drug adherence questionnaire in MS patients in the intervention and control groups
Design
Clinical trial with control group, with parallel, randomized groups, on 100 patients. Easy sampling was used for randomization.
Settings and conduct
The patients who referred to the MS clinic of Sina Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients with Relapsing remitting Multiple Sclerosis
2. Patients treated with Rebif for at least one to four years
3- Patients who have the ability to read and write.
4. Patients with low drug adherence.
5- Patients who want to receive education.
6- ages of 20 to 50 years
7- Patients living in Tehran
Exclusion criteria: 1- Patient's dissatisfaction to continue participating in the study
2 - Absence in face-to-face educational intervention sessions
3- Changes in the patient's treatment plan and not receiving Rebif medicine
Intervention groups
Education based on the theory of planned behavior to promote drug adherence in patients with multiple sclerosis who are treated with Rebif and have low drug adherence.
Main outcome variables
Evaluation of
1. drug adherence
2. behavioral & principled and controlled beliefs
3. behavioral intention
4. performance
scores in MS patients treated with Rebif before and after the intervention in the both groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210808052109N1
Registration date:2021-08-12, 1400/05/21
Registration timing:prospective
Last update:2021-08-12, 1400/05/21
Update count:0
Registration date
2021-08-12, 1400/05/21
Registrant information
Name
Sara Hamtaei Ghashti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3431 7737
Email address
sarah.hamtaee@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the impact of education based on traditional methods and Planned Behavior Theory on Treatment Adherence in Patients with Multiple Sclerosis Receiving Injectable Immunomodulatory Drugs
Public title
Investigating the effect of education on Multiple Sclerosis patients' drug adherence
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Relapsing Remitting Multiple Sclerosis Patients
Be treated with interferon beta-1a(Rebif) at least one to four years
Exclusion criteria:
Patient dissatisfaction to continue participating in the study
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is easy and patients will be selected based on inclusion criteria.The selected patients will then be divided into two equal groups using block randomization method.The size of the blocks is four and they will be selected from six four-block blocks by random selection by placing samples and will be assigned to two groups.
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 of Arak University of Medical Sciences
Street address
Alamolhoda Avenue -Shahid Shirodi Avenue - Arak
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2021-08-01, 1400/05/10
Ethics committee reference number
IR.ARAKMU.REC.1400.082
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
ICD-10 code description
Relapsing Remitting Multiple Sclerosis
Primary outcomes
1
Description
Determining the effect of education based on the theory of planned behavior on the promotion of drug adherence in patients with multiple sclerosis treated with modulatory drugs, beta 1a interferons, which are injected subcutaneously.
Timepoint
Patients are first given a drug compliance questionnaire. Patients are instructed and after three months, a drug compliance questionnaire will be taken from these patients again and the effectiveness of the training will be measured.
Method of measurement
To assess adherence to treatment, two questionnaires are used: 1 - Multiple Sclerosis Treatment Adherence Questionnaire 2- Theoretical questionnaire to assess the impact of the curriculum on the structures of the planned behavior theory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine training, training with the theory of planned behavior will be done based on the initial needs assessment. To transfer the training with the theory of planned behavior, a video of how to inject the drug is delivered to the patient at the same time as the routine training. 1- In addition to all the preliminary steps of the drug storage method 2- Preparing the drug for injection 3- Necessary measures before injecting the drug 4- Suitable places in the body for injecting the drug 5- Methods of controlling the unwanted side effects of the drug after injecting it in the mentioned video It is placed at the disposal of patients. In addition, all the above five items are provided to patients in a colored educational pamphlet.
Category
Behavior
2
Description
Control group: The control group will also receive routine clinical training provided by nurses and clinic staff. Routine training in the MS clinic includes training on how to inject the drug into the appropriate injected tissues, which is a practical training on injecting a dose of the drug into the body. The patient is by the nurse.