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The effect of education and telephone follow-up on self-care and quality of life in patients with multiple sclerosis

Protocol summary

Study aim
Improving self-care and quality of life in patients with multiple sclerosis
Design
Clinical trial with control group, with parallel groups, One-way blind, randomized by Random number table, on 60 patients
Settings and conduct
The place of association of MS patients of Arak city is through face-to-face training and telephone follow-up. Blindness Statistics Consultant
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive diagnosis of the disease by a specialist physician in clinical, laboratory and pathological terms, full knowledge of the patient's diagnosis, age 19-55 years, access to telephone at home, lack of speech and hearing problems, literacy, minimum passing Six months after the doctor's definitive diagnosis, ability to perform self-care activities, satisfaction and interest in participating in the study. Exclusion criteria - History of other chronic diseases from the point of view of a specialist doctor and hospitalization during the study, acute stage of the disease with a specialist doctor, mental retardation, disconnection of telephone for 3 weeks in the 2nd and 3rd months of intervention, unwillingness to Continue cooperation.
Intervention groups
Two sessions of self-care training program (1 - 1.5 hours each session), for 2 weeks by the researcher, in the form of face-to-face training with questions and answers in groups of 5 to 6 people will be performed for members of the control and experimental group by a trained nursing expert. In the experimental group, telephone intervention will be performed for 12 weeks. Thus, telephone calls in the experimental group are made twice a week in the first month and once a week during the second and third months to follow the recommended self-care skills.
Main outcome variables
Self-care

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211128053205N1
Registration date: 2022-02-04, 1400/11/15
Registration timing: registered_while_recruiting

Last update: 2022-02-04, 1400/11/15
Update count: 0
Registration date
2022-02-04, 1400/11/15
Registrant information
Name
leila jamehbozorgi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
jamehbozorgi.71@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education and telephone follow-up on self-care and quality of life in patients with multiple sclerosis
Public title
The effect of education and telephone follow-up on self-care and quality of life in patients with multiple sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis by a specialist physician clinically, laboratory and pathologically the client is fully aware of the diagnosis of his disease age 19-55 years, access to telephone at home, lack of speech and hearing problems literacy at least six months have passed Definitive diagnosis of a physician ability to perform self-care activities satisfaction and interest in participating in the study.
Exclusion criteria:
History of other chronic diseases such as hypertension, diabetes, chronic liver disease (Wilson, primary hemochromatosis, etc.), hyperthyroidism or hypothyroidism, tuberculosis, cardiovascular disorders, respiratory, gastrointestinal, metabolic, cancer acute stage of the disease from the point of view of a specialist, mental retardation
Age
From 19 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be selected by available sampling method. In order to assign the samples to the control and intervention groups, the stratified random block method (sex and age) will be used. The size of the blocks will be 4 people according to the number of groups and 4 people will be placed in each group and a random list was created using the online BlockRandomization software (https://www.sealedenvelope.com/simple -randomiser / v1 / lists).
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding is a statistical expert who will analyze data without knowing the study groups.
Placebo
Not used
Assignment
Single
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
Arak, Basich Square, Payambar Azam (PBUH) University Complex, Vice Chancellor for Research and Technology, Medical Research and Information Management
City
arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2021-11-24, 1400/09/03
Ethics committee reference number
IR.ARAKMU.REC.1400.213

Health conditions studied

1

Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
quality of life of patients
Timepoint
(Before the intervention) and 120 days after the intervention
Method of measurement
MSIS-29 Quality of Life Questionnaire

Secondary outcomes

1

Description
Self-Care
Timepoint
Initiation of intervention and 120 days after intervention
Method of measurement
Miller Self-Care Questionnaire

Intervention groups

1

Description
Intervention group: Two sessions of self-care training program (1 - 1.5 hours each session), for 2 weeks by the researcher, in the form of face-to-face training with questions and answers in groups of 5 to 6 about self-care skills of sensory dysfunction, memory loss, fatigue Chronic, muscle cramps, improved nutrition, type of exercise and sexual dysfunction Disorders of urination, stool and constipation for intervention members will be done by a trained nursing expert. In the experimental group, telephone intervention will be performed for 12 weeks
Category
Lifestyle

2

Description
Control group: Two sessions of self-care training program (1 - 1.5 hours each session), for 2 weeks by the researcher, in the form of face-to-face training with questions and answers in groups of 5 to 6 about self-care skills of sensory dysfunction, reduction Memory, chronic fatigue, muscle cramps, improved nutrition, type of exercise and sexual dysfunction Disorders of urination, defecation and constipation for members of the control group will be done by a trained nursing expert.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
MS Arak Association
Full name of responsible person
Moloud Farmahini Farahani
Street address
Arak - Shahid Shiroodi St. - Alam al-Huda St.
City
arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
jamehbozorgi.71@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Moloud Farmahini Farahani
Street address
Arak - Shahid Shiroodi St. - Alam al-Huda St.
City
arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
jamehbozorgi.71@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Moloud Farmahini Farahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arak - Shahid Shiroodi St. - Alam al-Huda St.
City
Arak - Shahid Shiroodi St. - Alam al-Huda St.
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
jamehbozorgi.71@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Moloud Farmahini Farahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arak - Shahid Shiroodi St. - Alam al-Huda St.
City
arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
jamehbozorgi.71@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Moloud Farmahini Farahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arak - Shahid Shiroodi St. - Alam al-Huda St.
City
arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
jamehbozorgi.71@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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