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The effect of family-centered training from distance on quality of life and sleep quality in multiple sclerosis patients

Protocol summary

Study aim
The effect of family-centered training from distance on quality of life and sleep quality in multiple sclerosis patients is determined.
Design
A clinical trial with a control group, not blind, randomized, on 70 patients
Settings and conduct
This research is a randomized clinical trial study with a control group. The statistical population is patients with multiple sclerosis referred to the MS Association of Arak city in 1401.
Participants/Inclusion and exclusion criteria
MS patients entry: Completing the consent form, A definite diagnosis of MS for at least 6 months by a neurologist, Age 18-65 years, Living with family, Not having a private nurse, not receiving similar intervention at the same time, Not having hearing, vision, speech problems, Not taking Psychiatric and sleeping drugs, Not having psychological problem, Not suffering from debilitating diseases. family member: Completing the consent form, Age over 18 years, having minimum literacy to read and write, Living with the patient and being a member of the patient's family and access to smart phones, internet and the ability to work with them; Exit: Death of the patient or active family member, long-term hospitalization, Failure to complete questionnaires or filling them incompletely, Unwillingness to continue cooperation and death a family member in the last 6 months
Intervention groups
The members of the intervention group (active family members) will be members of WhatsApp and Telegram groups managed by the researcher and Educational content is provided to members twice a week for 6 weeks. The researcher will call them once a week
Main outcome variables
Quality of life, Sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221211056774N1
Registration date: 2022-12-15, 1401/09/24
Registration timing: prospective

Last update: 2022-12-15, 1401/09/24
Update count: 0
Registration date
2022-12-15, 1401/09/24
Registrant information
Name
Fatemeh Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4636 8223
Email address
f.hashemi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-11, 1401/10/21
Expected recruitment end date
2023-01-28, 1401/11/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered training from distance on quality of life and sleep quality in multiple sclerosis patients
Public title
The effect of family-centered training from distance on quality of life and sleep quality
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Completing the consent form of patients to participate in the study A definite diagnosis of multiple sclerosis for at least 6 months by a neurologist Age between 18-65 years Living with family Not having a private nurse Not receiving the same intervention at the same time Not having hearing, vision and speech problems No use of Psychiatric and sleeping drugs Not having a psychological problem Not suffering from other debilitating diseases Entry criteria for an active family member include completing the consent form to participate in the study Age over 18 years Having minimum literacy to read and write Living with the patient and being a member of the patient's family (father, mother, sister, brother, child and spouse) Access to smart phones, internet and social networks and the ability to work with them
Exclusion criteria:
Death of the patient or active family member during the study Long-term hospitalization Failure to complete study questionnaires or filling them incompletely Unwillingness to continue cooperation Death of a family member in the last 6 months
Age
From 18 years old to 65 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
At first, samples will be selected as available.Then, patients will be divided into two control and intervention groups using permutation block randomization. According to the sample size, blocks with a capacity of 4 units will be considered. By assigning the letter A to the intervention group and the letter B to the control group, there are six states AABB, BBAA, BABA, ABBA, BAAB and ABAB. Then it is randomly selected from among these situations and a list equal to the sample size is prepared for patients before the start of the study .For better randomization, the web software will be used to prepare the randomization list, which creates random permutations for both types of treatment in each block, and according to the change of permutations in each block, concealment is also observed. During the implementation of the study, the predictability of the treatment for each patient is reduced by the researcher. Site used for random permutation block method: https://www.sealedenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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
Management of Research and Medical Information, Deputy of Research and Technology, University Complex of the Prophet (pbuh), Basij Square
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2022-12-10, 1401/09/19
Ethics committee reference number
IR.ARAKMU.REC.1401.214

Health conditions studied

1

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

Primary outcomes

1

Description
Quality of life
Timepoint
Before the start of the intervention and 30 days after the end of the intervention
Method of measurement
Multiple sclerosis Quality of life questionnaire for MS patients(MSIS-29)

2

Description
Sleep quality
Timepoint
Before the start of the intervention and 30 days after the end of the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The members of the intervention group who are active members of the family will be members of WhatsApp and Telegram groups managed by the researcher, and educational content will be provided to them in the form of text.The researcher will answer the family member's questions in this way or by phone call. During the delivery of educational content, the researcher will ensure that the messages are read and viewed, by calling members and asking a few questions throughout the week. In the intervention group, educational content will be provided to the members twice a week for 6 weeks (generally 12 sessions) and they will be contacted by phone once a week.
Category
Lifestyle

2

Description
Control group: The control group will receive only routine community support. In order to comply with ethical considerations, at the end of the research, the members of the control group will also become its members to use the educational content of social networks.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak MS Association
Full name of responsible person
Fatemeh Hashemi
Street address
Arak MS Association, Farabi Street, Razavi town
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
F.hashemii1991@gmail.com
Web page address
http://markazi-ms.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mehdi Salehi
Street address
Deputy of Research and Technology, University complex of the great prophet (pbuh), Basij Squere, Sardasht
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
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
Fatemeh Hashemi
Position
Nursing master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Second floor, Nursing College, Arak University of Medical Sciences, Basij Squere, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
F.hashemii1991@gmail.com
Web page address
https://arakmu.ac.ir

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
Second floor, Faculty of Nursing, Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
farmahini70@gmail.com
Web page address
https://arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Hashemi
Position
Nursing master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Second floor, Faculty of Nursing, Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
F.hashemii1991@gmail.com
Web page address
https://arakmu.ac.ir

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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