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The effect of participating in support groups on social frailty and balance confidence among community-dwelling older adults

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History
# Registration date Revision Id
2 2025-05-14, 1404/02/24 340619
1 2024-04-29, 1403/02/10 300137
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  • Protocol summary

    A randomized clinical trial with two intervention and control groups will be conducted on 176 elderly people who meet the inclusion criteria. Allocation of participants to intervention and control groups will be done by random block allocation method.
    A randomized clinical trial with two intervention and control groups will be conducted on 132 elderly people who meet the inclusion criteria. Allocation of participants to intervention and control groups will be done by random block allocation method.
    کارازمایی بالینی تصادفی شده دارای دو گروه مداخله و کنترل که بر روی 176 سالمند دارای معیارهای ورود انجام خواهد شد. تخصیص افراد به گروه های مداخله و کنترل به روش تخصیص تصادفی بلوکی انجام خواهد شد.
    کارازمایی بالینی تصادفی شده دارای دو گروه مداخله و کنترل که بر روی 132 سالمند دارای معیارهای ورود انجام خواهد شد. تخصیص افراد به گروه های مداخله و کنترل به روش تخصیص تصادفی بلوکی انجام خواهد شد.
    The place of study will be comprehensive health centres in south of Tehran affiliated to Tehran University of Medical Sciences. The initial sampling will be done by convenience sampling method. Then, 176 elderly people who meet the inclusion criteria will be allocated to two groups of intervention (88 people) and control (88 people) by random block allocation method. blinding will not be done.
    The place of study will be comprehensive health centres in south of Tehran affiliated to Tehran University of Medical Sciences. The initial sampling will be done by convenience sampling method. Then, 132 elderly people who meet the inclusion criteria will be allocated to two groups of intervention (66 people) and control (66 people) by random block allocation method. blinding will not be done.
    محل انجام مراکز جامع سلامت جنوب تهران وابسته به دانشگاه علوم پزشکی تهران خواهند بود. تعداد 176 نفر از سالمندان به روش دردسترس وارد مطالعه خواهند شد سپس به روش تخصیص تصادفی بلوکی به دو گروه مداخله و کنترل تخصیص داده خواهند شد که هر گروه شامل 88 سالمند خواهد بود و کورسازی انجام نخواهد شد.
    محل انجام مراکز جامع سلامت جنوب تهران وابسته به دانشگاه علوم پزشکی تهران خواهند بود. تعداد 132 نفر از سالمندان به روش دردسترس وارد مطالعه خواهند شد سپس به روش تخصیص تصادفی بلوکی به دو گروه مداخله و کنترل تخصیص داده خواهند شد که هر گروه شامل 66 سالمند خواهد بود و کورسازی انجام نخواهد شد.

  • General information

    176
    132
    empty
    Considering the interim analysis, the lack of access to a larger sample size, and the limitations of the study, as well as the need to save time and resources, the sample size was reduced to 132 participants after the interim analysis and with the approval of the statistical advisor.
    empty
    تغییر تعداد نمونه : با توجه به انجام آنالیز میانی، عدم دسترسی به تعداد نمونه بیشتر و محدودیت های پژوهش و صرفه جویی در وقت و منابع پس از انجام آنالیز میانی و تایید مشاور محترم آمار تعداد نمونه ها به 132 نفر تغییر کرد.
    سالمندان دارای معیارهای ورود به روش تخصیص تصادفی بلوکی به دو گروه مداخله و کنترل تخصیص داده خواهند شد برای این منظور از بلوک های شش تایی تولید شده در سایت www.randomizer.org استفاده خواهد شد. به منظور پنهان سازی توالی تصادفی از پاکت های تیره به تعداد نمونه ها استفاده خواهد شد.
    سالمندان دارای معیارهای ورود به روش تخصیص تصادفی بلوکی به دو گروه مداخله و کنترل تخصیص داده خواهند شد برای این منظور از بلوک های شش تایی تولید شده در سایت www.randomizer.org استفاده خواهد شد. به منظور پنهان سازی توالی تصادفی از پاکت های تیره به تعداد نمونه ها استفاده خواهد شد.

  • Recruitment centers

    #1
    Name of recruitment center - English: مراکز خدمات جامع سلامت جنوب تهران وابسته به دانشگاه علوم پزشکی تهران
    Name of recruitment center - Persian: Comprehensive health centres in south of Tehran affiliated to Tehran University of Medical Sciences
    Full name of responsible person - English: Mina Zarrin
    Full name of responsible person - Persian: مینا زرین
    Street address - English: School of Nursing and Midwifery, Tehran University of Medical Sciences, Mirkhani st, Tohid sq, Tehran
    Street address - Persian: میدان توحید، خیابان میرخانی، دانشکده پرستاری و مامایی دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1419733171
    Phone: +98 21 6105 4209
    Fax:
    Email: mi.zarrin97@gmail.com
    Web page address:
    Name of recruitment center - English: Comprehensive health centres in south of Tehran affiliated to Tehran University of Medical Sciences
    Name of recruitment center - Persian: مراکز خدمات جامع سلامت جنوب تهران وابسته به دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Mina Zarrin
    Full name of responsible person - Persian: مینا زرین
    Street address - English: School of Nursing and Midwifery, Tehran University of Medical Sciences, Mirkhani st, Tohid sq, Tehran
    Street address - Persian: میدان توحید، خیابان میرخانی، دانشکده پرستاری و مامایی دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1419733171
    Phone: +98 21 6105 4209
    Fax:
    Email: mi.zarrin97@gmail.com
    Web page address:

Protocol summary

Study aim
Determining the effect of participating in support groups on social frailty and balance confidence among community-dwelling older adults
Design
A randomized clinical trial with two intervention and control groups will be conducted on 132 elderly people who meet the inclusion criteria. Allocation of participants to intervention and control groups will be done by random block allocation method.
Settings and conduct
The place of study will be comprehensive health centres in south of Tehran affiliated to Tehran University of Medical Sciences. The initial sampling will be done by convenience sampling method. Then, 132 elderly people who meet the inclusion criteria will be allocated to two groups of intervention (66 people) and control (66 people) by random block allocation method. blinding will not be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Participants aged 65 to 75, literacy for writing and reading, having informed consent to participate in the study, ability to make eye contact and verbal communication Exclusion criteria: Suffering from cognitive impairment, unwillingness to participate in research, membership in similar groups
Intervention groups
For the intervention group support group sessions will be held 8 times. Each session will last 1 to 1.5 hours in 4 weeks. In these sessions the scenarios based on the components of social frailty and the balance confidence will be presented, then the participants will have group discussion about scenarios. The control group will receive the usual care provided in the health center. َAfter the end of the intervention the content will also be available to the control group.
Main outcome variables
Social frailty, Balance confidence

General information

Reason for update
Considering the interim analysis, the lack of access to a larger sample size, and the limitations of the study, as well as the need to save time and resources, the sample size was reduced to 132 participants after the interim analysis and with the approval of the statistical advisor.
Acronym
IRCT registration information
IRCT registration number: IRCT20240403061405N1
Registration date: 2024-04-29, 1403/02/10
Registration timing: prospective

Last update: 2025-05-19, 1404/02/29
Update count: 1
Registration date
2024-04-29, 1403/02/10
Registrant information
Name
Mina Zarrin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
mi.zarrin97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-08, 1403/03/19
Expected recruitment end date
2024-12-09, 1403/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of participating in support groups on social frailty and balance confidence among community-dwelling older adults
Public title
The effect of participating in support groups on social frailty and balance confidence
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Participants aged 65 to 75 literacy for reading and writing Having Informed consent to participate in the study Ability to make eye contact and verbal communication
Exclusion criteria:
Membership in similar groups Unwillingness to participate in research Suffering from cognitive impairment
Age
From 65 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
Elderly people who meet the inclusion criteria will be allocated to two groups of intervention and control by random block allocation method. for this purpose six blocks produced on www.randomizer.org will be used. In order to hide the random sequence, dark envelopes will be used to the number of samples.
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 Nursing, Midwifery and rehabilitation school of Tehran University of Medical Sci
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Mirkhani st, Tohid sq, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2024-03-17, 1402/12/27
Ethics committee reference number
IR.TUMS.FNM.REC.1402.254

Health conditions studied

1

Description of health condition studied
Social frailty
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Balance confidence
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Social frailty
Timepoint
Before the start of the intervention, straightaway and after 4 weeks from the last intervention session the questionnaires will be completed by the members of the intervention and control groups
Method of measurement
Makizako Social frailty Index

Secondary outcomes

1

Description
Balance Confidence
Timepoint
Before the start of the intervention, straightaway and after 4 weeks from the last intervention session the questionnaires will be completed by the members of the intervention and control groups
Method of measurement
Activities-specific balance confidence Scale

Intervention groups

1

Description
Intervention group: support group sessions will be held 8 times. Each session will last 1 to 1.5 hours in 4 weeks. In these sessions the scenarios based on the components of social frailty ( Going out less frequently than last year, Living alone, Visiting friends sometimes , Feeling like helping friends or family, Talking with someone every day ) and scenarios in relation to the balance confidence will be presented, then the participants will have group discussion about scenarios.
Category
Other

2

Description
Control group: This group will receive the usual care provided in the health center and no intervention will be performed
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive health centres in south of Tehran affiliated to Tehran University of Medical Sciences
Full name of responsible person
Mina Zarrin
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Mirkhani st, Tohid sq, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4209
Email
mi.zarrin97@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari sari
Street address
Sixth floor, Central office of Tehran University of Medical Sciences, Qods st, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3685
Email
info@tums.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mina Zarrin
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Mirkhani st, Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4209
Email
mi.zarrin97@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Zarrin
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Mirkhani st, Tohid sq, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4209
Fax
Email
mi.zarrin97@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Zarrin
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Mirkhani st, Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4209
Email
mi.zarrin97@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The participants' information will be kept confidential and can be made available by contacting the corresponding author with a justified reason
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers who work in academic and scientific institutions
Under which criteria data/document could be used
The data obtained from the study will be kept confidential and will be available to the corresponding author. If there is a need to access the data, it can be made available by contacting the corresponding author with a justified reason.
From where data/document is obtainable
Dr Sarieh Poortaghi s-poortaghi@tums.ac.ir School of Nursing and midwifery, Tehran University of Medical sciences
What processes are involved for a request to access data/document
The applicant will receive the information required after sending the request via email
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