Protocol summary
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Study aim
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Determining the effect of participating in support groups on social frailty and balance confidence among community-dwelling older adults
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Social frailty, Balance confidence
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2024-04-29, 1403/02/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-06-08, 1403/03/19
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Expected recruitment end date
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2024-12-09, 1403/09/19
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The effect of participating in support groups on social frailty and balance confidence
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 65 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
132
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-03-17, 1402/12/27
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Ethics committee reference number
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IR.TUMS.FNM.REC.1402.254
Health conditions studied
1
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Description of health condition studied
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Social frailty
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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Balance confidence
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Social frailty
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Timepoint
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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
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Method of measurement
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Makizako Social frailty Index
Secondary outcomes
1
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Description
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Balance Confidence
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Timepoint
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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
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Method of measurement
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Activities-specific balance confidence Scale
Intervention groups
1
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Description
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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.
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Category
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Other
2
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Description
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Control group: This group will receive the usual care provided in the health center and no intervention will be performed
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The participants' information will be kept confidential and can be made available by contacting the corresponding author with a justified reason
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When the data will become available and for how long
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6 months after the results are published
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To whom data/document is available
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Researchers who work in academic and scientific institutions
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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Dr Sarieh Poortaghi
s-poortaghi@tums.ac.ir
School of Nursing and midwifery, Tehran University of Medical sciences
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What processes are involved for a request to access data/document
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The applicant will receive the information required after sending the request via email
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Comments
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