Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT05315960
Status:
UNKNOWN
Last Update Posted:
2023-11-30
First Post:
2022-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SOcial coNNEction in Long-Term Care Home Residents
Sponsor:
University College, London
Organization:
Study Overview
Official Title:
SOcial coNNEction in Long-Term Care Home Residents
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SONNET
Brief Summary:
This study aims to develop a new measure which can accurately assess social connection for people with dementia living in long-term care homes. The Social Connection in Long-term Care home residents (SONNET) study will use interviews and focus groups with people affected by dementia and long-term care residents to establish what aspects of social connection are important for people living in care homes. These findings and a review of other studies and measures will be used to develop a new measure or measures of social connection which will then be tested in a study based in care homes in Canada and the UK.
Detailed Description:
Research Question:
Can a new measure reliably and validly assess social connection for people with dementia in care homes?
Background:
Social connection, including objective and subjective constructs relating to human relationships, is a fundamental human need, but is impaired in people with dementia, particularly in those living in long-term care (LTC) settings due to cognitive impairment, complex health needs, and separation from previous social networks and community activities. Measurement instruments therefore need to be tailored to the distinct characteristics of this population and be tested in this setting, but there is no current evidence-based consensus on the best approaches to measurement.
Objectives:
1. Appraise existing measures of social connection used in LTC homes
2. Evaluate which aspects of social connection are considered important by people affected by dementia and professional staff
3. Develop a new measure informed by our appraisal of previous measures and the priorities of key stakeholders and test its preliminary psychometric properties
Methods:
A systematic review of measurement instruments assessing social connection in LTC residents, including dementia-specific measures will be conducted and measures will be appraised using COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) methodology. Focus groups and qualitative interviews will then be conducted with 50-70 people living with dementia, LTC residents, families, clinicians, care staff, and researchers in the UK and Canada to establish the important aspects of social connection and its measurement, including considerations for LTC residents with dementia and those with different stages of dementia severity. Findings from the systematic review and qualitative study will be used to inform the development of a measure or measures which will be iteratively refined during interviews. Finally, the new measure(s) will be tested for psychometric properties in 150 people with dementia living in LTC homes in the UK and Canada to establish acceptability, reliability, and validity.
Can a new measure reliably and validly assess social connection for people with dementia in care homes?
Background:
Social connection, including objective and subjective constructs relating to human relationships, is a fundamental human need, but is impaired in people with dementia, particularly in those living in long-term care (LTC) settings due to cognitive impairment, complex health needs, and separation from previous social networks and community activities. Measurement instruments therefore need to be tailored to the distinct characteristics of this population and be tested in this setting, but there is no current evidence-based consensus on the best approaches to measurement.
Objectives:
1. Appraise existing measures of social connection used in LTC homes
2. Evaluate which aspects of social connection are considered important by people affected by dementia and professional staff
3. Develop a new measure informed by our appraisal of previous measures and the priorities of key stakeholders and test its preliminary psychometric properties
Methods:
A systematic review of measurement instruments assessing social connection in LTC residents, including dementia-specific measures will be conducted and measures will be appraised using COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) methodology. Focus groups and qualitative interviews will then be conducted with 50-70 people living with dementia, LTC residents, families, clinicians, care staff, and researchers in the UK and Canada to establish the important aspects of social connection and its measurement, including considerations for LTC residents with dementia and those with different stages of dementia severity. Findings from the systematic review and qualitative study will be used to inform the development of a measure or measures which will be iteratively refined during interviews. Finally, the new measure(s) will be tested for psychometric properties in 150 people with dementia living in LTC homes in the UK and Canada to establish acceptability, reliability, and validity.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: