SOcial coNNEction in Long-Term Care Home Residents

Dementia Clinical Trial

— SONNET  

Official title:

SOcial coNNEction in Long-Term Care Home Residents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05315960
• Other study ID #: 146256
• Status: Recruiting
• Start date: May 16, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2023
• Source: University College, London
• Contact: Andrew Sommerlad
• Phone: +442076799248
• Email: a.sommerlad[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Qualitative study

Inclusion criteria:

• LTC residents with or without dementia: Able to provide consent for research.

• Caregivers: Visit the resident at least monthly (not including when COVID-related visitor restrictions are in place).

• Clinicians/care staff: Whose role currently includes working in LTC home or has done in past 2 years.

• Academic researchers: Have expertise in social functioning in dementia.

• All participants must be over the age of 18 years old to participate in the study.

Cross-sectional study Inclusion criteria

• LTC residents: Have a confirmed diagnosis of dementia OR Scoring =2 on the Noticeable Problems Checklist

• Proxy: Visit or care for the resident at least once monthly.

• All participants must be over the age of 18 years old and have adequate English language proficiency to participate in the study.

Related Conditions & MeSH terms

• Dementia

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario
United Kingdom	Division of Psychiatry, University College London	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	University Health Network, Toronto

Countries where clinical trial is conducted

Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resident Assessment Instrument-Minimum Data Set (RAI-MDS) Index of Social Engagement	Minimum 0, Maximum 6. Higher scores indicate a higher level of social engagement.	10 minutes
Secondary	Clinical Dementia Rating Scale	Minimum 0, Maximum 5. Higher scores indicate a more severe dementia.	10 minutes
Secondary	Neuropsychiatric Inventory	Minimum 0, Maximum 144. Higher scores indicate a more severe neuropsychiatric symptoms.	10 minutes
Secondary	Katz Index of Independence in activities of Daily Living	Minimum 0, Maximum 6. Higher scores indicate more independence in activities in daily living.	10 minutes
Secondary	Dementia-specific quality of life (DEMQOL-Proxy)	Minimum 31, Maximum 124. Higher scores indicate better health-related quality of life.	10 minutes
Secondary	Family caregiver proxy-raters only will also be asked to completed the EQ5D	Minimum 0, Maximum 1. Higher scores indicate better quality of life.	5 minutes