SONNET: SOcial coNNEction in Long-Term Care Home Residents

Sponsor
University College, London (Other)
Overall Status
Recruiting
CT.gov ID
NCT05315960
Collaborator
University Health Network, Toronto (Other)
220
2
21.5
110
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    220 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    SOcial coNNEction in Long-Term Care Home Residents
    Actual Study Start Date :
    May 16, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Feb 29, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Qualitative study

    Consenting participants will complete a form asking about basic characteristics including age, sex, ethnicity, marital status etc. People living in long-term care and family carers will participate in an individual interview and professional staff will participate in an individual interview or focus group (between 5 and 10 participants) depending on their preference. The interview or focus group is expected to last 30-60 minutes. Sessions will be conducted in-person or online (using MS Teams), depending on preference and COVID-19-related restrictions. All sessions will be audio-recorded and transcribed.

    Cross-sectional study

    Procedures: Consent will be obtained from residents, for those who have mental capacity to give informed consent, or from a nearest relative or caregiver as consultee, for those who lack capacity. Once consent is obtained, the LTC resident will be asked to complete a form asking about their characteristics and a questionnaire about their social connections which is expected to take approximately 15 minutes. The proxy will be asked to complete a sociodemographic form about themselves along with a number of questionnaires regarding the LTC resident's dementia severity, neuropsychiatric symptoms, activities of daily living and quality of life for comparison. Data collection for the proxy is expected to take approximately 30-60 minutes. Anticipated sample size 150 between Canada and the UK.

    Outcome Measures

    Primary Outcome Measures

    1. Resident Assessment Instrument-Minimum Data Set (RAI-MDS) Index of Social Engagement [10 minutes]

      Minimum 0, Maximum 6. Higher scores indicate a higher level of social engagement.

    Secondary Outcome Measures

    1. Clinical Dementia Rating Scale [10 minutes]

      Minimum 0, Maximum 5. Higher scores indicate a more severe dementia.

    2. Neuropsychiatric Inventory [10 minutes]

      Minimum 0, Maximum 144. Higher scores indicate a more severe neuropsychiatric symptoms.

    3. Katz Index of Independence in activities of Daily Living [10 minutes]

      Minimum 0, Maximum 6. Higher scores indicate more independence in activities in daily living.

    4. Dementia-specific quality of life (DEMQOL-Proxy) [10 minutes]

      Minimum 31, Maximum 124. Higher scores indicate better health-related quality of life.

    5. Family caregiver proxy-raters only will also be asked to completed the EQ5D [5 minutes]

      Minimum 0, Maximum 1. Higher scores indicate better quality of life.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 110 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health Network Toronto Ontario Canada M5G 2A2
    2 Division of Psychiatry, University College London London United Kingdom W1T 7NF

    Sponsors and Collaborators

    • University College, London
    • University Health Network, Toronto

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University College, London
    ClinicalTrials.gov Identifier:
    NCT05315960
    Other Study ID Numbers:
    • 146256
    First Posted:
    Apr 7, 2022
    Last Update Posted:
    May 23, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University College, London
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 23, 2022