SOcial coNNEction in Long-Term Care Home Residents (SONNET)

November 29, 2023 updated by: University College, London
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will purposively sample participants for diverse representation, including with respect to age, sex, gender identity, sexual orientation, socioeconomic status, race, ethnicity, and, marital status. To ensure a range of demographic characteristics and to include traditionally under-represented groups, English language proficiency for people living with dementia, LTC residents and caregivers (e.g. family, friend) is not a requirement. Interpreters will be used for those not fluent in English and arranged through the institution's interpreter services.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resident Assessment Instrument-Minimum Data Set (RAI-MDS) Index of Social Engagement
Time Frame: 10 minutes
Minimum 0, Maximum 6. Higher scores indicate a higher level of social engagement.
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Dementia Rating Scale
Time Frame: 10 minutes
Minimum 0, Maximum 5. Higher scores indicate a more severe dementia.
10 minutes
Neuropsychiatric Inventory
Time Frame: 10 minutes
Minimum 0, Maximum 144. Higher scores indicate a more severe neuropsychiatric symptoms.
10 minutes
Katz Index of Independence in activities of Daily Living
Time Frame: 10 minutes
Minimum 0, Maximum 6. Higher scores indicate more independence in activities in daily living.
10 minutes
Dementia-specific quality of life (DEMQOL-Proxy)
Time Frame: 10 minutes
Minimum 31, Maximum 124. Higher scores indicate better health-related quality of life.
10 minutes
Family caregiver proxy-raters only will also be asked to completed the EQ5D
Time Frame: 5 minutes
Minimum 0, Maximum 1. Higher scores indicate better quality of life.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2022

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 146256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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