NCT05315960

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 16, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

March 18, 2022

Last Update Submit

November 29, 2023

Conditions

Keywords

DementiaLong-term careOutcome measurementPROMPsychometric

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Clinical Dementia Rating Scale

    10 minutes

  • Neuropsychiatric Inventory

    10 minutes

  • Katz Index of Independence in activities of Daily Living

    10 minutes

  • Dementia-specific quality of life (DEMQOL-Proxy)

    10 minutes

  • Family caregiver proxy-raters only will also be asked to completed the EQ5D

    5 minutes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Health Network

Toronto, Ontario, M5G 2A2, Canada

NOT YET RECRUITING

Division of Psychiatry, University College London

London, W1T 7NF, United Kingdom

RECRUITING

Related Publications (1)

  • Chapman H, Bethell J, Dewan N, Liougas MP, Livingston G, McGilton KS, Sommerlad A. Social connection in long-term care homes: a qualitative study of barriers and facilitators. BMC Geriatr. 2024 Oct 22;24(1):857. doi: 10.1186/s12877-024-05454-8.

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Andrew Sommerlad

CONTACT

Jennifer Bethell

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2022

First Posted

April 7, 2022

Study Start

May 16, 2022

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

November 30, 2023

Record last verified: 2023-11

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