DementiaSONNETNCT05315960
SOcial coNNEction in Long-Term Care Home Residents
An observational study of Dementia, run by University College, London at 2 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- How many people
- 220 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 May 2022to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
Jennifer Bethell contact
2 sites in 2 countries
Canada1 site, 1 recruiting
- Not yet recruiting
University Health Network
Toronto, Ontario, M5G 2A2
Jennifer Bethell, jennifer.bethell@uhn.ca
United Kingdom1 site, 1 recruiting
- Recruiting
Division of Psychiatry, University College London
London, W1T 7NF
Andrew Sommerlad, a.sommerlad@ucl.ac.uk
About this study
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.
Read the 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:
- Appraise existing measures of social connection used in LTC homes
- Evaluate which aspects of social connection are considered important by people affected by dementia and professional staff
- 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.
- Conditions
- Dementia
- Keywords
- Dementia, Long-term care, Outcome measurement, PROM, Psychometric
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Secondary outcomes (5)
Clinical Dementia Rating Scale
Minimum 0, Maximum 5. Higher scores indicate a more severe dementia.
Measured: 10 minutes
Neuropsychiatric Inventory
Minimum 0, Maximum 144. Higher scores indicate a more severe neuropsychiatric symptoms.
Measured: 10 minutes
Katz Index of Independence in activities of Daily Living
Minimum 0, Maximum 6. Higher scores indicate more independence in activities in daily living.
Measured: 10 minutes
Dementia-specific quality of life (DEMQOL-Proxy)
Minimum 31, Maximum 124. Higher scores indicate better health-related quality of life.
Measured: 10 minutes
Family caregiver proxy-raters only will also be asked to completed the EQ5D
Minimum 0, Maximum 1. Higher scores indicate better quality of life.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start16 May 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315960
- Sponsor's protocol ID
- 146256
- Acronym
- SONNET
- Status last verified
- Nov 2023
- First submitted
- 18 Mar 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39438797
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOcial coNNEction in Long-Term Care Home Residents
- ClinicalTrials.gov ID
- NCT05315960
- Acronym / sponsor ID
- SONNET / 146256
- Conditions
- Dementia
- Keywords
- Dementia, Long-term care, Outcome measurement, PROM, Psychometric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 16 May 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Appraise existing measures of social connection used in LTC homes
- Evaluate which aspects of social connection are considered important by people affected by dementia and professional staff
- 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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Clinical Dementia Rating Scale
Time frame: 10 minutes
Neuropsychiatric Inventory
Time frame: 10 minutes
Katz Index of Independence in activities of Daily Living
Time frame: 10 minutes
Dementia-specific quality of life (DEMQOL-Proxy)
Time frame: 10 minutes
Family caregiver proxy-raters only will also be asked to completed the EQ5D
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Derived from this study: PubMed 39438797Chapman 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.
- Individual participant dataSharing planned: Undecided
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Bethell contact
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by University College, London at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Sommerlad (+442076799248, a.sommerlad@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resident Assessment Instrument-Minimum Data Set (RAI-MDS) Index of Social Engagement (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05315960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.