Connecting Today to Combat Social Isolation and Loneliness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Connecting Today.
- Who it may be relevant to
- Registry conditions: Dementia in Nursing Home, Family, Remote Visits. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Connecting Today to Combat Social Isolation and Loneliness: An Evaluation of a Remote Visiting Program for Care Home Residents Living With Dementia
Overview
The investigators developed Connecting Today, a feasible and highly acceptable remote visiting program that can support care home residents living with moderate to severe dementia to have video calls with their family members, friends, or care partners. The investigators will recruit 80 residents from 4 care homes, and their family members, friends, or care partners. All participants will be offered 60 minutes of Connecting Today per week for 6 weeks (in either the intervention group, or in the wait-list control group). An onsite care provider will be trained to tailor the video calls, and facilitate positive verbal and non-verbal engagement during the calls. The investigators will evaluate how Connecting Today affects outcomes for residents (quality of life, loneliness, and responsive behaviours) and their remote visitors (quality of life, loneliness, and social support). The investigators will assess how outcomes differ for men, women, and people with different perceptions and experiences of Connecting Today.
Detailed description
Justification For decades, care home residents living with dementia have suffered disproportionately from social isolation (being alone), loneliness (feeling alone), and poor quality of life. Paradoxically, they have also been excluded from intervention research to address these pernicious problems. The investigators developed Connecting Today, a facilitated remote visiting program, to engage care home residents with dementia in positive interactions with their family members, friends, and care partners. Scoping reviews, a mixed methods study, and pilot/ feasibility studies in Alberta support feasibility and high acceptability of Connecting Today.
Purpose This study will evaluate the feasibility of a multi-province RCT of Connecting Today in preparation for a full effectiveness trial.
Objectives
1. Assess feasibility of a pragmatic randomized wait-list control trial of Connecting Today, a remote visiting program, when used in care homes in Alberta, Saskatchewan and Ontario. 2. Examine Connecting Today's hypothesized mechanisms of action within intervention and wait-list control groups.
Research Method/Procedures The investigators will recruit 80 residents living with dementia from 4 total care homes (one each in Alberta, Saskatchewan, and two in Ontario) and their family members, friends, or care partners (1 to 3 for each resident). Participants will receive 6 weeks of Connecting Today: facilitated video calls (up to 60 min weekly). Residents' designated decision-makers will provide consent for resident participation. Research assistants (blinded to assignment status) will collect reliable and valid outcome measures in telephone interviews for residents (via proxy report) and remote visitors (via self-report). Outcomes are measured for all participants at: T0=baseline (weeks 1-2), T1=after 6 weeks of intervention delivery to the treatment group (weeks 9-10), and T2=after 6 weeks of intervention delivery to the control group (weeks 17-18).
The difference between the control group and intervention group is timing of intervention delivery. The intervention group will receive the intervention in weeks 3-8 (i.e. between T0 and T1) and the control group will receive the intervention in weeks 11-16 (i.e. between T1 and T2).
Plan for Data Analysis To address aim 1 (feasibility), the investigators will complete a quantitative assessment of trial and intervention processes including rates of recruitment, retention, attrition, fidelity of intervention delivery, and missing data (compared to pre-specified thresholds), assignment beliefs, treatment experiences and perceptions, and features of usual care.
To address aim 2 (mechanisms of action), the investigators will use generalized estimating equations and a single group before-after design combining intervention and wait-list control groups to complete a within-group outcomes analysis, adjusted for care home cluster and with gender and intervention processes included as covariates/moderators.
Interventions
- Behavioral Connecting Today
Connecting today is a facilitated remote visiting program for people living with moderate to severe dementia in care homes. The program offers residents up to 60 minutes of scheduled contact with a family member, friend or volunteer by video call. An onsite facilitator supports the video calls which are delivered via ipad/zoom.
Primary outcome measures
- Change in the Dementia Quality of Life Instrument (DEMQOL- proxy) total score. [Time frame: Baseline (T0), after 6 weeks of intervention delivery to the treatment group (T1), and after 6 weeks of intervention delivery to the control group (T2).]
- Change in the Dementia Quality of Life - Care Home Instrument (DEMQOL- CH) total score. [Time frame: Baseline (T0), after 6 weeks of intervention delivery to the treatment group (T1), and after 6 weeks of intervention delivery to the control group (T2).]
- Change in the the Quality of Life - Aged Care Consumers (QOL-ACC- proxy) total score. [Time frame: Baseline (T0), after 6 weeks of intervention delivery to the treatment group (T1), and after 6 weeks of intervention delivery to the control group (T2).]
Secondary outcome measures (11)
- Change in single item from the Dementia Quality of Life Instrument (DEMQOL- proxy) [Time frame: Baseline (T0), after 6 weeks of intervention delivery to the treatment group (T1), and after 6 weeks of intervention delivery to the control group (T2).]
- Change in a single item from the Dementia Quality of Life - Care Home Instrument (DEMQOL- CH) [Time frame: Baseline (T0), after 6 weeks of intervention delivery to the treatment group (T1), and after 6 weeks of intervention delivery to the control group (T2).]
- Change in three items from the Dementia Quality of Life Instrument (DEMQOL- proxy) [Time frame: Baseline (T0), after 6 weeks of intervention delivery to the treatment group (T1), and after 6 weeks of intervention delivery to the control group (T2).]
- Change in three items from the Dementia Quality of Life - Care Home Instrument (DEMQOL- CH) [Time frame: Baseline (T0), after 6 weeks of intervention delivery to the treatment group (T1), and after 6 weeks of intervention delivery to the control group (T2).]
- Change in the Social Connection In Long-Term Care Home Residents (SONNET) Scale-proxy [Time frame: Baseline (T0), after 6 weeks of intervention delivery to the treatment group (T1), and after 6 weeks of intervention delivery to the control group (T2).]
- Change in the Cohen-Mansfield Agitation Inventory - short form [Time frame: Baseline (T0), after 6 weeks of intervention delivery to the treatment group (T1), and after 6 weeks of intervention delivery to the control group (T2).]
- Change in the 3-item Loneliness Scale total score [Time frame: Baseline (T0), after 6 weeks of intervention delivery to the treatment group (T1), and after 6 weeks of intervention delivery to the control group (T2).]
- Change in the Multidimensional Scale of Perceived Social Support (MSPSS) total score [Time frame: Baseline (T0), after 6 weeks of intervention delivery to the treatment group (T1), and after 6 weeks of intervention delivery to the control group (T2).]
- Change in the Quality of Life Scale (QOLS) [Time frame: Baseline (T0), after 6 weeks of intervention delivery to the treatment group (T1), and after 6 weeks of intervention delivery to the control group (T2).]
- Change in the Satisfaction with Life Scale (SWLS) [Time frame: Baseline (T0), after 6 weeks of intervention delivery to the treatment group (T1), and after 6 weeks of intervention delivery to the control group (T2).]
- Change in a single item from the World Health Organization Quality of Life (WHOQOL- BREF) [Time frame: Baseline (T0), after 6 weeks of intervention delivery to the treatment group (T1), and after 6 weeks of intervention delivery to the control group (T2).]
Eligibility criteria
Inclusion criteria
Residents:
- are at least 65 years old
- are diagnosed with any type of dementia
- have a Cognitive Performance Score (CPS) indicating moderate to severe impairment (CPS 3-6).
- to participate, residents must also have people that self identify as a family member or friend of the person with dementia.
Remote visitors:
- are people that self-identify as a family member or friend of the person with dementia
- are people with whom the person with dementia desires contact
- are 18 or older
- understand and speak English.
Exclusion criteria
- All remote visitors are required to understand and speak English as this is necessary for the facilitator to support the call and for data to be collected.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Canada · 1 center
- University of Alberta — Edmonton
Identifiers
NCT: NCT07182019 · Pro00152323