Connecting Today to Combat Social Isolation and Loneliness

University of Alberta

Status: Not yet enrolling

Conditions: Remote Visits; Family; Dementia in Nursing Home

Treatments: Behavioral: Connecting Today

Study type: Interventional

Funder types: Other

Identifiers

NCT07182019

Pro00152323

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention group will receive the Connecting Today intervention for 6 weeks following T0 (i.e. the first outcome data collection period).

Treatment:

Behavioral: Connecting Today

Control

No Intervention group

Description:

The control group will not receive the Connecting Today intervention after T0. They are a waitlist control, so will receive the Connecting Today intervention after T1 (i.e. after the second outcome data collection period). Data collection for outcome variables will be the same as participants in the intervention group. The only difference between groups is timing of the intervention.