Impact of a peer-support programme to improve loneliness and social isolation due to COVID-19: does adding a secure, user friendly video-conference solution work better than telephone support alone? Protocol for a three-arm randomised clinical trial

Introduction

Lack of contact with others (social isolation) and dissatisfaction with the quantity or quality of social interactions (loneliness1–3) are two highly correlated concepts. Together they are strongly associated with reduced quality of life,4 increased risk of dementia5 and disability,6 and many other adverse outcomes.3 7–18 Most worrisome is that social isolation and loneliness increase risk of mortality as much as smoking7 13 17 and are estimated to contribute to 45 000 additional deaths per year in Canada.19 Social isolation and loneliness are estimated to cost £2.5 billion/year in the UK, and in 2017 in the UK, the equivalent of £20 million was spent to combat social isolation. Social isolation interventions are estimated to save £2–3 per GBP invested.20 21

The COVID-19 pandemic has forced physical distancing and isolation strategies worldwide.21–25 During the 2003 SARS outbreak, older adults in Hong Kong were the most severely impacted by social isolation22—their suicide rates increased by 25% after having declined over the previous 12 years.23 Baseline loneliness among older patients has increased from 40% to 70%.24 Given variable vaccine uptake, the appearance of variants of concern, and their increased vulnerability, older people will be more reluctant to engage socially even after mandatory COVID-19-associated restrictions are loosened.25–27 For many older people living alone a medical visit provides an opportunity to connect with others. Due to social distancing measures during the lock down the imposed social isolation on older people may accelerate disease progression of their existing conditions and increase their risk of cognitive impairment.28

A significant challenge to research on social isolation and loneliness is the inherent difficulty recruiting socially isolated people from the community, with recruitment rates of less than 15% reported.29–32 Yet, studies in multiple settings have shown that lonely people are more likely to use healthcare.33–37 Studies recruiting from the emergency department (ED) and clinical settings with a high concentration of older isolated people are lacking.33–37

Thus, we set out to find an intervention that targets older patients and could be delivered remotely during COVID-19 associated restrictions,.1 17 38 39 We selected the HOspitals WoRking in Unity (‘HOW R U?’) intervention (HOspitals WoRking in Unison with patients (see online supplemental Appendix 1 for detailed description of rational). Lowthian et al previously demonstrated the feasibility and safety of using lay volunteers to deliver a telephone-based weekly intervention for 12 weeks.40 41 Given increasing evidence that videoconferencing may be preferred by older people,42–45 we also set to test the effective adding a secure, user friendly video-conferencing platform (‘aTouchAway’) to deliver the ‘HOW R U?’ intervention.

Supplemental material

Objectives and hypotheses

Our study design will allow us to test multiple hypotheses simultaneously.

Primary objective

Our principal research question is whether the use of the HOW RU intervention delivered by telephone is more effective than the waiting list control group in reducing loneliness measured with the De Jong six items scale. We will also simultaneously assess whether HOW RU in combination with the ‘aTouchAway’ video platform is more effective in reducing loneliness compared with the common waiting list control group.

Hypotheses 1

We hypothesise that the ‘HOW RU?’ peer-support intervention delivered by telephone will significantly reduce social isolation and loneliness compared with the control group.

Hypotheses 2

We hypothesise that use of the ‘aTouchAway’ e-Health platform combined with the evidence-based ‘HOW RU?’ peer-support intervention will significantly reduce social isolation and loneliness compared with the control group.

Hypotheses 3

We hypothesise that use of the ‘aTouchAway’ e-Health platform combined with the ‘HOW RU?’ peer-support intervention will significantly reduce social isolation and loneliness compared with ‘HOW RU?’ delivered by telephone alone.

Secondary objective 1

We will also assess the impact of COVID-19 on social isolation and loneliness in older people who access healthcare.

Hypotheses 4: Older people will have increased social isolation and loneliness during COVID-19 restrictions compared with before COVI-19 restrictions.

Secondary objectives 2–6

We will assess the impact of the ‘HOW RU?’ intervention delivered by telephone alone on (2) social isolation (Lubben’s Social Network Scale); (3) mood (Geriatric Depression Scale); (4) quality of life; (5) functional status and (6) all-cause mortality compared with the standard care group. Please see the ‘Outcome measures’ section for details. Cognitive function will be measured at baseline as a potential confounding variable.

Hypothesis 5: We hypothesise that the ‘HOW RU?’ intervention will improve social isolation and mood, and quality of life, but will not impact functional status or all-cause mortality.

Hypothesis 6: We hypothesise that the ‘HOW RU?’ intervention delivered by video teleconference will improve social isolation, mood and quality of life, but will not impact cognitive impairment, functional status or all-cause mortality.

Secondary objective 7

We will assess the sustainability of the impacts of both versions of the HOW R U? interventions on primary and secondary outcomes at 24 weeks after termination of the intervention.

Secondary objective 8

We will assess feasibility and process outcomes to help us interpret the study results including: (8.1) assessing the frequency and duration of peer-volunteer interactions with participants to assess intervention fidelity; (8.2) measuring participant preferences regarding delivery of HOW R U? by telephone or via a secure video-conferencing solution. (8.3) We will assess the rate of participant completion of both video and telephone versions of the intervention, as well as the reasons for withdrawal, including technological, physical and mental health issues. (8.4) We will assess the rate of volunteer completion of both video and telephone versions of the intervention, as well as the reasons for withdrawal, including technological, physical and mental health issues. Feasibility measures will be used to guide future sample size calculations and resource requests, and no arbitrary threshold for feasibility will be set a priori.

Methods and analysis

Patient and public involvement

Original development of the ‘HOW R U?’ intervention was informed by patients participating in the Safe Elderly Emergency Discharge project which mapped the demographic, clinical, functional and psychosocial profiles of a large cohort (n=959) of older ED patients.46 47 In addition, adaptation of the current study protocol was informed by consultation with volunteer services as well as the patient and family advocacy committees at both Mount Sinai and Bridgepoint hospitals, Toronto, Canada.

Study design and setting

This multicentred, three-arm, outcome assessor blinded randomised clinical trial will follow Consolidated Standard of Reporting Trials reporting guidelines and is part of a programme of research that adheres to the Obesity-Related Behavioural Intervention Trial model for developing complex behavioural interventions.48 49 In this model, the previous study by Lowthian et al established the proof of concept, and the current trial phase IIb is adequately powered to test whether two versions of the ‘HOW R U?’ intervention are effective compared with a common standard care arm.46 47

Patients will be recruited from two hospitals including the Schwartz/Reisman Emergency Medicine centre at Mount Sinai Hospital, and the North York General Hospital in Toronto, Ontario, Canada. Mount Sinai is an urban, tertiary care centre that sees 65 000 ED patients per year, and North York General is a university-affiliated academic community hospital that sees 118 000 ED patients per year. Referrals will also be accepted from geriatrics, geriatric psychiatry and family medicine clinics at the two participating centres (see the ‘Recruitment’ section).

Inclusion and exclusion criteria

Any person 70 years of age and older receiving care at participating EDs and clinics will be eligible. We will exclude individuals with communication problems including those who are critically ill, unconscious, unable to communicate in English, speech impairment or otherwise unable to provide consent and those admitted to hospital for >72 hours. Patients with significant cognitive impairment such that they are dependent on others for their activities of daily living will also be excluded. All potential participants will be screened for loneliness using the de Jong loneliness scale (see the ‘Outcome’ section).50 51 Those with low risk for baseline loneliness (<2 on the de Jong scale) will be excluded. Finally, patients without any mobile phone or landline will be excluded. Data show that even among the lowest income quartile, 98.2% of Canadians have a telephone.52 Volunteers will be 60 years of age or older to qualify as peer supporters.

Recruitment

Research staff have access to the ED information systems and permission to contact all eligible ED patients by telephone the next day (see the ‘Ethics’ section). Because of the known difficulties recruiting isolated and lonely people, we will also accept referrals from other care providers with a higher likelihood of seeing socially isolated or lonely older people, that is, the Geriatrics and Geriatric Psychiatry clinics and the Granovsky-Gluskin Family Medical Centre at Mount Sinai hospital.29–31

All potential eligible participants will be contacted by a research assistant (RA) by telephone the next business day and will undergo baseline screening for eligibility, including baseline assessment of the de Jong loneliness scale. Access to information systems in the ED and participating clinics will allow research staff to innumerate all eligible participants and the number who decline, are missed, or are otherwise ineligible. All aspects of data collection and the intervention can be conducted without face-to-face contact in the face of fluctuating and unpredictable COVID-19 physical distancing orders.

Recruitment, training and safety protocol for peer-support volunteers

In partnership with volunteer services at Mount Sinai hospital, volunteers will be recruited from existing hospital volunteers, many of whom had to discontinue their in-hospital duties during COVID-19. We will recruit similar aged peer volunteers (≥60 years of age), and their training will emphasise confidentiality, risk management, peer support, empathetic listening and provision of available community resources. Two core theoretical frameworks on which ‘HOW RU?’ is based include (1) the strength-based approach whereby interactions with volunteers are focused on empowerment and the participant’s strengths and resources rather than their limitations, problems and pathologies and (2) peer support whereby lay-people with similar life experience are paired with participants.53–55 Thus volunteers will have no professional training—this will also improve the feasibility of recruiting volunteers.

This approach was successfully taught to volunteers in a half-day session in previous studies.41 53 Since the publication of the ‘HOW R U?’ intervention, Lowthian et al implemented the programme in response to COVID-19, and modified their training to be available online. Thus, all training modules for the current IIb trial will be transcribed from these updated training modules developed by the Bolton Clarke Research Institute.40 41 Specifically, language will be modified to Canadian usage, and resources available in the Greater Toronto area will be included.

As participants may be experiencing mental health challenges including suicidality, we will train all staff and volunteers to use a safety protocol that we have used in our research programme for over a decade. If research staff or volunteers have any safety concerns for the physical or mental health of participants, they will escalate this concern to a study physician (JSL and SK) who will be available to assess concerns. Using this safety protocol, the principal investigator has had to intervene once in 10 years for a client who suffered a syncopal episode during a telephone interview.

Randomisation and blinding

The study statistician (AK) will use a computerised random number generator to create three block randomisation lists stratified by source of referrals. Thus, we will have an equal distribution of participants from each of the four referral sources (MSH ED, MSH Geriatric Clinic, MSH Geriatric Psychiatry and NYGH ED). It is not feasible to blind participants to the intervention; however, outcome assessors will be blinded. The research coordinator will match volunteers and participants based on any gender preferences of the participant and any shared interests prior to revealing study arm allocation. Primary outcomes will be assessed after 12 weeks by an RA who has had no previous contact with participants and is blinded to the group allocation. The outcome assessor will be trained on how to objectively score the primary outcome, and to keep the primary outcome assessment interview short to minimise the risk of unblinding. Finally, the outcome assessor will record any instances of unblinding.

Intervention

We will compare: (1) ‘HOW R U?’ intervention delivered by telephone; (2) ‘HOW R U?’ intervention combined with a video-conferencing solution and (3) a common control group receiving standard care. Please see figure 1 for an overview of proposed methods.

Figure 1
Figure 1

Overview of proposed study design. HOW R U, HOspitals WoRking in Unity; SIL, Soical Isolation and Loneliness.

Intervention group 1

Group 1 will receive the ‘HOW R U?’ intervention over the telephone. We have attempted to replicate the intervention as it was delivered in the previous trial.47 56 ‘HOW R U?’ trained volunteer-peers provide strength-based support sessions weekly over the phone for 12 weeks. While there are no formal scripts, and interactions typically are described as conversational, during each telephone support session, peer-support volunteers are trained to establish trust and rapport, listen empathically, set goals to improve social isolation, loneliness and well-being for the week, and review progress over the prior week. We will aim for one 20–30 min telephone call per week over 12 weeks. Volunteer peers will log interactions and goals established in order to assess intervention fidelity.

Intervention group 2

Group 2 will receive the ‘HOW R U?’ intervention as described above. The difference is that it will be delivered over the ‘aTouchAway’ secure e-platform enabling video-connection rather than by telephone. ‘aTouchAway’ will log only the time and duration of interactions. This deidentified meta-data will be stored in the AWS Canadian cloud; no recordings will be stored to protect participant privacy. To reduce selection bias based on their technological capabilities, all participants randomised to use ‘aTouchAway’ will be provided with a preloaded locked, cellular enabled tablet for the duration of the study. ‘aTouchAway’ was designed for simplicity and has been deployed in multiple organisations in Canada, USA and the UK for a variety of use cases including as a virtual visiting solution in 180 NHS hospitals.57 It is also currently being used as a COVID-19 response for individuals living at home on mechanical ventilation in eight centres in Ontario, Canada.57 58 Tablets will be delivered by a ‘touchless’ courier service. Similarly, a courier will retrieve tablets after the 12-week intervention.

Standard care

Patients randomised to the standard care group will be offered the current standard of care during the 12-week waiting period. Specifically, social isolation and loneliness are not routinely measured nor treated at the participating sites. Both control and intervention participants otherwise received their standard care without restrictions.

Data collection

All data collection will be conducted over the telephone. Research staff will screen potentially eligible participants using the six-item de Jong Gierveld loneliness scale (see outcome measure for primary outcome below). Eligible patients will then have demographic data recorded, as well as baseline assessments of the primary and secondary outcome measures (see see outcome measures below). No study endpoints will be collected during administration of the 12-week intervention period to minimise potential Hawthorne effect. Outcome measures will be reassessed within 2 weeks of completion of the intervention (study weeks 12–14) and reassessed 12–14 weeks after completion of the intervention (study weeks 24–26). Deidentified data will be stored and managed using Research Electronic Data Capture electronic data capture tools hosted at Mount Sinai Hospital.59

Outcome measures

Outcome measure for primary objective

We will use the change in the six-item de Jong loneliness scale from baseline to 12 weeks as our primary outcome measure.50 51 60 This scale has been extensively validated in large populations of older individuals in many countries, and61 62 Its psychometric properties and normative population-based values from a wide variety of subgroups have been established.17 50 51 60 62 63 It has also used in population-based studies of older Canadians.50 51 60 62 64–66 Sustainability of all outcome measures will be assessed at 24 weeks.

Secondary outcome measures

Outcome for secondary objective 1

During screening for study eligibility, research staff will also ask participants to assess each of the six items of the de Jong scale using a five-item Likert scale: ‘(de Jong item) is much worse/a little worse/about the same/a little better/much better since COVID-19’. We will use this modified de Jong scale to assess the impact of COVID-19 on their current loneliness.

Outcome for secondary objectives 2 –6

Secondary outcome measures were chosen based on previous studies of ‘HOW RU?’ to assess multiple dimensions of health and include (2) the six-item Lubben’s Social Network Scale67; (3) the five-item Geriatric Depression Scale to assess mood68; (4) quality of life using the EQ-5D-5L,69 70 which measures health-related quality of life using a Visual Analogue Scale; (5) and functional status using the Older Americans Resource Scale.71 All outcome scales have been extensively validated in older people. (6) All-cause mortality will be recorded at 12 weeks following the intervention.

Outcome for secondary objective 7

We will assess our primary and secondary outcomes 12–14 weeks after intervention termination (24–26 weeks after intervention assignment) to assess the sustainability of impacts of the interventions.

All primary and secondary measures will be assessed by an outcome assessor who is blinded to the randomisation assignment.

Outcome for secondary objective 8

We will assess feasibility and process outcomes to help us interpret the study results and potentially improve our intervention in future trials. Outcomes include: (8.1) assessing the frequency and duration of peer-volunteer interactions with participants to assess intervention fidelity—note, content of discussion will not be recorded; (8.2) measuring participant preferences regarding delivery of HOW R U? by telephone or via a secure video-conferencing solution. (8.3) We will assess the rate of participant completion of both video and telephone versions of the intervention, as well as the reasons for withdrawal, including technological, physical and mental health issues. (8.4) We will assess the rate of volunteer completion of both video and telephone versions of the intervention, as well as the reasons for withdrawal, including technological, physical and mental health issues. Feasibility measures will be used to guide future sample size calculations and resource requests, and no arbitrary threshold for feasibility will be set a priori.

Pilot work and feasibility

Feasibility assessment was informed by previous studies conducted in Australia, in which 17 volunteers recruited 39 participants in 5 months (30% recruitment rate, with a 17% withdrawal rate),41 as well as from pilot work conducted between September and 31 October 2021. We found an 18% withdrawal rate, and an estimated enrolment rate of 10 eligible participants per month. Each volunteer will treat two participants for 12 weeks. We estimate that 20 volunteers could treat 170 participants in 16 months accounting for a 20% attrition rate for volunteers. In order to allow for turn-over time and to provide a larger volunteer pool to match with participants, we will attempt to recruit 35 volunteers.

Sample size

A sample of 47 subjects in each of three groups will have >80% power to detect a 13.9%–28.1% difference between the treatment and control groups in the proportion of people who have an improvement of 1 category in the de Jong 6 item loneliness scale, assuming the proportion of participants in the control group who have spontaneous improvement in loneliness categories of up to 15%.

This allows for three comparisons: (1) intervention group 1 versus standard care, (2) intervention group 2 versus standard care and (3) intervention group 1 versus intervention group 2 using a two sample, two-sided test of proportions. This sample also has 99% power to detect a 15% reduction in mean social isolation and depression (two sample two-sided t-test). Our pilot work revealed a withdrawal rate of 18% mirroring previous work by Lowthian, thus, we will recruit a total of 170 participants to retain 151 participants. All sample sizes were calculated using Process Automation Software System (PASS V.12 (NCSS).

Analysis

An intention-to-treat analysis will be used. For this three-arm trial, two intervention strategies (‘HOW R U?’ and aTouchAway+‘HOW R U?’) share a common control arm (no intervention). This approach is chosen to maximise efficiency, allowing comparison of two new interventions to usual care in a single three-armed trial. The two simultaneous primary analyses will compare intervention group 1 (‘HOW R U?’) to the standard care group and intervention group 2 (aTouchAway) to the standard care group. A secondary analysis will compare intervention group 1 (‘HOW R U?’) to intervention group 2 (aTouchAway).

We hypothesise that participants in the ‘HOW R U?’ telephone and ‘HOW R U?’ video groups will have superior outcomes compared with the standard care group. Because this trial is focused on answering the efficacy question for each intervention separately, and the interpretation of the results of one comparison have no direct bearing on the interpretation of the other, no multiplicity adjustment is required.72–74

The primary question will be answered by a two sample, two-sided test of proportions assessing loneliness for telephone delivered ‘HOW R U?’ vs standard care, and video-delivered delivered ‘HOW R U?’ versus standard care. In addition, we will run a logistic regression model with our binary outcome of loneliness improvement of at least one category of the de Jong loneliness scale. The logistic regression model will include our three level group variable as well as covariates of interest. Prior to model building, the set of predictors will be assessed for multicollinearity (a statistical concept where several independent variables in a model are correlated) by examining the variance inflation factor (VIF). If two variables show a high degree of correlation (a VIF above 4 or tolerance below 0.25), we will retain only one of the exploratory variables for the final model. The retained variable will be chosen based on (1) clinical relevance, (2) ease of collection and (3) completeness of data. The results of the logistic regression model will be reported as ORs and their associated 95% CIs. Participants lacking either a baseline or 12-week follow-up de Jong loneliness scale will be excluded from the primary analysis. Secondary outcomes will be reported as means and 95% CI where appropriate. All analyses will be run using SAS V.9.4 or later (SAS Institute).

Ethical and safety consideration

We have approval from the Mount Sinai Research Ethics Board (Toronto, Canada) to use a verbal consent model in light of COVID-19 restrictions. Patients will be informed at each referral source about the ongoing study. RAs will then contact eligible potential participants by telephone to seek verbal consent to conduct a screening interview. As with our previous research, we will use the Adamis capacity assessment model.75 Subjects who are able to demonstrate their understanding of the purpose of the study by repeating it back to the RA will be deemed to have capacity to assent to participation in this minimal risk study risks of peer support (sharing of misinformation, negative or intense emotions) are addressed in the training of peer-support volunteers. An emergency physician will be available to the peer supporter if any safety issues arise during all peer-support sessions (JSL). A similar approach was used in the previous proof-of-concept trial.40 41 No adverse experiences were reported and 87% of participants completed the 12-week intervention.

Dissemination

In addition to dissemination through peer-reviewed journal publication, our team will disseminate our results through the Geriatric EM Committee at the International Federation of Emergency Medicine, the SREMI International Advisory Board as well as through the use social media (@GEMSREMI, @geri_EM) and SREMI’s own podcasting resource, EMCases. EMCases ranks in the top five science/medicine podcasts in North America (number 2 in Canada) with a large following of healthcare workers from around the world.

Discussion

Social isolation and loneliness among older adults were problematic prior to the COVID-19 pandemic and have significantly worsened due to necessary physical distancing and self-isolation during the global pandemic.9 This proposed protocol will evaluate a strategy to reduce social isolation and loneliness that can be used despite public health physical distancing mandates with significant potential for sustainability and scalability. Although data are limited, Stats Canada found that 12.7 million Canadians, 41% of the population over 15 years old, volunteer and hospitals had the highest average number of hours.76 A 2013 UK report found over 3 million people volunteered in healthcare.77 Thus, personnel costs to implement the ‘HOW R U?’ intervention will be modest. As noted, the vast majority of older people have access to a mobile phone or landline.52 Given growing evidence of the effectiveness of video-conferencing for mental health interventions, this trial will also compare delivery of the ‘HOW R U?’ intervention by telephone to a video-conferencing version, as well as comparing both to a common standard care group. Testing the effectiveness of the ‘HOW R U?’ intervention in a new, North American context will provide important information about the generalisability of the intervention to other healthcare settings.

A limitation of the proposed trial that impacts internal validity is that it is not possible to blind participants to the intervention, although we have attempted to mitigate this through outcome-assessment blinding. Recall bias may impact recollection of loneliness pre-COVID-19. Not being able to deliver the intervention in languages other than English, that participants will need access to a telephone, are provided with a tablet, and that the trial is based in one city are limitations that impact the external validity or generalisability of the trial. If this explanatory trial is successful, future research to target especially vulnerable, socioeconomically disadvantaged and isolated populations is needed, and to assess the ‘real-world’ application of this intervention.

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