Clinical trial NCT04523610: Telehealth Intervention Program for Older Adults
Official title: Telehealth Intervention Program for Older Adults (TIP-OA) Struggling With Mental Health/Cognitive Issues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Cognitive Impairment
Stress
Keywords: Mental Health
Teleheath
Volunteer
COVID-19
Older Adults
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a mixed-methods (qualitative and quantitative) model
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: COVID-19 is having profound effects on older adults' due to social isolation measures which may negatively impact individuals' mental and physical health. Recently, a telephone program, the Telehealth Intervention Program for Older Adults (TIP-OA), was created. In this program, a volunteer is calling older adults (age≥60) every week to have a friendly conversation. The objective of this study is to evaluate the effectiveness of this telephone program (TIP-OA) in reducing stress, improving the mental health of program users, and understand their experiences.

Detailed description: Social isolation has profound negative impacts on the mental health of older adults (generally those aged ≥60), such as stress, anxiety, cognitive decline, and depression. Depression is the #1 cause of disability worldwide. Prior to the pandemic, mental disorders were affecting \>10-15% older adults and more than 1,000,000 Canadians, with an estimated annual cost of $15 billion, which will increase with COVID-19.

There are 4.5 billion people globally in voluntary confinement and practicing social distancing. Older adults are more isolated and face risks to their health: i.e. increased risk for depression, ER visits and hospital admissions. Older isolated individuals are 4-5 times more likely to be rehospitalized. Moreover, older adults with stress, anxiety, and/or depression, have 50% higher healthcare costs and at 2 times increased mortality. Together these factors threaten to further overwhelm a healthcare system already strained from managing the direct morbidity and mortality of COVID-19.

During the pandemic, with an increased burden on health professionals who can be burnt out, reassigned, or infected with COVID-19, engaging lay volunteers may be beneficial to increase capacity. During COVID, many people are currently unable to work/study, are underemployed/unemployed, and able to volunteer. In a low-resource part of India, an in-person lay volunteer intervention was able to improve depression and other mental health symptoms in older adults. However, a systematic review of volunteer interventions in older individuals with mental health found that the evidence-base is limited with small sample sizes, few randomized controlled trials, especially for remote service delivery. Telehealth has been successful in connecting with socially isolated adults. Telehealth can be adopted in areas where healthcare access is limited and has evidence for improving depression and anxiety. However, telehealth programs that use the internet, tablets, smartphones apps or computers may not be accessible to or preferred by older adults; a survey of 500 older adults found that while only 10% used the internet, 77% did own a mobile phone. In the current COVID-19 context, many such interventions are not feasible for rapid implementation due to lack of infrastructure, training, and low rates of digital literacy in older adults. In a telephoning initiative prior to COVID, older isolated adults reported forming satisfying relationships as well as gaining confidence, engaging in the community and being more socially active. Given these limitations and need for immediate support for vulnerable older adults facing isolation during COVID-19, telephone-based support with volunteers is considered a potential fast, inexpensive, scalable, and convenient intervention option requiring further investigation.

The Telehealth Intervention Program (TIP-OA) for older adults was created during the COVID-19 pandemic to support the health of older adults who are isolated or have mental health/cognitive issues. Within the TIP-OA program, volunteers provide friendly phone calls once a week to older adults (age 60+).

The TIP-OA program provides once a week friendly phone calls from trained volunteers to older adults (age 60+), particularly to older adults struggling with mental health/cognitive issues. The clinical program does not provide any kind of treatment to the program user. Rather, the volunteer-based friendly telephone/telehealth calls adopt a simple and proactive communication technique: e.g., calling seniors to inquire about their general wellbeing, giving out information about COVID-19, asking if the seniors need any help or support (e.g. food delivery, medication from their pharmacy), connecting seniors with community organizations offering services (e.g. grocery delivery), or just talking and giving friendly company on the phone to increase a sense of connection. Moreover, program users are given a phone number for queries, comments, or complaints regarding the program or their volunteer. This study evaluates the effectiveness of the clinical service TIP-OA in 1) reducing stress (Perceived Stress Scale), 2) improving the mental health of service users (Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Fear of COVID-19 Scale), 3) improving mental healthcare utilization (e.g. hospital visits, hospitalizations, and outpatient visits), 4) compare mental health outcomes based on service users baseline risk, as well as 5) understand the experiences of service users, volunteers, and other stakeholders to improve TIP-OA and related future programs.

Using mixed-methods, the impact of the program will be evaluated systematically. The investigators will assess mental health outcomes in 200 older adults at baseline, 4- and 8-weeks (primary study endpoint). In addition, the investigators will perform qualitative analyses focus groups and/or individual semi-structured interviews with older adult participants, volunteers, community partners, and team members. The investigators anticipate that the TIP-OA program will be associated with improvements in stress, anxiety, and depression. If this is indeed the case, the investigators hope to share results with colleagues who could also develop similar programs internationally.

Eligibility criteria: Inclusion Criteria: Program Users

* TIP-OA Program User
* Aged ≥60 years
* Residing in Montreal
* Speak English or French
* Capable of giving consent (judged by a member of the research team to adequately understand information relevant in making a decision about research participation, and to reasonably appreciate foreseeable consequences of a decision or lack of decision)

Exclusion Criteria: Program Users

* Not capable of giving consent (vetted for this by the clinician team)

Inclusion Criteria: Volunteers

* TIP-OA program volunteer
* Able to speak English or French

Exclusion Criteria: Volunteers

* None

Inclusion Criteria: Stakeholders

* TIP-OA program stakeholder (community partners, program organizers, and clinicians)
* Able to speak English or French

Exclusion Criteria: Stakeholders

* None

Primary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Change from Baseline to 4- and 8-weeks (15 minute assessment)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from Baseline to 4- and 8-weeks (15 minute assessment)
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Change from Baseline to 4- and 8-weeks (15 minute assessment)
measure: Fear of COVID-19 Scale
timeFrame: Change from Baseline to 4- and 8-weeks (15 minute assessment)
measure: Mental Healthcare Utilization
timeFrame: Assessed in the 8 weeks prior to baseline and during the 8-week follow-up
Secondary outcomes:
measure: Interviews and Focus Groups with Volunteers
timeFrame: 8-weeks (2 hours)
measure: Interviews and Focus Groups with Stakeholders
timeFrame: 8-weeks (2 hours)
measure: Interviews with Program Users
timeFrame: 8-weeks (2 hours)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Institute of Community and Family Psychiatry
state: Quebec
Study officials:
affiliation: Lady Davis Institute
name: Soham Rej, MD/MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dikaios E, Sekhon H, Allard A, Vacaflor B, Goodman A, Dwyer E, Lavin-Gonzalez P, Mahdanian A, Park H, Walsh C, Sasi N, Nazar R, Gruber J, Su CL, Hanganu C, Royal I, Schiavetto A, Cinalioglu K, Rigas C, Launay C, Beauchet O, McDonald E, Seitz D, Kumar S, Nair V, Miresco M, Bruneau MA, Alexopoulos G, Looper K, Vahia I, Rej S, Bukhari SN. Connecting During COVID-19: A Protocol of a Volunteer-Based Telehealth Program for Supporting Older Adults' Health. Front Psychiatry. 2020 Dec 2;11:598356. doi: 10.3389/fpsyt.2020.598356. eCollection 2020.