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Depression, AnxietyTIP-OANCT04523610

Telehealth Intervention Program for Older Adults

A study testing Telehealth phone calls, Volunteer of TIP-OA Program and Stakeholder of TIP-OA Program in people with Depression, Anxiety and Cognitive Impairment, run by Lady Davis Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Depression, Anxiety, Cognitive Impairment, Stress
What is being tested?
Telehealth phone calls, Volunteer of TIP-OA Program and Stakeholder of TIP-OA Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteCanada
Study dates
2 Oct 2020to 1 Oct 2022
Phase
Interventional
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
  • TIP-OA program volunteer
Show all 9Show fewer
  • Able to speak English or French
  • TIP-OA program stakeholder (community partners, program organizers, and clinicians)
  • Able to speak English or French

Who cannot join

  • Not capable of giving consent (vetted for this by the clinician team)
  • None
  • None

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Institute of Community and Family Psychiatry

    Montreal, Quebec, H3T 1E4

Other trials in Canada

About this study

Official title: Telehealth Intervention Program for Older Adults (TIP-OA) Struggling With Mental Health/Cognitive Issues

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.

Read the 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.

Being tested
Telehealth phone calls, Volunteer of TIP-OA Program, Stakeholder of TIP-OA Program
Keywords
Mental Health, Teleheath, Volunteer, COVID-19, Older Adults
Medical subject headings
Depression, Anxiety Disorders, Cognitive Dysfunction, Psychological Well-Being, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telehealth phone callsBehavioural

    The volunteer-based weekly Telehealth support primarily provides program users with friendly listening/conversation. Volunteers will also inquire about their general wellbeing, provide information about COVID-19, and ask if the older adult needs any help or support (e.g. food delivery, medication from their pharmacy).

  • Volunteer of TIP-OA ProgramOther

    Participant is a volunteer of the TIP-OA Program

  • Stakeholder of TIP-OA ProgramOther

    Participant is a stakeholder of the TIP-OA Program

Study groups in NCT04523610
Study groupRoleWhat they receive
Program Users - QuantitativeExperimentalThe 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, trained volunteers provide friendly phone calls once a week to older adults (age 60+). 200 participants will be recruited for the quantitative component of the study.
Receives: Behavioral: Telehealth phone calls
Program Users - QualitativeOtherInterviews will be conducted with 25 participants regarding their perceptions and experiences in the TIP-OA program.
Receives: Behavioral: Telehealth phone calls
Volunteers - QualitativeOther15 volunteers taking part in the semi-structured interviews and 16 volunteers participating in the focus groups. The interviews and focus groups will evaluate their roles, experiences, and challenges volunteering with the TIP-OA program.
Receives: Other: Volunteer of TIP-OA Program
Stakeholders - QualitativeOther18 stakeholders (clinicians, community partners, TIP-OA team members) will participate in focus groups and interviews. Specifically, 10 clinicians will participate in one focus group and 8 community partners/team members will participate in interviews. The interviews and focus groups will evaluate their roles, experiences, and challenges volunteering with the TIP-OA program.
Receives: Other: Stakeholder of TIP-OA Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived Stress Scale (PSS)

    Perceived Stress Scale (PSS) is a 14-item scale used to measure the degree to which life events are experienced and appraised as stressful. It asks respondents about how often they have felt certain ways in the past month, with responses ranging from 0 (never) to 4 (very often).

    Measured: Change from Baseline to 4- and 8-weeks (15 minute assessment)

  2. Patient Health Questionnaire-9 (PHQ-9)

    Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report questionnaire used to diagnose depression and assess symptom severity. The questionnaire asks individuals how often in the last two weeks they have been bothered by problems like "feeling down, depressed, and hopeless" and "poor appetite or overeating." Scores for each question include 0 (not at all), 1 (several days), 2 (more than half of the days), and 3 (nearly every day).

    Measured: Change from Baseline to 4- and 8-weeks (15 minute assessment)

  3. Generalized Anxiety Disorder-7 (GAD-7)

    Generalized Anxiety Disorder-7 (GAD-7) is a 7-item scale that measures symptoms of anxiety present in the previous 2 weeks. Respondents can choose from a score of 0 (not at all sure), 1 (several days), 2 (over half the days), or 3 (nearly every day). Items include "Not being able to stop or control worrying" and "Being so restless that it's hard to sit still".

    Measured: Change from Baseline to 4- and 8-weeks (15 minute assessment)

  4. Fear of COVID-19 Scale

    Fear of COVID-19 Scale is an 18-item scale measuring individuals' anxiety, fear and concern surrounding the COVID-19 pandemic. Items include: "Fear that I will be infected" and "Worry if I will be assigned to COVID wards if hospitalized" (34).

    Measured: Change from Baseline to 4- and 8-weeks (15 minute assessment)

  5. Mental Healthcare Utilization

    Mental healthcare utilization will be assessed using medical records, including the number of ER visits, hospitalizations, and outpatient visits

    Measured: Assessed in the 8 weeks prior to baseline and during the 8-week follow-up

Secondary outcomes (3)
  1. Interviews and Focus Groups with Volunteers

    What are the roles, contributions, and challenges of volunteers in identifying the needs of program users and volunteers, providing access to services, and creating appropriate responses to identified needs for the success and efficacy of the program?

    Measured: 8-weeks (2 hours)

  2. Interviews and Focus Groups with Stakeholders

    What are the roles, contributions, and challenges of different stakeholders (e.g. community partners, program organizers, and clinicians) in identifying the needs of program users and volunteers, providing access to services, and creating appropriate responses to identified needs for the success and efficacy of the program?

    Measured: 8-weeks (2 hours)

  3. Interviews with Program Users

    What are the experiences and evaluation of the program users about their engagement with the TIP-OA? Has the program contributed in improving the health of the program users?

    Measured: 8-weeks (2 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2020
  2. Study start2 Oct 2020
  3. Primary completion1 Oct 2021
  4. Study completion1 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
This is a mixed-methods (qualitative and quantitative) model
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04523610
Sponsor's protocol ID
TIP-OA
Acronym
TIP-OA
Status last verified
Sep 2020
First submitted
16 Jul 2020
Last updated
25 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Rigas C, Lavin P, Su CL, Hassan M, Cinalioglu K, Vacaflor B, Dikaios E, Goodman A, Ibrahim M, Gruber J, Se J, Sasi N, Nazar R, Bodenstein K, Elbaz S, Fajzel H, Berkani S, Hanganu C, Noble H, Looper K, Bouchard S, Seitz D, Kumar S, Beauchet O, Launay C, McDonald E, Khoury B, Ryder A, Battistini B, Fallavollita P, Vahia I, Sekhon H, Bukhari S, Rej S. Optimizing future Telehealth mental health programs: a secondary analysis of a prospective cohort study to identify key predictors of intervention response in the Telehealth intervention program for older adults (TIP-OA). BMC Psychiatry. 2026 Mar 31;26(1):385. doi: 10.1186/s12888-025-07688-1.

    PubMed 41917885
  • 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.

    PubMed 33343425

Questions about this trial

What is this clinical trial studying?

A study testing Telehealth phone calls, Volunteer of TIP-OA Program and Stakeholder of TIP-OA Program in people with Depression, Anxiety and Cognitive Impairment, run by Lady Davis Institute at 1 site in Canada.

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 3 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: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Stress Scale (PSS) (time frame: Change from Baseline to 4- and 8-weeks (15 minute assessment)). The study lists 5 primary outcomes in all. 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 NCT04523610, which also lists 2 linked publications.

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 25 May 2025.

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