NCT04523610

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 2, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

May 25, 2025

Status Verified

September 1, 2020

Enrollment Period

12 months

First QC Date

July 16, 2020

Last Update Submit

May 21, 2025

Conditions

Keywords

Mental HealthTeleheathVolunteerCOVID-19Older Adults

Outcome Measures

Primary Outcomes (5)

  • 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).

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

  • 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).

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

  • 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".

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

  • 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).

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

  • Mental Healthcare Utilization

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

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

Secondary Outcomes (3)

  • Interviews and Focus Groups with Volunteers

    8-weeks (2 hours)

  • Interviews and Focus Groups with Stakeholders

    8-weeks (2 hours)

  • Interviews with Program Users

    8-weeks (2 hours)

Study Arms (4)

Program Users - Quantitative

EXPERIMENTAL

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, 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.

Behavioral: Telehealth phone calls

Program Users - Qualitative

OTHER

Interviews will be conducted with 25 participants regarding their perceptions and experiences in the TIP-OA program.

Behavioral: Telehealth phone calls

Volunteers - Qualitative

OTHER

15 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.

Other: Volunteer of TIP-OA Program

Stakeholders - Qualitative

OTHER

18 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.

Other: Stakeholder of TIP-OA Program

Interventions

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).

Program Users - QualitativeProgram Users - Quantitative

Participant is a volunteer of the TIP-OA Program

Volunteers - Qualitative

Participant is a stakeholder of the TIP-OA Program

Stakeholders - Qualitative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Not capable of giving consent (vetted for this by the clinician team)
  • TIP-OA program volunteer
  • Able to speak English or French
  • None
  • TIP-OA program stakeholder (community partners, program organizers, and clinicians)
  • Able to speak English or French
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Community and Family Psychiatry

Montreal, Quebec, H3T 1E4, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionAnxiety DisordersCognitive DysfunctionPsychological Well-BeingCOVID-19

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersCognition DisordersNeurocognitive DisordersPersonal SatisfactionPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Soham Rej, MD/MSc

    Lady Davis Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This is a mixed-methods (qualitative and quantitative) model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 16, 2020

First Posted

August 21, 2020

Study Start

October 2, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2022

Last Updated

May 25, 2025

Record last verified: 2020-09

Locations