Telehealth Intervention Program for Older Adults (NCT04523610) | Clinical Trial Compass
CompletedNot Applicable
Telehealth Intervention Program for Older Adults
Canada112 participantsStarted 2020-10-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Perceived Stress Scale (PSS)
Timeframe: Change from Baseline to 4- and 8-weeks (15 minute assessment)
2
Patient Health Questionnaire-9 (PHQ-9)
Timeframe: Change from Baseline to 4- and 8-weeks (15 minute assessment)
3
Generalized Anxiety Disorder-7 (GAD-7)
Timeframe: Change from Baseline to 4- and 8-weeks (15 minute assessment)
4
Fear of COVID-19 Scale
Timeframe: Change from Baseline to 4- and 8-weeks (15 minute assessment)
5
Mental Healthcare Utilization
Timeframe: Assessed in the 8 weeks prior to baseline and during the 8-week follow-up