CompletedNot Applicable

The iCARE Study: Education Modules for Fracture Prevention

Canada40 participantsStarted 2022-07-30

Plain-language summary

A large proportion of older adults living in long term care homes are frail and have osteoporosis. With age, there is a gradual and progressive decline in bone quality and quantity and an increase in frailty, which is associated with increased fracture risk. Additionally, fractures pose a significant burden to the health and quality of life of long term care residents and contribute to high healthcare costs. Despite the high prevalence of osteoporosis, falls, and fractures in long term care, the management of osteoporosis is not optimal among long term care residents at risk of fracture. The aim of this study is to co-design a service provision (i.e., PREVENT - Person-centred Routine Fracture PreEVENTion) with healthcare providers in long term care and to determine the feasibility of implementing PREVENT in long term care settings.

Who can participate

Age range

18 Years – 100 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.

Organizational Level Inclusion Criteria: Five long LTC homes in Ontario that * Have a minimum of 70 residents * Are publicly owned and private for-profit and private not-for-profit homes in both urban and rural sites Individual Level Inclusion Criteria: * At least one internal champion * Five Professional Advisory Committee (PAC) care teams from five long term care homes in Ontario that provide osteoporosis care to residents.

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

Feasibility - Recruitment Rate

Timeframe: 2 months

Feasibility - LTC home readiness and capacity

Timeframe: 1 month

Feasibility - Length of time to complete PREVENT Program

Timeframe: 4 months

Feasibility - Logistics of linking data (Yes/No format)

Timeframe: 4 months

Fidelity of delivering the PREVENT program

Timeframe: 4-6 months

Feasibility - Number of Questions Completed

Timeframe: 4 months

Trial details

NCT IDNCT05445336

SponsorMcMaster University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-08-15

View on ClinicalTrials.gov More Osteoporosis trials

Plain-language summary

Who can participate

Age range

18 Years – 100 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.

What they're measuring

Feasibility - Recruitment Rate

Timeframe: 2 months

Feasibility - LTC home readiness and capacity

Timeframe: 1 month

Feasibility - Length of time to complete PREVENT Program

Timeframe: 4 months

Feasibility - Logistics of linking data (Yes/No format)

Timeframe: 4 months

Fidelity of delivering the PREVENT program

Timeframe: 4-6 months

Feasibility - Number of Questions Completed

Timeframe: 4 months