OsteoporosisiCARENCT05445336
The iCARE Study: Education Modules for Fracture Prevention
An observational study of Osteoporosis and Frailty, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteoporosis, Frailty, Chronic Conditions, Multiple
- What is being tested?
- PREVENT Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jul 2022to 15 Aug 2023
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Care planning in long term care is a collaborative effort between the resident, the long term care healthcare provider, and the resident's family/caregiver. An internal champion will be identified to represent several long term care homes and who will help identify the five Professional Advisory Committees care teams who are the end-users of the PREVENT program. The Professional Advisory Committee may consist of a Director of Care/Nursing Director, Medical Director, Clinical Consultant Pharmacist, and other participating members who may include dietitians, rehabilitation staff, nurses, physicians, and personal support workers.
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The iCARE Study: An Integrated Collection of Education Modules on Fall and Fracture Prevention for Healthcare Providers
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.
Read the detailed description
Fractures pose a significant burden on health, quality of life, and mortality of older adults in long term care (LTC) and contribute to high health care costs. PREVENT (Person-centred Routine Fracture PreEVENTion) is a scalable model for delivering routine assessments and interventions on diet and supplements, multifactorial fall and fracture prevention strategies, and medications to long term care teams to treat residents at high risk of fracture. The purpose of the iCARE study is to create a fall and fracture educational program (i.e., PREVENT) for LTC healthcare providers to deliver routine assessments for the management and treatment of osteoporosis. The benefit of such a guide may help to reduce the devastating impact of fractures in older adults residing in LTC homes. The aim of this pilot study is to: 1) determine feasibility and 2) adaptations through facilitators and barriers. Before a larger trial can be implemented to determine the effectiveness of the PREVENT Program in practice, the iCARE study seeks to determine the feasibility of implementing PREVENT in practice and identify strategies to tailor the program to the individual long term care home and care team through design thinking solutions.
- Conditions
- Osteoporosis, Frailty, Chronic Conditions, Multiple, Fracture
- Being tested
- PREVENT Program
- Keywords
- Frailty, Service Provision, Education, Knowledge Translation, Knowledge Mobilization, Osteoporosis, Fracture Prevention, Long Term Care
- Medical subject headings
- Osteoporosis, Frailty, Multiple Chronic Conditions, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREVENT ProgramBehavioural
PREVENT (Person-centred Routine Fracture PreEVENTion) is a scalable model for delivering routine assessments and interventions on diet and supplements, multifactorial fall and fracture prevention strategies, and medications to long term care teams to treat residents at high risk of fracture.
| Study group | Role | What they receive |
|---|---|---|
| Internal Champion & LTC Leadership Team #1 from Site #1 | The internal champion and LTC leadership team of each LTC home will attend two virtual focus group sessions to help co-design the PREVENT Program educational material. The internal champion will receive training on how to deliver the PREVENT program to the leadership team. The internal champion/pharmacist/data analyst will receive training on how to develop an audit and feedback report on fall and fracture management. All participants will attend an educational meeting facilitated by the internal champion who will use a combination of didactic and interactive activities. After the educational meeting, the leadership team will complete an action and care planning report for each LTC resident at high risk of fracture. Lastly, all participants will attend two virtual focus group sessions to discuss the successes and challenges of implementing the PREVENT program in practice. Receives: Behavioral: PREVENT Program | |
| Internal Champion & LTC Leadership Team #2 from Site #2 | The internal champion and LTC leadership team of each LTC home will attend two virtual focus group sessions to help co-design the PREVENT Program educational material. The internal champion will receive training on how to deliver the PREVENT program to the leadership team. The internal champion/pharmacist/data analyst will receive training on how to develop an audit and feedback report on fall and fracture management. All participants will attend an educational meeting facilitated by the internal champion who will use a combination of didactic and interactive activities. After the educational meeting, the leadership team will complete an action and care planning report for each LTC resident at high risk of fracture. Lastly, all participants will attend two virtual focus group sessions to discuss the successes and challenges of implementing the PREVENT program in practice. Receives: Behavioral: PREVENT Program | |
| Internal Champion & LTC Leadership Team #3 from Site #3 | The internal champion and LTC leadership team of each LTC home will attend two virtual focus group sessions to help co-design the PREVENT Program educational material. The internal champion will receive training on how to deliver the PREVENT program to the leadership team. The internal champion/pharmacist/data analyst will receive training on how to develop an audit and feedback report on fall and fracture management. All participants will attend an educational meeting facilitated by the internal champion who will use a combination of didactic and interactive activities. After the educational meeting, the leadership team will complete an action and care planning report for each LTC resident at high risk of fracture. Lastly, all participants will attend two virtual focus group sessions to discuss the successes and challenges of implementing the PREVENT program in practice. Receives: Behavioral: PREVENT Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment Rate
Number of long term care homes (LTCs) in Ontario recruited within two months. Criteria for success: recruit 5 LTC homes in Ontario within 2 months
Measured: 2 months
Feasibility - LTC home readiness and capacity
Determine long term care home readiness and capacity to participate in the iCARE study based on a Readiness Checklist Survey. Criteria for success: at least 75% of homes approached are ready and have the capacity to participate in the study
Measured: 1 month
Feasibility - Length of time to complete PREVENT Program
Length of time for participants to implement the PREVENT Program
Measured: 4 months
Feasibility - Logistics of linking data (Yes/No format)
Determine the logistics of linking MDS 2.0 data with pharmaceutical database data at the resident level. This will be assessed by a "yes" or "no" (i.e., Feasible - Yes vs. Feasible - No)
Measured: 4 months
Fidelity of delivering the PREVENT program
Determine the fidelity of delivering the PREVENT program. Criteria for success: ≥ 80% on the fidelity checklist.
Measured: 4-6 months
Feasibility - Number of Questions Completed
The number of questions answered by the participants for each questionnaire. Criteria for success is 80% of questions are completed.
Measured: 4 months
Secondary outcomes (2)
Changes in Prescribing Habits
To determine if appropriate prescribing habits change after the educational session. The criteria for success is a 10% improvement in prescribing habits. This will be measured by the number of prescriptions per number of residents at high risk of fracture pre- vs. post-intervention.
Measured: 4-6 months
Adaptations to PREVENT Program
To determine adaptations to the PREVENT program by facilitating two 1.5-hour focus group sessions (semi-structured interviews) with the leadership team to 1) discuss facilitators of and barriers to implementing the PREVENT program and 2) make necessary changes to the PREVENT program/educational material catered to the individual LTC home.
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start30 Jul 2022
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Responsible party
- Principal investigator, Alexandra Papaioannou, Hamilton Health Sciences Corporation
- Investigators
- Alexandra Papaioannou, MD, MSc, FRCP(c), FACP, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445336
- Sponsor's protocol ID
- 14463
- Acronym
- iCARE
- Status last verified
- Dec 2023
- First submitted
- 28 Jan 2022
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The iCARE Study: An Integrated Collection of Education Modules on Fall and Fracture Prevention for Healthcare Providers
- ClinicalTrials.gov ID
- NCT05445336
- Acronym / sponsor ID
- iCARE / 14463
- Conditions
- Osteoporosis, Frailty, Chronic Conditions, Multiple, Fracture
- Keywords
- Frailty, Service Provision, Education, Knowledge Translation, Knowledge Mobilization, Osteoporosis, Fracture Prevention, Long Term Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fractures pose a significant burden on health, quality of life, and mortality of older adults in long term care (LTC) and contribute to high health care costs. PREVENT (Person-centred Routine Fracture PreEVENTion) is a scalable model for delivering routine assessments and interventions on diet and supplements, multifactorial fall and fracture prevention strategies, and medications to long term care teams to treat residents at high risk of fracture. The purpose of the iCARE study is to create a fall and fracture educational program (i.e., PREVENT) for LTC healthcare providers to deliver routine assessments for the management and treatment of osteoporosis. The benefit of such a guide may help to reduce the devastating impact of fractures in older adults residing in LTC homes. The aim of this pilot study is to: 1) determine feasibility and 2) adaptations through facilitators and barriers. Before a larger trial can be implemented to determine the effectiveness of the PREVENT Program in practice, the iCARE study seeks to determine the feasibility of implementing PREVENT in practice and identify strategies to tailor the program to the individual long term care home and care team through design thinking solutions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internal Champion & LTC Leadership Team #1 from Site #1 | – | Behavioral: PREVENT ProgramThe internal champion and LTC leadership team of each LTC home will attend two virtual focus group sessions to help co-design the PREVENT Program educational material. The internal champion will receive training on how to deliver the PREVENT program to the leadership team. The internal champion/pharmacist/data analyst will receive training on how to develop an audit and feedback report on fall and fracture management. All participants will attend an educational meeting facilitated by the internal champion who will use a combination of didactic and interactive activities. After the educational meeting, the leadership team will complete an action and care planning report for each LTC resident at high risk of fracture. Lastly, all participants will attend two virtual focus group sessions to discuss the successes and challenges of implementing the PREVENT program in practice. |
| Internal Champion & LTC Leadership Team #2 from Site #2 | – | Behavioral: PREVENT ProgramThe internal champion and LTC leadership team of each LTC home will attend two virtual focus group sessions to help co-design the PREVENT Program educational material. The internal champion will receive training on how to deliver the PREVENT program to the leadership team. The internal champion/pharmacist/data analyst will receive training on how to develop an audit and feedback report on fall and fracture management. All participants will attend an educational meeting facilitated by the internal champion who will use a combination of didactic and interactive activities. After the educational meeting, the leadership team will complete an action and care planning report for each LTC resident at high risk of fracture. Lastly, all participants will attend two virtual focus group sessions to discuss the successes and challenges of implementing the PREVENT program in practice. |
| Internal Champion & LTC Leadership Team #3 from Site #3 | – | Behavioral: PREVENT ProgramThe internal champion and LTC leadership team of each LTC home will attend two virtual focus group sessions to help co-design the PREVENT Program educational material. The internal champion will receive training on how to deliver the PREVENT program to the leadership team. The internal champion/pharmacist/data analyst will receive training on how to develop an audit and feedback report on fall and fracture management. All participants will attend an educational meeting facilitated by the internal champion who will use a combination of didactic and interactive activities. After the educational meeting, the leadership team will complete an action and care planning report for each LTC resident at high risk of fracture. Lastly, all participants will attend two virtual focus group sessions to discuss the successes and challenges of implementing the PREVENT program in practice. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Care planning in long term care is a collaborative effort between the resident, the long term care healthcare provider, and the resident's family/caregiver. An internal champion will be identified to represent several long term care homes and who will help identify the five Professional Advisory Committees care teams who are the end-users of the PREVENT program. The Professional Advisory Committee may consist of a Director of Care/Nursing Director, Medical Director, Clinical Consultant Pharmacist, and other participating members who may include dietitians, rehabilitation staff, nurses, physicians, and personal support workers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREVENT ProgramPREVENT (Person-centred Routine Fracture PreEVENTion) is a scalable model for delivering routine assessments and interventions on diet and supplements, multifactorial fall and fracture prevention strategies, and medications to long term care teams to treat residents at high risk of fracture. | Behavioural | Internal Champion & LTC Leadership Team #1 from Site #1, Internal Champion & LTC Leadership Team #2 from Site #2, Internal Champion & LTC Leadership Team #3 from Site #3 |
Primary outcome
Feasibility - Recruitment Rate
Time frame: 2 months
Number of long term care homes (LTCs) in Ontario recruited within two months. Criteria for success: recruit 5 LTC homes in Ontario within 2 months
Feasibility - LTC home readiness and capacity
Time frame: 1 month
Determine long term care home readiness and capacity to participate in the iCARE study based on a Readiness Checklist Survey. Criteria for success: at least 75% of homes approached are ready and have the capacity to participate in the study
Feasibility - Length of time to complete PREVENT Program
Time frame: 4 months
Length of time for participants to implement the PREVENT Program
Feasibility - Logistics of linking data (Yes/No format)
Time frame: 4 months
Determine the logistics of linking MDS 2.0 data with pharmaceutical database data at the resident level. This will be assessed by a "yes" or "no" (i.e., Feasible - Yes vs. Feasible - No)
Fidelity of delivering the PREVENT program
Time frame: 4-6 months
Determine the fidelity of delivering the PREVENT program. Criteria for success: ≥ 80% on the fidelity checklist.
Feasibility - Number of Questions Completed
Time frame: 4 months
The number of questions answered by the participants for each questionnaire. Criteria for success is 80% of questions are completed.
2 secondary outcomes
Changes in Prescribing Habits
Time frame: 4-6 months
Adaptations to PREVENT Program
Time frame: 4-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Papaioannou, MD, MSc, FRCP(c), FACP principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Frailty, run by McMaster University 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?
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 1 Jul 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?
Feasibility - Recruitment Rate (time frame: 2 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2025.