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Completed

NCT Number: NCT05445336

The iCARE Study: Education Modules for Fracture Prevention

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Chronic Conditions, Multiple Chronic Disease Disease Attributes Fracture Fractures, Bone Frailty Metabolic Diseases Multiple Chronic Conditions Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GERAS Centre for Aging Research

Hamilton, Ontario, N3T 5M1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PREVENT Program

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. Feasibility - Length of time to complete PREVENT Program

    Time frame: 4 months

    Length of time for participants to implement the PREVENT Program

  4. 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)

  5. 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.

  6. 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.

Secondary outcomes

  1. Changes in Prescribing Habits

    Time frame: 4-6 months

    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.

  2. Adaptations to PREVENT Program

    Time frame: 4-6 months

    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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Hamilton Health Sciences Corporation

Registry information

Official study title

The iCARE Study: An Integrated Collection of Education Modules on Fall and Fracture Prevention for Healthcare Providers

Acronym: iCARE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2022
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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