The iCARE Study: Education Modules for Fracture Prevention

Status Completed

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05445336
Study type	Observational
Source	McMaster University
Contact
Status	Completed
Phase
Start date	July 30, 2022
Completion date	August 15, 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06287502` - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis	N/A
Completed	`NCT03822078` - Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women	Phase 1
Recruiting	`NCT05845021` - Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty	N/A
Completed	`NCT00092066` - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)	Phase 3
Recruiting	`NCT04754711` - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition	N/A
Completed	`NCT04736693` - Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
Not yet recruiting	`NCT06431867` - Primary Care Management of Osteoporosis in Older Women
Completed	`NCT02922478` - Role of Comorbidities in Chronic Heart Failure Study
Recruiting	`NCT02616627` - Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
Recruiting	`NCT02635022` - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Active, not recruiting	`NCT02617303` - Prevention of Falls and Its Consequences in Elderly People	N/A
Completed	`NCT02566655` - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis	Phase 1
Completed	`NCT03420716` - Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women	N/A
Completed	`NCT02559648` - Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis	Phase 2
Not yet recruiting	`NCT02223572` - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture	N/A
Unknown status	`NCT01913834` - Nasally and sc Administered Teriparatide in Healthy Volunteers	Phase 1
Not yet recruiting	`NCT01854086` - Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday	N/A
Completed	`NCT02003716` - DeFRA Questionnaire as an Anamnestic Form	N/A
Completed	`NCT02143674` - Muscle Strengthening Exercises and Global Stretching in Elderly	N/A
Completed	`NCT01401556` - C-STOP Fracture Trial	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The iCARE Study: Education Modules for Fracture Prevention — iCARE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms