Comprehensive Risk Assessment and Prevention Plan of Osteoporosis and Sarcopenia for the Elderly Participating in Community-based Long-term Care Services
1 other identifier
interventional
600
1 country
1
Brief Summary
The purpose of this project is:
- 1.Provide the epidemiological data of the prevalence, incidence, and risk factors of osteoporosis and sarcopenia among the elderly in rural areas.
- 2.Screen osteoporosis and sarcopenia among the elderly and provide with assistance for following care in order to improve the diagnosis and treatment rates of osteoporosis and sarcopenia
- 3.Construct a pragmatic and integrated care service model for osteoporosis and sarcopenia in the elderly people from rural areas
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2021
CompletedFirst Submitted
Initial submission to the registry
October 11, 2021
CompletedFirst Posted
Study publicly available on registry
November 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 15, 2024
September 1, 2023
4.3 years
October 11, 2021
April 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The changes of Quality of life and quality adjusted life year
Using EQ5D / WHOQOL Brief questionnaires to measure quality of life and evaluate the changes after intervention. In addition, to calculate quality adjusted life year by using utility index derived from qualify of life measurement.
one year, two year, 3 year, four year
Intrinsic capacity
To define if the Intrinsic capacity would be changed after intervention
one year, two year, 3 year, four year
Institutionalilzation rate
To define if the Institutionalilzation rate would be changed after intervention
one year, two year, 3 year, four year
Secondary Outcomes (3)
Incidence of fall
one year, two year, 3 year, four year
Incidence of fracture
one year, two year, 3 year, four year
Incidence of unexpected hospitalization
one year, two year, 3 year, four year
Other Outcomes (8)
Incidence of mortality
one year, two year, 3 year, four year
Changes of drug related problems
one year, two year, 3 year, four year
Phyiscal performance
one year, two years
- +5 more other outcomes
Study Arms (3)
Screening group
EXPERIMENTALInform the elderly about the results of the screening and recommend those with moderate to high risk of fracture to receive active examination and treatment.
Multi-component integrated intervention
EXPERIMENTALIntroduce integrated services of health education, nutrition, rehabilitation, pharmaceutical care, and other multi-specialties to assist study participants with health promotion
Delayed intervention
PLACEBO COMPARATORreceive general care after collecting basic information, and provide health education related information such as osteoporosis sarcopenia. After two year's follow-up, multi-disciplinary team intervention service will be implemented.
Interventions
All residents underwent screening using the Fracture Risk Assessment Tool (FRAX) and Mobile dual-energy X-ray absorptiometry (DXA) (Horizon Wi, Hologic Inc., Bedford, MA). Our study nurses actively assisted osteoporosis treatment if indicated.
Sarcopenia assessment adhered to the 2019 Consensus Update on Sarcopenia Diagnosis and Treatment by the Asian Working Group for Sarcopenia guideline. Following screening, individuals identified with sarcopenia underwent tailored interventions involving exercise and nutrition as deemed necessary.
TheraBand (resistance band) was utilized as the exercise tool within the community. T
Nutrition Nutritional education programs aim to increase protein food serving and the choice of those with insufficient dietary intake. Protein supplement was added if indicated.
We collected drug information of the elderly. Detailed and real-time prescription drug information was retrieved from the National Health Insurance PharmaCloud System. A pharmaceutical care team performed patient-centered drug review and discussion every three to six months.
Eligibility Criteria
You may qualify if:
- Age≥ 50 old and lived in the community
You may not qualify if:
- Life expectancy less than two years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital, Yunlin branch
Douliu, Yunlin County, Taiwan
Related Publications (1)
Fu SH, Lai WJ, Yen HK, Kukreti S, Li CY, Hung CC, Wang CY. Addressing healthcare disparities and improving osteoporosis management in rural communities: a cluster randomized control trial. Arch Osteoporos. 2025 Jan 28;20(1):15. doi: 10.1007/s11657-025-01498-4.
PMID: 39875677DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2021
First Posted
November 2, 2021
Study Start
September 17, 2021
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
April 15, 2024
Record last verified: 2023-09