Comprehensive Risk Assessment and Prevention Plan of Osteoporosis and Sarcopenia for the Elderly Participating in Community-based Long-term Care Services

Not Applicable

Recruiting

• Conditions: Osteoporosis; Frailty; Sarcopenia
• Interventions: Behavioral: Osteoporosis screening and treatment as needed; Behavioral: Sarcopenia; Behavioral: Exercise; Dietary Supplement: Nutrition; Behavioral: Pharmaceutical care

• Registration Number: NCT05104034
• Lead Sponsor: National Taiwan University Hospital

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

Detailed Description

Detailed Description:

Investigators plan to use a stepped-wedge cluster randomized trial that allocates participants into the following three groups:

1. Screening group: Inform the elderly about the results of the screening and recommend those with moderate to high risk of fracture to receive active examination and treatment.

2. Multi-disciplinary team intervention group: Introduce integrated services of health education, nutrition, rehabilitation, medication evaluation and other multi-specialties to assist study participants with health promotion.

3. Control group (Delayed intervention): receive 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.

Study Timeline

• Study Start: 2021-09-17
• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-11-02
• Status Verified: 2023-09
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Age≥ 50 old and lived in the community

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Exclusion Criteria

• Life expectancy less than two years

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Screening group	Osteoporosis screening and treatment as needed	Inform 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	Nutrition	Introduce integrated services of health education, nutrition, rehabilitation, pharmaceutical care, and other multi-specialties to assist study participants with health promotion
Multi-component integrated intervention	Exercise	Introduce integrated services of health education, nutrition, rehabilitation, pharmaceutical care, and other multi-specialties to assist study participants with health promotion
Multi-component integrated intervention	Pharmaceutical care	Introduce integrated services of health education, nutrition, rehabilitation, pharmaceutical care, and other multi-specialties to assist study participants with health promotion
Multi-component integrated intervention	Osteoporosis screening and treatment as needed	Introduce integrated services of health education, nutrition, rehabilitation, pharmaceutical care, and other multi-specialties to assist study participants with health promotion
Multi-component integrated intervention	Sarcopenia	Introduce integrated services of health education, nutrition, rehabilitation, pharmaceutical care, and other multi-specialties to assist study participants with health promotion
Delayed intervention	Osteoporosis screening and treatment as needed	receive 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.

Primary Outcome Measures

Name	Time	Method
The changes of Quality of life and quality adjusted life year	one year, two year, 3 year, four 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.
Institutionalilzation rate	one year, two year, 3 year, four year	To define if the Institutionalilzation rate would be changed after intervention
Intrinsic capacity	one year, two year, 3 year, four year	To define if the Intrinsic capacity would be changed after intervention

Secondary Outcome Measures

Name	Time	Method
Incidence of unexpected hospitalization	one year, two year, 3 year, four year	To define if the unexpected hospitalization would be changed after intervention
Incidence of fracture	one year, two year, 3 year, four year	To define if the incidence of fracture would be changed after intervention
Incidence of fall	one year, two year, 3 year, four year	To define if the fall frequency would be changed after intervention

Trial Locations

Locations (1)

National Taiwan University Hospital, Yunlin branch; 🇨🇳 Douliu, Yunlin County, Taiwan