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

Primary Purpose

Osteoporosis, Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Osteoporosis and sarcopenia screening
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Osteoporosis, Sarcopenia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age≥ 50 old and lived in the community

Exclusion Criteria:

  • Life expectancy less than two years

Sites / Locations

  • National Taiwan University Hospital, Yunlin branchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Screening group

Multi-discipline intervention

Delayed intervention

Arm Description

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.

Introduce integrated services of health education, nutrition, rehabilitation, medication evaluation and other multi-specialties to assist study participants with health promotion

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.

Outcomes

Primary Outcome Measures

Osteoporosis diagnosis rate
To define if the osteoporosis diagnosis rate would be changed

Secondary Outcome Measures

Osteoporosis treatment rate
To define if the osteoporosis treatment rate would be changed
Sarcopenia diagnosis rate
To define if the Sarcopenia diagnosis rate would be changed
Incidence of fall
To define if the fall frequency would be changed

Full Information

First Posted
October 11, 2021
Last Updated
October 22, 2021
Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05104034
Brief Title
Comprehensive Risk Assessment and Prevention Plan of Osteoporosis and Sarcopenia for the Elderly Participating in Community-based Long-term Care Services
Official Title
Comprehensive Risk Assessment and Prevention Plan of Osteoporosis and Sarcopenia for the Elderly Participating in Community-based Long-term Care Services
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2021 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this project is: Provide the epidemiological data of the prevalence, incidence, and risk factors of osteoporosis and sarcopenia among the elderly in rural areas. 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 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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Sarcopenia
Keywords
Osteoporosis, Sarcopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Screening group
Arm Type
Experimental
Arm Description
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.
Arm Title
Multi-discipline intervention
Arm Type
Experimental
Arm Description
Introduce integrated services of health education, nutrition, rehabilitation, medication evaluation and other multi-specialties to assist study participants with health promotion
Arm Title
Delayed intervention
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Osteoporosis and sarcopenia screening
Intervention Description
Use DXA, BIA, and questionnaire to screen the community elderly
Primary Outcome Measure Information:
Title
Osteoporosis diagnosis rate
Description
To define if the osteoporosis diagnosis rate would be changed
Time Frame
one year
Secondary Outcome Measure Information:
Title
Osteoporosis treatment rate
Description
To define if the osteoporosis treatment rate would be changed
Time Frame
one year
Title
Sarcopenia diagnosis rate
Description
To define if the Sarcopenia diagnosis rate would be changed
Time Frame
one year
Title
Incidence of fall
Description
To define if the fall frequency would be changed
Time Frame
two year
Other Pre-specified Outcome Measures:
Title
Incidence of fracture
Description
To define if the Incidence of fracture would be changed
Time Frame
four year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age≥ 50 old and lived in the community Exclusion Criteria: Life expectancy less than two years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shau-Huai Fu, Doctor
Phone
+886972655734
Email
b90401045@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chen-Yu Wang, Doctor
Phone
+886952489782
Email
valinawang0220@gmail.com
Facility Information:
Facility Name
National Taiwan University Hospital, Yunlin branch
City
Douliu
State/Province
Yunlin County
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shau-Huai Fu, Doctor
Phone
+886972655734
Email
b90401045@gmail.com
First Name & Middle Initial & Last Name & Degree
Chen-Yu Wang, Doctor
Phone
+886952489782
Email
valinawang0220@gmail.com

12. IPD Sharing Statement

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

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