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

April 11, 2024 updated by: National Taiwan University Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
    • Yunlin County
      • Douliu, Yunlin County, Taiwan
        • Recruiting
        • National Taiwan University Hospital, Yunlin branch
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age≥ 50 old and lived in the community

Exclusion Criteria:

  • Life expectancy less than two years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Osteoporosis screening and treatment as needed
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.
Placebo Comparator: 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.
Behavioral: Osteoporosis screening and treatment as needed
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.
Experimental: Multi-component integrated intervention
Introduce integrated services of health education, nutrition, rehabilitation, pharmaceutical care, and other multi-specialties to assist study participants with health promotion
Behavioral: Osteoporosis screening and treatment as needed
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.
Behavioral: Sarcopenia
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.
Behavioral: Exercise
TheraBand (resistance band) was utilized as the exercise tool within the community. T
Dietary supplement: Nutrition
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.
Behavioral: Pharmaceutical care
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of fall
Time Frame: one year, two year, 3 year, four year
To define if the fall frequency would be changed after intervention
one year, two year, 3 year, four year
Incidence of fracture
Time Frame: one year, two year, 3 year, four year
To define if the incidence of fracture would be changed after intervention
one year, two year, 3 year, four year
Incidence of unexpected hospitalization
Time Frame: one year, two year, 3 year, four year
To define if the unexpected hospitalization would be changed after intervention
one year, two year, 3 year, four year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of mortality
Time Frame: one year, two year, 3 year, four year
To define if the Incidence of mortality would be changed after intervention
one year, two year, 3 year, four year
Changes of drug related problems
Time Frame: one year, two year, 3 year, four year
Under the assumption of the intervention of pharmaceutical care in the multi-component group can improve the DRPs of the elderly, we also measured the changes of drug number, anticholinergic burden and adherence (using the Adherence to Refills and Medications Scale).
one year, two year, 3 year, four year
Phyiscal performance
Time Frame: one year, two years
Changes of muscle strength, body composition, physical performance, activites of daily living
one year, two years
Sarcopenia related outcomes
Time Frame: one year, two years
We follow sarcopenia diagnosis rate, treatment rate, changes of muscle mass, fat, and muscle-fat index
one year, two years
Osteoporosis related outcomes
Time Frame: one year, two years
We follow osteoporosis diagnosis rate, treatment rate, adherence to osteoporosis treatment, and changes of bone mineral density
one year, two years
Mental health
Time Frame: one year, two years
We use Geriatric Depression Scale and Chinese Happiness Inventory to measure depression and happiness
one year, two years
Nutrition related outcomes
Time Frame: one year, two years
Changes in protein intake, dietary/caloric intake, nutritional status
one year, two years
Cognition
Time Frame: one year, two years
Changes in MMSE
one year, two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Health Research Institutes, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 11, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (Actual)

November 2, 2021

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202106076RIND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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