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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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