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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05104034
• Other study ID #: 202106076RIND
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: National Taiwan University Hospital
• Contact: Shau-Huai Fu, Doctor
• Phone: +886972655734
• Email: b90401045[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Age= 50 old and lived in the community

Exclusion Criteria:

• Life expectancy less than two years

Related Conditions & MeSH terms

• Frailty
• Osteoporosis
• Sarcopenia

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, Yunlin branch	Douliu	Yunlin County

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of mortality	To define if the Incidence of mortality would be changed after intervention	one year, two year, 3 year, four year
Other	Changes of drug related problems	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
Other	Phyiscal performance	Changes of muscle strength, body composition, physical performance, activites of daily living	one year, two years
Other	Sarcopenia related outcomes	We follow sarcopenia diagnosis rate, treatment rate, changes of muscle mass, fat, and muscle-fat index	one year, two years
Other	Osteoporosis related outcomes	We follow osteoporosis diagnosis rate, treatment rate, adherence to osteoporosis treatment, and changes of bone mineral density	one year, two years
Other	Mental health	We use Geriatric Depression Scale and Chinese Happiness Inventory to measure depression and happiness	one year, two years
Other	Nutrition related outcomes	Changes in protein intake, dietary/caloric intake, nutritional status	one year, two years
Other	Cognition	Changes in MMSE	one year, two years
Primary	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
Primary	Intrinsic capacity	To define if the Intrinsic capacity would be changed after intervention	one year, two year, 3 year, four year
Primary	Institutionalilzation rate	To define if the Institutionalilzation rate would be changed after intervention	one year, two year, 3 year, four year
Secondary	Incidence of fall	To define if the fall frequency would be changed after intervention	one year, two year, 3 year, four year
Secondary	Incidence of fracture	To define if the incidence of fracture would be changed after intervention	one year, two year, 3 year, four year
Secondary	Incidence of unexpected hospitalization	To define if the unexpected hospitalization would be changed after intervention	one year, two year, 3 year, four year