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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05104034
Enrollment
600
Registered
2021-11-02
Start date
2021-09-17
Completion date
2025-12-31
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Osteoporosis, Sarcopenia

Keywords

Osteoporosis, Sarcopenia, Quality of life, Intrinsic capacity, Frailty

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.

Interventions

BEHAVIORALOsteoporosis 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.

BEHAVIORALSarcopenia

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.

BEHAVIORALExercise

TheraBand (resistance band) was utilized as the exercise tool within the community. T

DIETARY_SUPPLEMENTNutrition

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.

BEHAVIORALPharmaceutical 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.

Sponsors

National Health Research Institutes, Taiwan
CollaboratorOTHER
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age≥ 50 old and lived in the community

Exclusion criteria

* Life expectancy less than two years

Design outcomes

Primary

MeasureTime frameDescription
Intrinsic capacityone year, two year, 3 year, four yearTo define if the Intrinsic capacity would be changed after intervention
Institutionalilzation rateone year, two year, 3 year, four yearTo define if the Institutionalilzation rate would be changed after intervention
The changes of Quality of life and quality adjusted life yearone year, two year, 3 year, four yearUsing 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.

Secondary

MeasureTime frameDescription
Incidence of fallone year, two year, 3 year, four yearTo define if the fall frequency would be changed after intervention
Incidence of fractureone year, two year, 3 year, four yearTo define if the incidence of fracture would be changed after intervention
Incidence of unexpected hospitalizationone year, two year, 3 year, four yearTo define if the unexpected hospitalization would be changed after intervention

Other

MeasureTime frameDescription
Nutrition related outcomesone year, two yearsChanges in protein intake, dietary/caloric intake, nutritional status
Incidence of mortalityone year, two year, 3 year, four yearTo define if the Incidence of mortality would be changed after intervention
Cognitionone year, two yearsChanges in MMSE
Changes of drug related problemsone year, two year, 3 year, four yearUnder 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).
Phyiscal performanceone year, two yearsChanges of muscle strength, body composition, physical performance, activites of daily living
Sarcopenia related outcomesone year, two yearsWe follow sarcopenia diagnosis rate, treatment rate, changes of muscle mass, fat, and muscle-fat index
Osteoporosis related outcomesone year, two yearsWe follow osteoporosis diagnosis rate, treatment rate, adherence to osteoporosis treatment, and changes of bone mineral density
Mental healthone year, two yearsWe use Geriatric Depression Scale and Chinese Happiness Inventory to measure depression and happiness

Countries

Taiwan

Contacts

Primary ContactShau-Huai Fu, Doctor
b90401045@gmail.com+886972655734
Backup ContactChen-Yu Wang, Doctor
valinawang0220@gmail.com+886952489782

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026