Clinical trial NCT05104034: 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
Overall status: RECRUITING
Phase: NA
Conditions: Osteoporosis
Sarcopenia
Frailty
Keywords: Osteoporosis
Sarcopenia
Quality of life
Intrinsic capacity
Frailty
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2021-11-02
Enrollment: 600
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Age≥ 50 old and lived in the community

Exclusion Criteria:

* Life expectancy less than two years

Primary outcomes:
measure: The changes of Quality of life and quality adjusted life year
timeFrame: one year, two year, 3 year, four year
measure: Intrinsic capacity
timeFrame: one year, two year, 3 year, four year
measure: Institutionalilzation rate
timeFrame: one year, two year, 3 year, four year
Secondary outcomes:
measure: Incidence of fall
timeFrame: one year, two year, 3 year, four year
measure: Incidence of fracture
timeFrame: one year, two year, 3 year, four year
measure: Incidence of unexpected hospitalization
timeFrame: one year, two year, 3 year, four year
Other outcomes:
measure: Incidence of mortality
timeFrame: one year, two year, 3 year, four year
measure: Changes of drug related problems
timeFrame: one year, two year, 3 year, four year
measure: Phyiscal performance
timeFrame: one year, two years
measure: Sarcopenia related outcomes
timeFrame: one year, two years
measure: Osteoporosis related outcomes
timeFrame: one year, two years
measure: Mental health
timeFrame: one year, two years
measure: Nutrition related outcomes
timeFrame: one year, two years
measure: Cognition
timeFrame: one year, two years
Locations:
city: Douliu
country: Taiwan
facility: National Taiwan University Hospital, Yunlin branch
state: Yunlin County
Study officials:
References: