Clinical trial NCT05883423: Application of Frailty Prevention Care Management Program of Community Elderly Adults
Official title: Application of Frailty Prevention Care Management Program on Frailty and Health Function of Community Elderly Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty
Keywords: elderly adults
frailty prevention care management programs
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study first explored the relationship between basic demographic variables, frailty and health function of community-based adults and elderly. Promote and explore the effect of the Frailty Prevention Care Management Program (FPCMP-Old Age) on the frailty and health function of the elderly in the community.

The elderly in the long-term care community bases in the central and southern regions were selected as the object of acceptance. The study design is divided into two years(Two phases) study, the first phase is to develop a 12-week frailty prevention care management plan (FPCMP-Old Age). The second stage is to introduce FPCMP-Old Age to carry out a pilot study in the south-central community. A total of 70 cases were accepted in the experimental group and the control group. This study was divided into two groups, which were grouped by convenient sampling. The experimental group underwent the FPCMP-Old Ag program; the control group only maintained the original site to delay disability and dementia activities. In this study, pre-intervention, post-intervention, and four-week follow-up were conducted, and three questionnaires were evaluated. Each time it was estimated to spend 30 minutes for each answer, the activity lasted for 12 weeks. The execution period this time is from January 1, 2023 to December 30, 2024, but the time for accepting cases is from June 1, 2023 to December 31, 2023. There are four research tools in this study, namely: demographic variables, chronic disease and health problem scale, frailty detection tool (TFI-T), health function (refer to the 2016 recommendation of the Ministry of Education and Sports Administration for the fitness of the elderly group Test items, testing the subject's body composition, upper and lower limb muscle strength, upper and lower limb flexibility, cardiorespiratory endurance, dynamic and static balance) and nutritional status (mini nutritional assessment) and other tools. Data were collected in triplicate, and generalized estimating equations were used to analyze whether there were differences in interaction effects between groups, within groups, and time.

The Frailty Prevention Care Management Program (FPCMP-Old Age) can help community-based adults and older adults reduce frailty and improve health function.

Detailed description: Background ：The elderly are a high-risk group for developing frailty symptoms. The prevalence of frailty ranges from 16% for those over 65 years of age to 52% for those over 85 years of age, and it increases proportionally with age. Frailty is not a disease. It represents the cumulative functional degeneration of various systems. It is a sub-healthy state or a stage before disability. Some elderly people have different degrees of frailty. In mild cases, there may be no clinical symptoms. Interference part of life; more severe cases may lead to disability or disease.

Objective：This study first explored the relationship between basic demographic variables, frailty and health function of community-based adults and elderly. Promote and explore the effect of the Frailty Prevention Care Management Program (FPCMP-Old Age) on the frailty and health function of the elderly in the community.

Methods：The elderly in the long-term care community bases in the central and southern regions were selected as the object of acceptance. The study design is divided into two years(Two phases) study, the first phase is to develop a 12-week frailty prevention care management plan (FPCMP-Old Age). The second stage is to introduce FPCMP-Old Age to carry out a pilot study in the south-central community. A total of 70 cases were accepted in the experimental group and the control group. This study was divided into two groups, which were grouped by convenient sampling. The experimental group underwent the FPCMP-Old Ag program; the control group only maintained the original site to delay disability and dementia activities. In this study, pre-intervention, post-intervention, and four-week follow-up were conducted, and three questionnaires were evaluated. Each time it was estimated to spend 30 minutes for each answer, the activity lasted for 12 weeks. The execution period this time is from January 1, 2023 to December 30, 2024, but the time for accepting cases is from June 1, 2023 to December 31, 2023. There are four research tools in this study, namely: demographic variables, chronic disease and health problem scale, frailty detection tool (TFI-T), health function (refer to the 2016 recommendation of the Ministry of Education and Sports Administration for the fitness of the elderly group Test items, testing the subject's body composition, upper and lower limb muscle strength, upper and lower limb flexibility, cardiorespiratory endurance, dynamic and static balance) and nutritional status (mini nutritional assessment) and other tools. Data were collected in triplicate, and generalized estimating equations were used to analyze whether there were differences in interaction effects between groups, within groups, and time.

Conclusions/practical application： The Frailty Prevention Care Management Program (FPCMP-Old Age) can help community-based adults and older adults reduce frailty and improve health function.

Eligibility criteria: Inclusion Criteria:

* Community elders over 60 years old; able to communicate in Mandarin and Taiwanese and voluntarily participate in this course

Exclusion Criteria:

* Those who suffer from severe chronic diseases (such as heart disease, end-stage kidney disease, cancer) or severe illness, etc., and are unable to exercise
* Those who have severe visual and hearing impairments or use assistive devices without communication barriers
* Suffering from severe bone and joint diseases (for example: severe osteoporosis, severe knee or shoulder joint degeneration)
* Arrhythmia that requires drug treatment or a cardiac pacemaker
* Those with severe cognitive impairment.

Primary outcomes:
measure: The Taiwanese version of Tilburg frailty indicator(TFI-T)
timeFrame: It takes 5 minutes to fill out the questionnaire
measure: Chronic Disease and Health Problems Scale
timeFrame: It takes 5 minutes to fill out the questionnaire
measure: Health Function
timeFrame: It takes 15 minutes to test health function
measure: Nutritional Assessment
timeFrame: It takes 5 minutes to fill out the questionnaire
Secondary outcomes:
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Taiwan
Study officials:
affiliation: Chang Gung Medical Foundation
name: Chia-Hui Lin, PhD
role: STUDY_DIRECTOR
References:
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citation: Ha J, Park YH. Effects of a Person-Centered Nursing Intervention for Frailty among Prefrail Community-Dwelling Older Adults. Int J Environ Res Public Health. 2020 Sep 13;17(18):6660. doi: 10.3390/ijerph17186660.
citation: McDermott AY, Mernitz H. Exercise and older patients: prescribing guidelines. Am Fam Physician. 2006 Aug 1;74(3):437-44.