Clinical trial NCT04835090: Comparison of Three Frailty Screening Tools
Official title: Comparison of the State Transition, Psychometric Attributes and Feasibility of Three Frailty Screening Tools in Community-dwelling Elderly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frailty
Keywords: frailty
transition
psychometric attributes
feasibility
screening
community-dwelling
elderly
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Wei Gong Memorial Hospital
First posted: 2021-04-08
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community-dwelling elderly aged 65 or older referral by the personnel in outpatient department in a hospital, community care centers, activity centers, health centers, C tiers of community care service system, health stations, love angel stations, long-term care centers, and community development associations.

Brief summary: The financial health care and social impact of the frailty of the elderly is an important issue for preventive health care in various countries around the world. The Taiwan government launched the long-term care 10-year plan version 2.0 in 2017 and expanded service target with older people with frailty as a service need. There is no consensus on the definition of frailty. However, there are many existing frailty screening instruments. It is very important to choose accurate and simple and rapid tools for screening to reduce the extra medical costs caused by negative outcomes of frailty. The primary purpose of this study is to understand the transition changes of the elderly in the community during the six months of frail state (robust, pre-frail, frail), and examine the validity of the frailty, physical function (handgrip strength, walking speed) to predict negative outcomes (falls, institutionalization/hospitalization), and will be compared with the results of three frailty screening tools. The secondary purpose is to compare the feasibility (screening time, screening completion rate, equipment and space) of the three tools for the frailty screening of the elderly in the community.

Detailed description: This is a prospective study with six month follow-up among community-dwelling elderly aged 65 or older. Agreement between instruments, Frail state transition changes, feasibility, internal consistency, concurrent and predictive validity, convergent validity of instruments will be evaluated and compared. The participants' recruitment strategies will be through referrals by the personnel in outpatient department in a hospital, community care centers, health centers, C tiers of community care service system, love angel stations etc. We focused on three available instruments based on literature review and expert opinions for community-dwelling elderly care: Kihon Checklist (KCL), Study of Osteoporotic Fractures (SOF), and frailty phenotype (FP) screening tools. Using G-power3.1 for sample size estimation, 80 subjects will be needed. Based on the estimated loss rate is 30%, so 110 participants need to be recruited.

The screening sequence of this research will carry out with the Randomization block. There are six sequence combinations with three frailty screening tools. The researcher read the questionnaire one by one item, and then will fill the participants' answers into the data collection sheets. The physical function test is performed by the researcher.

This study was approved by the institutional Review Board. All participants will be asked to complete written informed consent. The statistical method adopts multivariate repeated measure analysis to detect the transition of frailty state. The area under the curve (AUC) will be used to examine the predictive ability on body function (grip strength, walking speed) and negative outcomes (falls, hospitalization) of the three frailty screening tools.

The anticipated benefits of this study will include (1) clinical practice: provide the screening time, completion rate, reliability and validity of the frailty screening tools to clinical health care professionals with reference to the selection of frailty screening tools for the community-dwelling elderly. Predicting the cut-off point of screening for falls or institutionalization/hospitalization of elderly people in the community can be used in nursing clinical practice to explain the screening results and risk assessment of falls and hospitalization to patients to prevent or delay the frailty progress. (2) academic research: provide a six-month observation of the changes in the frailty status of the elderly in the community in Taiwan, increase the understanding of the frailty transition of the elderly in the community, and identify frailty screening tools that have better prediction of physical functions and negative results. (3) National development: The results of this study are provided to the government as a reference for optimizing Taiwan's long-term care 2.0 policy formulation.

Eligibility criteria: Inclusion Criteria:

1. Age of 65 years and older with community-dwelling in Taoyuan and Hsinchu city, Miaoli county
2. Communicate with Mandarin, Taiwanese, or Hakka
3. Agreement to participant the frailty screening three times within half a year after explanation, and have signed an informed consent.

Exclusion Criteria:

1. Living in a hospital or nursing home.
2. Dementia.
3. Bedridden or terminal illness.
4. Taking drugs for Alzheimer's disease or antidepressant drugs.
5. Stroke or upper or lower limb surgery in the past three months.

Primary outcomes:
measure: Change in Frailty Phenotype (FP)
timeFrame: This will be measured at baseline, three months and six months.
measure: Change in Study of Osteoporotic Fractures (SOF)
timeFrame: This will be measured at baseline, three months and six months.
measure: Change in Kihon Checklist (KCL)
timeFrame: This will be measured at baseline, three months and six months.
measure: Change in Handgrip Strength
timeFrame: This will be measured at baseline, three months and six months.
measure: Change in Gait Speed
timeFrame: This will be measured at baseline, three months and six months.
Secondary outcomes:
measure: Screening Time
timeFrame: This will be measured at baseline.
measure: Screening Completion
timeFrame: This will be measured at baseline.
measure: Change in Number of Hospitalization
timeFrame: This will be measured at three months and six months.
measure: Change in Number of Falls
timeFrame: This will be measured at three months and six months.
Other outcomes:
Locations:
city: Toufen
country: Taiwan
facility: Wei Gong Memorial Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Hung-Ru Lin, PhD
role: PRINCIPAL_INVESTIGATOR
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