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Comparison of Three Frailty Screening Tools

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ClinicalTrials.gov Identifier: NCT04835090
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
Wei Gong Memorial Hospital
Information provided by (Responsible Party):
Hung-Ru Lin, PhD, RN, National Taipei University of Nursing and Health Sciences

Study Description
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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.

Condition or disease Intervention/treatment
Frailty Other: screening test

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of the State Transition, Psychometric Attributes and Feasibility of Three Frailty Screening Tools in Community-dwelling Elderly
Actual Study Start Date : March 2, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : November 2021
Groups and Cohorts
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Intervention Details:
  • Other: screening test
    using three screening tools

Outcome Measures
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Primary Outcome Measures :
  1. Change in Frailty Phenotype (FP) [ Time Frame: This will be measured at baseline, three months and six months. ]
    The FP measurement tool consists five items (yes/no) which includes handgrip strength measured via a dynamometer (in kilograms), self-reported weight loss, self-reported exhaustion, 5 meter usual gait speed (in seconds), and physical activity level measured by the Taiwan International Physical Activity Questionnaire Short Form (Taiwanese version of the IPAQ), which was used to calculate calorie consumption. The number of criteria (a 6-level ordinal variable ranging from 0 to 5) is categorized into a 3-level variable depicting robust (none of the criteria), pre-frail (one or two criteria) and frail (three or more criteria).

  2. Change in Study of Osteoporotic Fractures (SOF) [ Time Frame: This will be measured at baseline, three months and six months. ]
    The SOF consists three items (yes/no) which includes weight loss (unintentional); inability to rise from a chair 5 times without the use of arms; and reduced energy level. Frail status was defined as robust (none of components), prefrail (one component), and frail (two or more components).

  3. Change in Kihon Checklist (KCL) [ Time Frame: This will be measured at baseline, three months and six months. ]
    The KCL consists of 25 items (yes/no) divided into seven domains: physical strength, nutrition, eating, socialization, memory, mood; each domain is rated on a pass (0)/fail (1) basis, and the sum of all indices ranges from 0 (no frailty) to 25 (severe frailty); a higher score indicates worse functioning. Frailty status was defined as robust (0-3 scores), prefrail (4-7 scores), and frail (8 scores or more ).

  4. Change in Handgrip Strength [ Time Frame: This will be measured at baseline, three months and six months. ]
    handgrip strength measured via a dynamometer (in kilograms)

  5. Change in Gait Speed [ Time Frame: This will be measured at baseline, three months and six months. ]
    5 meter usual gait speed (in seconds)


Secondary Outcome Measures :
  1. Screening Time [ Time Frame: This will be measured at baseline. ]
    Use a stopwatch to record the time from the beginning to the end of each measurement tool at baseline . Units of measurement is minutes and seconds

  2. Screening Completion [ Time Frame: This will be measured at baseline. ]
    The screening completion rate is defined as completing the each tool for the frailty screening of the elderly in the community at baseline.

  3. Change in Number of Hospitalization [ Time Frame: This will be measured at three months and six months. ]
    occurence of hospitalization

  4. Change in Number of Falls [ Time Frame: This will be measured at three months and six months. ]
    occurence of falls


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04835090


Contacts
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Contact: Hung-Ru Lin, PhD 886-2-28227101 ext 2300 hungru@ntunhs.edu.tw
Contact: Meei-Horng Yang, MSN +886-37-676811 ext 88969 celinayang2014@gmail.com

Locations
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Taiwan
Wei Gong Memorial Hospital Recruiting
Toufen, Taiwan, 35159
Contact: Meei-Horng Yang, MSN    886-37-676811 ext 88969    celinayang2014@gmail.com   
Principal Investigator: Meei-Horng Yang, MSN         
Sponsors and Collaborators
National Taipei University of Nursing and Health Sciences
Wei Gong Memorial Hospital
Investigators
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Principal Investigator: Hung-Ru Lin, PhD National Taipei University of Nursing and Health Sciences
More Information
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Publications:

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Responsible Party: Hung-Ru Lin, PhD, RN, Professor, School of Nursing & Dean of Academic Affairs, National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier: NCT04835090    
Other Study ID Numbers: 200836
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hung-Ru Lin, PhD, RN, National Taipei University of Nursing and Health Sciences:
frailty
transition
psychometric attributes
feasibility
 screening
community-dwelling
elderly
Additional relevant MeSH terms:
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Frailty
Pathologic Processes