Comparison of Three Frailty Screening Tools

April 5, 2021 updated by: Hung-Ru Lin, PhD, RN, National Taipei University of Nursing and Health Sciences

Comparison of the State Transition, Psychometric Attributes and Feasibility of Three Frailty Screening Tools in Community-dwelling Elderly

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Toufen, Taiwan, 35159
        • Recruiting
        • Wei Gong Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Meei-Horng Yang, MSN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
This will be measured at baseline.
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.
This will be measured at baseline.
Change in Number of Hospitalization
Time Frame: This will be measured at three months and six months.
occurence of hospitalization
This will be measured at three months and six months.
Change in Number of Falls
Time Frame: This will be measured at three months and six months.
occurence of falls
This will be measured at three months and six months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taipei University of Nursing and Health Sciences

Collaborators

Wei Gong Memorial Hospital

Investigators

  • Principal Investigator: Hung-Ru Lin, PhD, National Taipei University of Nursing and Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

April 5, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200836

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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