Comparison of Three Frailty Screening Tools

NCT ID: NCT04835090

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-02
• Study Completion Date: 2021-11-30

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.

Conditions

Frailty

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

screening test

using three screening tools

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wei Gong Memorial Hospital

OTHER

Sponsor Role: collaborator

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Hung-Ru Lin, PhD, RN

Professor, School of Nursing & Dean of Academic Affairs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hung-Ru Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taipei University of Nursing and Health Sciences

Locations

Wei Gong Memorial Hospital

Toufen Township, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hung-Ru Lin, PhD

Role: CONTACT

hungru@ntunhs.edu.tw

886-2-28227101 ext. 2300

Meei-Horng Yang, MSN

Role: CONTACT

celinayang2014@gmail.com

+886-37-676811 ext. 88969

Facility Contacts

Meei-Horng Yang, MSN

Role: primary

celinayang2014@gmail.com

886-37-676811 ext. 88969

References

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Reference Type: BACKGROUND

PMID: 31192278 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 31729157 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 23170783 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 11253156 (View on PubMed)

Kiely DK, Cupples LA, Lipsitz LA. Validation and comparison of two frailty indexes: The MOBILIZE Boston Study. J Am Geriatr Soc. 2009 Sep;57(9):1532-9. doi: 10.1111/j.1532-5415.2009.02394.x. Epub 2009 Jul 21.

Reference Type: BACKGROUND

PMID: 19682112 (View on PubMed)

Sutton JL, Gould RL, Daley S, Coulson MC, Ward EV, Butler AM, Nunn SP, Howard RJ. Psychometric properties of multicomponent tools designed to assess frailty in older adults: A systematic review. BMC Geriatr. 2016 Feb 29;16:55. doi: 10.1186/s12877-016-0225-2.

Reference Type: BACKGROUND

PMID: 26927924 (View on PubMed)

Other Identifiers

200836

Identifier Type: -

Identifier Source: org_study_id