NCT04835090

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

March 2, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

February 22, 2021

Last Update Submit

April 5, 2021

Conditions

Keywords

frailtytransitionpsychometric attributesfeasibilityscreeningcommunity-dwellingelderly

Outcome Measures

Primary Outcomes (5)

  • Change in Frailty Phenotype (FP)

    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)

    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)

    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

    handgrip strength measured via a dynamometer (in kilograms)

    This will be measured at baseline, three months and six months.

  • Change in Gait Speed

    5 meter usual gait speed (in seconds)

    This will be measured at baseline, three months and six months.

Secondary Outcomes (4)

  • Screening Time

    This will be measured at baseline.

  • Screening Completion

    This will be measured at baseline.

  • Change in Number of Hospitalization

    This will be measured at three months and six months.

  • Change in Number of Falls

    This will be measured at three months and six months.

Interventions

using three screening tools

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wei Gong Memorial Hospital

Toufen Township, 35159, Taiwan

RECRUITING

Related Publications (6)

  • Abbasi M, Khera S, Dabravolskaj J, Garrison M, King S. Identification of Frailty in Primary Care: Feasibility and Acceptability of Recommended Case Finding Tools Within a Primary Care Integrated Seniors' Program. Gerontol Geriatr Med. 2019 May 15;5:2333721419848153. doi: 10.1177/2333721419848153. eCollection 2019 Jan-Dec.

    PMID: 31192278BACKGROUND
  • Ambagtsheer RC, Thompson MQ, Archibald MM, Casey MG, Schultz TJ. Diagnostic test accuracy of self-reported screening instruments in identifying frailty in community-dwelling older people: A systematic review. Geriatr Gerontol Int. 2020 Jan;20(1):14-24. doi: 10.1111/ggi.13810. Epub 2019 Nov 14.

    PMID: 31729157BACKGROUND
  • Fukutomi E, Okumiya K, Wada T, Sakamoto R, Ishimoto Y, Kimura Y, Kasahara Y, Chen WL, Imai H, Fujisawa M, Otuka K, Matsubayashi K. Importance of cognitive assessment as part of the "Kihon Checklist" developed by the Japanese Ministry of Health, Labor and Welfare for prediction of frailty at a 2-year follow up. Geriatr Gerontol Int. 2013 Jul;13(3):654-62. doi: 10.1111/j.1447-0594.2012.00959.x. Epub 2012 Nov 22.

    PMID: 23170783BACKGROUND
  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PMID: 11253156BACKGROUND
  • 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.

    PMID: 19682112BACKGROUND
  • 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.

    PMID: 26927924BACKGROUND

MeSH Terms

Conditions

Frailty

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Hung-Ru Lin, PhD

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Ru Lin, PhD

CONTACT

Meei-Horng Yang, MSN

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Nursing & Dean of Academic Affairs

Study Record Dates

First Submitted

February 22, 2021

First Posted

April 8, 2021

Study Start

March 2, 2021

Primary Completion

September 1, 2021

Study Completion

November 1, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations