NCT04166123

Brief Summary

The aims of this study are to validate the reliability and validity of Elderly Health Questionnaire in assessing frailty risk of community-dwelling older adults.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

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

Study Start

First participant enrolled

April 24, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

1.9 years

First QC Date

November 14, 2019

Last Update Submit

January 18, 2021

Conditions

Frailty

Keywords

frailtyolder adultsinstrumentcommunity

Outcome Measures

Primary Outcomes (1)

  • Elderly Health Questionnaire

    It is a self-report questionnaire about frailty and health conditions. Each item is scored 0 or 1, yielding a total of 0-70. The scores range from 0 (best performance) to 70 (worst performance).

    an average of 2-4 weeks between pretest and posttest (baseline, week 2-4)

Secondary Outcomes (6)

  • Taiwanese version of the Health Enhancement Lifestyle Profile (HELP-T)

    pretest (baseline)

  • WHOQOL-BREF Taiwan version

    pretest (baseline)

  • Short physical performance battery (SPPB)

    pretest (baseline)

  • Montreal Cognitive Assessment (MoCA)

    pretest (baseline)

  • Brief University of California at San Diego Performance-Based Skills Assessment (UPSA-B)

    pretest (baseline)

  • +1 more secondary outcomes

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

over 65 years old community-dwelling elderly

You may qualify if:

  • aged \> 65 years old
  • able to read
  • Clinical frailty scale ≦ 6

You may not qualify if:

  • diagnosed as dementia or schizophrenia
  • active cancer receiving treatment
  • terminal cancer patient
  • hospitalization in 1 month
  • with implantable device
  • couldn't follow the instructions
  • wheelchair bound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hui-Fen Mao, MS

    School of Occupational Therapy, College of Medicine, National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Fen Mao, MS

CONTACT

+886 2 33668178huifen02@gmail.com

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 18, 2019

Study Start

April 24, 2019

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

TW(1)