NCT04650789

Brief Summary

To investigate the prevalence of Frailty in community older residents.

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
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 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

Study Start

First participant enrolled

January 1, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 3, 2020

Status Verified

May 1, 2020

Enrollment Period

4 years

First QC Date

August 24, 2020

Last Update Submit

November 24, 2020

Conditions

Frailty

Keywords

FrailtyLongitudinal cohort studyprevalence

Outcome Measures

Primary Outcomes (1)

  • The level of frailty

    1. Unexpected significant weight loss（\>5%). 2. Decreased strength: male grip strength ≤25 kg and female grip strength ≤18 kg 3. Reduced physical activity in the last month. 4. Slow walking speed is less than or equal to 0.8 m/s. 5. How tired you feel for the last month? The frailty period was defined as ≥3 items, early frailty was defined as 1-2 items, and non-frailty was defined as 0 items.

    baseline

Secondary Outcomes (5)

  • Clock Drawing Test

    baseline

  • Mini-Mental State Examination (MMSE)

    baseline

  • Skeletal muscle mass index (SMI)

    baseline

  • Markers of frailty

    baseline

  • Routine inspection

    baseline

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Cluster random sampling was used in urban and rural areas of Shanghai

You may qualify if:

  • more than 65 years old
  • Permanent residence in Shanghai and long-term residence in the community implemented by this project (more than five years)
  • Be willing to and be able to join in the study and signed Informed consent.

You may not qualify if:

  • Excluding the patients whose physical function is affected by diseases or disabilities such as stroke, Parkinson's disease, tumor, fracture, etc.
  • Excluding schizophrenia, depression, anxiety and other mental diseases and dependent on drug control.
  • If they were unable to complete the study survey.
  • Unwilling to join in the study and don't sign Informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Geriatric Institute of Chinese Medicine

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chuan Chen

    Shanghai Geriatric Institute of Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuan Chen

CONTACT

86-21-64720010ch9453@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2020

First Posted

December 3, 2020

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

December 3, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)