Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000192987
Ethics application status
Approved
Date submitted
12/02/2011
Date registered
18/02/2011
Date last updated
21/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Epidemiological profile of frail elderly receiving care in the Geriatric Clinic at a high complexity hospital
Scientific title
Assessment of frailty in elderly receiving care in the Geriatric Clinic at a high complexity hospital
Secondary ID [1] 253590 0
no secondary ID.
Universal Trial Number (UTN)
U1111-1119-4201
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The study attempted to evaluate frailty in nonagenarians, classifying elderly in frail, intermediate and not frail. 261145 0
Condition category
Condition code
Other 259302 259302 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Public Health 259320 259320 0 0
Epidemiology
Physical Medicine / Rehabilitation 259321 259321 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study attempted to describe the epidemiological profile of frail elderly. The study was performed over a period of three months. The assessment was performed in eleven visits to the Geriatric Clinic over this period, with a frequency of once a week aproximately. The evaluation was performed on one occasion only for each volunteer. The assessment duration for each volunteer was 10-15 minutes. Only the elderly included in the study were evaluated. The frailty evaluated was based on the measure of self-reported weight loss, weakness, measured by dynamometer, exhaustion, measured a questionnaire, slowness, measured by the time of walking 15 feet, and low physical activity level, measured by a questionnaire. Weight and height measurements were obtained at evaluation. History of falls and hospitalization was obtained at the moment of the evaluation by asking the individual. Information about diseases diagnosed, medications in use and measures of weight in the last year was obtained from the medical records of the patients from the moment of the assessment until one year ago.
Intervention code [1] 258012 0
Not applicable
Comparator / control treatment
none.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262115 0
Frailty by the presence of three or more positive results to the measures of wheight loss, weakness, exhaustion, slowness and low physical activity level. Weight loss was measured by a verbal questioning to the volunteer about weight loss in the past year, a afirmative answer was a positive result. Weakness was measured by a hand dynamometer, the lowest 20% (by gender, body mass index) measure was a positive result. Exhaustion was measured by two questions of the Center for Epidemiological Studies Depression Scale, individuals who answer 2 or 3 for each questions represent a positive result. Slowness was measured by the time spent to the volunteer performed a walk 15 feet, the lowest 20% (by gender, height) measure was a positive result. Low physical activity level was measured by the International Physical Activity Questionnaire, individuals with low physical activity level were considered vulnerable to frail.
Timepoint [1] 262115 0
moment of the evaluation.
Secondary outcome [1] 273192 0
Data collection of history of falls in the past year, hospitalization in the past year, diseases and medications in use obtained from self-report and medical records.
Timepoint [1] 273192 0
moment of the evaluation.

Eligibility
Key inclusion criteria
Were included individuals with ninety years or more, with independent gait with or without auxiliary devices of gait, such as walker or walking stick, and with cognitive capacity to understand the tests.
Minimum age
90 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria was being incapable to performance the test, because of a acute clinical condition at the moment of the evaluation for example.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment outside Australia
Country [1] 3176 0
Brazil
State/province [1] 3176 0

Funding & Sponsors
Funding source category [1] 258484 0
Self funded/Unfunded
Name [1] 258484 0
none
Country [1] 258484 0
Primary sponsor type
Individual
Name
Aline Aoki
Address
Rua Geolandia 826 Vila Medeiros Sao Paulo SP CEP 02217000
Country
Brazil
Secondary sponsor category [1] 257625 0
None
Name [1] 257625 0
none
Address [1] 257625 0
none
Country [1] 257625 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260460 0
Comissao de Etica para Analise de Projetos de Pesquisa do HCFMUSP
Ethics committee address [1] 260460 0
Ethics committee country [1] 260460 0
Brazil
Date submitted for ethics approval [1] 260460 0
Approval date [1] 260460 0
Ethics approval number [1] 260460 0

Summary
Brief summary
This study attempted to evaluate frailty in nonagenarians receiving care in Geraitric Clinic. The assessment was performed based on the measure of weigth loss, weakness, exhaustion, slowness and low physical activity level. Those with three or more positive results were considered frail, those with no positive results were considered not frail, and those with one or two positive results were intermediate.
Trial website
none
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32198 0
Address 32198 0
Country 32198 0
Phone 32198 0
Fax 32198 0
Email 32198 0
Contact person for public queries
Name 15445 0
Aline Aoki
Address 15445 0
Rua Geolandia 826 Vila Medeiros Sao Paulo SP CEP 02217000
Country 15445 0
Brazil
Phone 15445 0
+ 55 11 99211676
Fax 15445 0
Email 15445 0
[email protected]
Contact person for scientific queries
Name 6373 0
Aline Aoki
Address 6373 0
Rua Geolandia 826 Vila Medeiros Sao Paulo SP CEP 02217000
Country 6373 0
Brazil
Phone 6373 0
+ 55 11 99211676
Fax 6373 0
Email 6373 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.