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Trial record 3 of 4 for:    21775347 [PUBMED-IDS]

Validation of the Screening Instrument: PRISMA-7 for Frailty Among Elderly Hospitalized Danes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03999047
Recruitment Status : Active, not recruiting
First Posted : June 26, 2019
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Ellen Holm, Region Zealand

Brief Summary:
The questionnaire PRISMA-7 was originally developed to assess frailty in community dwelling adults. The questionnaire was translated into the Danish language. This instrument was used to screen for frailty among elderly patients (75+) sent home from Nykøbing Falster Hospital after a hospital admission during the period 31. May 2017 until December 31st, 2018. PRISMA results were used to categorize each individula as frail or non-frail. The register of PRISMA results was merged with national registers on use of health serviced in order to investigate if increasing PRISMA score was associated with increasing use of health services.

Condition or disease Intervention/treatment
Frailty Syndrome Diagnostic Test: PRISMA score

Detailed Description:
Data from PRISMA scores were registered in an EasyTrial database. This database is recognized by the regional health authorities as a safe system to store individual health data. All use of the EasyTRial database is logged. The merging of data from the local EasyTRial database with data from national registries on use of health services and on mortality was permitted by the Danish National Health Data protection authorities.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1050 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Validation of the Screening Instrument: PRISMA-7 for Frailty Among +75 Year Old Danes Still in Need of Physical Training When They Are Sent Home After a Hospital Stay
Actual Study Start Date : June 16, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: PRISMA score
    Screening for frailty using PRISMA-7


Primary Outcome Measures :
  1. Mortality [ Time Frame: 6 months after PRISMA-7 screening ]
    Mortality

  2. Morbidity [ Time Frame: 6 months after Prisma-7 screening ]
    Morbidity will be measured by registering Hospital admissions and use of general practitioner


Secondary Outcome Measures :
  1. Use of other health services [ Time Frame: 6 months before PRISMA-7 screening ]
    Home help, rehabilitation services in the municipality

  2. Morbidity [ Time Frame: 6 months after PRISMA-7 screening ]
    Morbidity will be measured by registering hospital admissions and use og general practitioner



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Persons 75 years old og older who have been staying in hospital and are in need physical rehabilitation in the municipality when they are sent home from hospital.
Criteria

Inclusion Criteria:

  • 75 years old persons being returned from hospital after a hospital admission and in need of further physical rehabilitation in the community

Exclusion Criteria:

Not able to give informed consent or if necessary not having a relative that can give informed consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03999047


Locations
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Denmark
Nykøbing Falster Hospital
Nykøbing Falster, Denmark, 4800
Sponsors and Collaborators
Region Zealand
University of Southern Denmark
Investigators
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Principal Investigator: Ellen A Holm, MD Region Sjælland
  Study Documents (Full-Text)

Documents provided by Ellen Holm, Region Zealand:

Publications:

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Responsible Party: Ellen Holm, Consultant, Region Zealand
ClinicalTrials.gov Identifier: NCT03999047     History of Changes
Other Study ID Numbers: REG-070-2017
707462 ( Other Identifier: Institute of Healtresearch )
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Frailty
Pathologic Processes