- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03999047
Validation of the Screening Instrument: PRISMA-7 for Frailty Among Elderly Hospitalized Danes
June 24, 2019 updated by: Ellen Holm, Region Zealand
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
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
1050
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nykøbing Falster, Denmark, 4800
- Nykøbing Falster Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
75 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 6 months after PRISMA-7 screening
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Mortality
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6 months after PRISMA-7 screening
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Morbidity
Time Frame: 6 months after Prisma-7 screening
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Morbidity will be measured by registering Hospital admissions and use of general practitioner
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6 months after Prisma-7 screening
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of other health services
Time Frame: 6 months before PRISMA-7 screening
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Home help, rehabilitation services in the municipality
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6 months before PRISMA-7 screening
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Morbidity
Time Frame: 6 months after PRISMA-7 screening
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Morbidity will be measured by registering hospital admissions and use og general practitioner
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6 months after PRISMA-7 screening
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ellen A Holm, MD, Region Sjælland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kildemoes HW, Sorensen HT, Hallas J. The Danish National Prescription Registry. Scand J Public Health. 2011 Jul;39(7 Suppl):38-41. doi: 10.1177/1403494810394717.
- Lynge E, Sandegaard JL, Rebolj M. The Danish National Patient Register. Scand J Public Health. 2011 Jul;39(7 Suppl):30-3. doi: 10.1177/1403494811401482.
- Turner G, Clegg A; British Geriatrics Society; Age UK; Royal College of General Practioners. Best practice guidelines for the management of frailty: a British Geriatrics Society, Age UK and Royal College of General Practitioners report. Age Ageing. 2014 Nov;43(6):744-7. doi: 10.1093/ageing/afu138.
- Hebert R, Durand PJ, Dubuc N, Tourigny A; PRISMA Group. Frail elderly patients. New model for integrated service delivery. Can Fam Physician. 2003 Aug;49:992-7.
- Raiche M, Hebert R, Dubois MF. PRISMA-7: a case-finding tool to identify older adults with moderate to severe disabilities. Arch Gerontol Geriatr. 2008 Jul-Aug;47(1):9-18. doi: 10.1016/j.archger.2007.06.004. Epub 2007 Aug 27.
- Braun T, Gruneberg C, Thiel C. German translation, cross-cultural adaptation and diagnostic test accuracy of three frailty screening tools : PRISMA-7, FRAIL scale and Groningen Frailty Indicator. Z Gerontol Geriatr. 2018 Apr;51(3):282-292. doi: 10.1007/s00391-017-1295-2. Epub 2017 Aug 9.
- Hoogendijk EO, van der Horst HE, Deeg DJ, Frijters DH, Prins BA, Jansen AP, Nijpels G, van Hout HP. The identification of frail older adults in primary care: comparing the accuracy of five simple instruments. Age Ageing. 2013 Mar;42(2):262-5. doi: 10.1093/ageing/afs163. Epub 2012 Oct 28.
- Andersen JS, Olivarius Nde F, Krasnik A. The Danish National Health Service Register. Scand J Public Health. 2011 Jul;39(7 Suppl):34-7. doi: 10.1177/1403494810394718.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 16, 2019
Primary Completion (Anticipated)
December 31, 2019
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
June 16, 2019
First Submitted That Met QC Criteria
June 24, 2019
First Posted (Actual)
June 26, 2019
Study Record Updates
Last Update Posted (Actual)
June 26, 2019
Last Update Submitted That Met QC Criteria
June 24, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REG-070-2017
- 707462 (Other Identifier: Institute of Healtresearch)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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