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Frailty SyndromeNCT03999047

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

An observational study of Frailty Syndrome, run by Region Zealand at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Frailty Syndrome
What is being tested?
PRISMA score
How many people
1,050 participants
Where
1 siteDenmark
Study dates
16 Jun 2019to 31 Dec 2022
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Nykøbing Falster Hospital

    Nykøbing Falster, 4800

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
PRISMA score
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRISMA scoreDiagnostic test

    Screening for frailty using PRISMA-7

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Mortality

    Measured: 6 months after PRISMA-7 screening

  2. Morbidity

    Morbidity will be measured by registering Hospital admissions and use of general practitioner

    Measured: 6 months after Prisma-7 screening

Secondary outcomes (2)

  1. Use of other health services

    Home help, rehabilitation services in the municipality

    Measured: 6 months before PRISMA-7 screening

  2. Morbidity

    Morbidity will be measured by registering hospital admissions and use og general practitioner

    Measured: 6 months after PRISMA-7 screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2019
  2. Study start16 Jun 2019
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,050 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03999047
Sponsor's protocol ID
REG-070-2017
Other IDs
707462
Status last verified
Jun 2019
First submitted
16 Jun 2019
Last updated
26 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25336440

  • 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.

    PubMed 12943358

  • 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.

    PubMed 17723247

  • 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.

    PubMed 28795247

  • 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.

    PubMed 23108163

  • 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.

    PubMed 21775347

  • 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.

    PubMed 21775348

  • 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.

    PubMed 21775349

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty Syndrome, run by Region Zealand at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 6 months after PRISMA-7 screening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03999047, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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