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Frail Elderly SyndromeIndiRAINCT03139162

Development of Clinical Indicators From the Swiss RAI-HC

An observational study of Frail Elderly Syndrome, run by School of Health Sciences Geneva.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The project aims at deriving frailty (FI) and complexity (CI) indices from data collected with the Resident Instrument Assessment - Home Care adapted for Switzerland (RAI-HC). Data were collected in 2015 by trained nurses in clinical routine with the primary purposes of health state assessment and individual home care… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Frail Elderly Syndrome
What is being tested?
Swiss RAI-HC assessment
How many people
10,000 participants
Where
No sites listed yet
Study dates
1 Jan 2015to 11 Apr 2023
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adult applicants for home care services provided by imad (Geneva, Switzerland) who received a first RAI-HC assessment in 2015 for routine care planning purposes

Who may be able to join

  • Men and women aged 18 or older who were assessed in 2015 with the Swiss RAI-HC in clinical routine for care planning by the Geneva Institution for Home care and Assistance (imad) in Geneva, Switzerland

Who cannot join

  • Men and women aged 17 or younger and/or who did not receive a full RAI-HC assessment in 2015

About this study

Official title: Development of Frailty and Complexity Indices From Data Collected With Resident Assessment Instrument - Home Care Adapted for Switzerland

The project aims at deriving frailty (FI) and complexity (CI) indices from data collected with the Resident Instrument Assessment - Home Care adapted for Switzerland (RAI-HC). Data were collected in 2015 by trained nurses in clinical routine with the primary purposes of health state assessment and individual home care planning. The study consists in a retrospective secondary analysis of health data from the Minimal Data Set (MDS), used to derive frailty and complexity indices according to published definitions and guidelines for index derivation. The analysis further aims at estimating the predictive power of these indices on undesirable health outcomes (falls, hospitalizations and deaths). The goal is to provide home care institutions and nurses valid algorithms to compute useful clinical indicators without additional assessment that the one routinely done with the RAI-HC.

Being tested
Swiss RAI-HC assessment
Keywords
Home Care Services, Aging, Frailty, Complexity, Nursing
Medical subject headings
Frailty

What participants receive

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

  • Swiss RAI-HC assessmentOther

    RAI-HC assessments done by trained nurses in clinical routine

What is being measured

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

  1. Frailty Index

    Index with a value ranging from 0 to 100, computed as the sum of health deficits recorded with the RAI-HC MDS divided by the number of deficits considered

    Measured: 1 year

  2. Complexity Index

    Index with a value ranging from 0 to 100, computed as the sum of complexity items recorded with the RAI-HC MDS divided by the number of items considered

    Measured: 1 year

Secondary outcomes (3)

  1. Falls

    Falls recorded by means of follow-up RAI-HC assessments

    Measured: 6 months on average

  2. Hospitalizations

    Hospitalizations recorded by means of follow-up RAI-HC assessments

    Measured: 6 months on average

  3. Mortality

    Deceased (yes/no); collected through administrative records

    Measured: through study completion, an average of 5 year

Timeline

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

  1. First posted3 May 2017
  2. Study start1 Jan 2015
  3. Primary completion31 Dec 2015
  4. Study completion11 Apr 2023

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
Retrospective
Enrolment
10,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03139162
Sponsor's protocol ID
74217
Acronym
IndiRAI
Status last verified
Oct 2022
First submitted
24 Apr 2017
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The coded datasets supporting the findings of this study are not publicly available for they belong to imad and are not the property of the authors of the study. The data analyzed for the study could be made available from the authors upon reasonable request and with prior agreement by imad.

Publications

  • Hubbard RE, Peel NM, Samanta M, Gray LC, Fries BE, Mitnitski A, Rockwood K. Derivation of a frailty index from the interRAI acute care instrument. BMC Geriatr. 2015 Mar 18;15:27. doi: 10.1186/s12877-015-0026-z.

    PubMed 25887105

  • Loeb DF, Binswanger IA, Candrian C, Bayliss EA. Primary care physician insights into a typology of the complex patient in primary care. Ann Fam Med. 2015 Sep;13(5):451-5. doi: 10.1370/afm.1840.

    PubMed 26371266

  • Morris JN, Fries BE, Steel K, Ikegami N, Bernabei R, Carpenter GI, Gilgen R, Hirdes JP, Topinkova E. Comprehensive clinical assessment in community setting: applicability of the MDS-HC. J Am Geriatr Soc. 1997 Aug;45(8):1017-24. doi: 10.1111/j.1532-5415.1997.tb02975.x.

    PubMed 9256857

  • Armstrong JJ, Stolee P, Hirdes JP, Poss JW. Examining three frailty conceptualizations in their ability to predict negative outcomes for home-care clients. Age Ageing. 2010 Nov;39(6):755-8. doi: 10.1093/ageing/afq121. Epub 2010 Sep 21. No abstract available.

    PubMed 20858672

  • Ludwig C, Busnel C. Derivation of a frailty index from the resident assessment instrument - home care adapted for Switzerland: a study based on retrospective data analysis. BMC Geriatr. 2017 Sep 7;17(1):205. doi: 10.1186/s12877-017-0604-3.

    PubMed 28882127

Questions about this trial

What is this clinical trial studying?

An observational study of Frail Elderly Syndrome, run by School of Health Sciences Geneva.

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: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Frailty Index (time frame: 1 year). 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 NCT03139162, which also lists 5 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 12 Apr 2023.

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