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Frail Elderly SyndromefraXityNCT03883425

Frailty and Complexity Among Home Service Recipients

An observational study of Frail Elderly Syndrome, run by School of Health Sciences Geneva at 1 site in Switzerland.

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 purpose of the study is to develop frailty and complexity computation algorithms based on the French version of the interRAI-HC and, in doing so, to provide homecare nurses with valid and reliable screening tools for their routine practice. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Frail Elderly Syndrome
What is being tested?
interRAI-HC assessments
How many people
231 participants
Where
1 siteSwitzerland
Study dates
1 Sep 2018to 30 Nov 2020
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 65 years and older
  • All sexes
  • Older adult

Study population: Community-dwelling older adults (aged 65 or older), fluent in French, living at home in Canton Geneva, Switzerland and volunteering to participate to the study.

Who may be able to join

  • living in the community (private home)
  • resident of Canton Geneva, Switzerland
  • ability to hold a conversation in French (expression, comprehension)
  • oriented in time and space

Who cannot join

  • living in hospital / nursing home
  • not resident of Canton Geneva, Switzerland
  • not fluent in French
  • disoriented in time and space
  • person under tutorship

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • School of Health Sciences Geneva

    Geneva, 1206

Other trials in Switzerland

About this study

Official title: Frailty and Complexity Among Home Service Recipients: a Case-control Longitudinal Study

The purpose of the study is to develop frailty and complexity computation algorithms based on the French version of the interRAI-HC and, in doing so, to provide homecare nurses with valid and reliable screening tools for their routine practice. By relying on a prospective observational case-control longitudinal study, the study intends to assess the predictive validity of the proposed indices with respect to undesirable health outcomes. Repeated measurement occasions, separated by 6-month intervals, will also allow for estimation of intra-individual change in frailty and complexity. In the study, elders living in the community and aged 65 or older are the target population, and three samples will be considered based on the a priori risks of adverse outcomes (case 1: formal home service recipients; case 2: formal home care recipients; control: free of formal home care or service). These groups will be compared on the observed rates of frailty and complexity and on their evolution over time. Results will allow for identification of subgroups of the aged population for whom early screening of frailty and complexity appears most relevant. Based on the findings, practice guideline will be proposed. They will entail the interpretation of the scores and recommendations for mounting adapted preventive strategies. Finally, the study will contribute to enhancing knowledge on the relation between frailty, a well-known concept in gerontology, and complexity, a concept increasingly referred to in the care literature but that still deserves operational and consensual definitions.

Being tested
interRAI-HC assessments
Keywords
Home Care Services, Geriatric Assessment, 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.

  • interRAI-HC assessmentsOther

    Standardized geriatric assessments done with the interRAI-HC instrument (Canadian French version 9.1) by trained nurses

Study groups in NCT03883425
Study groupRoleWhat they receive
Case 1: formal home service recipientsAdults aged 65 or older living at home who receive formal home service (household, meal delivery, transportation, shopping) at least one a week
Receives: Other: interRAI-HC assessments
Case 2: formal home care recipientsAdults aged 65 or older living at home who receive formal home care (shower/bath nursing assistance, nursing care) at least once a week
Receives: Other: interRAI-HC assessments
Control: free of formal home care or home serviceAdults aged 65 or older living at home who do not receive formal home care or home service.
Receives: Other: interRAI-HC assessments

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 interRAI-HC MDS divided by the number of deficits considered. Replication of Ludwig and Busnel, BMC, 2017 (REF2)

    Measured: at baseline

  2. Complexity Index

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

    Measured: at baseline

  3. Change in frailty Index

    Change in the frailty index value; Expressed as a proportion, with the frailty index value at baseline as denominator and the observed frailty value as numerator.

    Measured: at 6 months and at 12 months

  4. Change in complexity Index

    Change in the complexity index value; Expressed as a proportion, with the complexity index value at baseline as denominator and the observed complexity value as numerator.

    Measured: at 6 months and at 12 months

Secondary outcomes (5)

  1. Number of participants with falls

    Number of participants with falls in the 6 months prior each follow-up assessment (yes/no; if yes, number of falls that occurred); recorded prospectively by means of a life history calendar.

    Measured: at 6 month, at 12 months

  2. Number of participants with hospitalizations

    Number of participants with hospitalizations in the 6 months prior each follow-up assessment (yes/no; if yes, number of hospitalizations that occurred and lengths in days); recorded prospectively by means of a life history calendar.

    Measured: at 6 month, at 12 months

  3. Number of participants with physician visits

    Number of participants with physician visits in the 6 months prior each follow-up assessment (yes/no; if yes, number of visits that occurred); recorded prospectively by means of a life history calendar.

    Measured: at 6 month, at 12 months

  4. Number of participants with emergency admissions

    Number of participants with emergency admissions in the 6 months prior each follow-up assessment (yes/no; if yes, number of admissions that occurred); recorded prospectively by means of a life history calendar.

    Measured: at 6 month, at 12 months

  5. Mortality rate

    Number of deaths (yes/no); collected from relatives or through public databases (www.hommages.ch).

    Measured: at 6 month, at 12 months

Timeline

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

  1. First posted20 Mar 2019
  2. Study start1 Sep 2018
  3. Primary completion30 Nov 2020
  4. Study completion30 Nov 2020

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
Case-control
Time perspective
Prospective
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03883425
Sponsor's protocol ID
AGP 84770
Acronym
fraXity
Status last verified
Dec 2020
First submitted
18 Mar 2019
Last updated
2 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data and analytical codes will be shared in the form of computerized data files in SPSS format (\*.sav, \*.sps). Variable specification are written in SPSS syntaxes (\*.sps files). Syntaxes define for each variable (raw or recoded) its short name, its type (date, string, numerical), its label, its response values and labels, the values associated with missing data and the measurement scale. Whenever relevant, the syntax is annotated, providing, for example, the reference of the published guideline for recoding. All variable specifications are summarized in a codebook (generated by SPSS), which is completed by specifications on the data collection procedure and on the sources used as references for recoding. The dataset is free of individual personal information (named, dated of birth, addresses, etc.); unique numerical codes are used to identify participants.

Publications

  • 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

  • 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

  • Busnel C, Vallet F, Ashikali EM, Ludwig C. Assessing multidimensional complexity in home care: congruencies and discrepancies between patients and nurses. BMC Nurs. 2022 Jun 24;21(1):166. doi: 10.1186/s12912-022-00942-x.

    PubMed 35751082

  • Ludwig C, Busnel C. Protocol of a case-control longitudinal study (fraXity) assessing frailty and complexity among Swiss home service recipients using interRAI-HC assessments. BMC Geriatr. 2019 Aug 5;19(1):207. doi: 10.1186/s12877-019-1230-z.

    PubMed 31382880

Questions about this trial

What is this clinical trial studying?

An observational study of Frail Elderly Syndrome, run by School of Health Sciences Geneva at 1 site in Switzerland.

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 4 inclusion and 5 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 2 Dec 2020. 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 Switzerland. 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?

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: at baseline). The study lists 4 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 NCT03883425, which also lists 4 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 2 Dec 2020.

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