NCT03883425: fraXity

Frailty and Complexity Among Home Service Recipients

Completed Last updated 2 December 2020

What this trial tests

trial testing interRAI-HC assessments in Frail Elderly Syndrome in 231 participants. Completed in 30 November 2020.

Timeline

1 September 2018

Primary endpoint
30 November 2020

30 November 2020

Quick facts

Lead sponsor	School of Health Sciences Geneva
Status	Completed
Study type	OBSERVATIONAL
Enrollment	231
Start date	1 September 2018
Primary completion	30 November 2020
Estimated completion	30 November 2020
Sites	1 location across Switzerland

Drugs / interventions tested

• interRAI-HC assessments

Conditions studied

• Frail Elderly Syndrome — all drugs for Frail Elderly Syndrome →

Sponsor

School of Health Sciences Geneva

Who can join

65 and older, any sex, with Frail Elderly Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Protocol of a case-control longitudinal study (fraXity) assessing frailty and complexity among Swiss home service recipients using interRAI-HC assessments.
   Ludwig C, Busnel C. · · 2019 · cited 6× · PMID 31382880 · DOI 10.1186/s12877-019-1230-z
2. Assessing multidimensional complexity in home care: congruencies and discrepancies between patients and nurses.
   Busnel C, Vallet F, Ashikali EM, Ludwig C. · · 2022 · cited 3× · PMID 35751082 · DOI 10.1186/s12912-022-00942-x