Frailty and Complexity Among Home Service Recipients (fraXity)

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.

Study Overview

• Status: Completed
• Conditions: Frail Elderly Syndrome
• Intervention / Treatment: Other: interRAI-HC assessments

• Study Type: Observational
• Enrollment (Actual): 231

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1206
    • School of Health Sciences Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case 1: formal home service recipients; Adults aged 65 or older living at home who receive formal home service (household, meal delivery, transportation, shopping) at least one a week	Other: interRAI-HC assessments; Standardized geriatric assessments done with the interRAI-HC instrument (Canadian French version 9.1) by trained nurses
Case 2: formal home care recipients; Adults aged 65 or older living at home who receive formal home care (shower/bath nursing assistance, nursing care) at least once a week	Other: interRAI-HC assessments; Standardized geriatric assessments done with the interRAI-HC instrument (Canadian French version 9.1) by trained nurses
Control: free of formal home care or home service; Adults aged 65 or older living at home who do not receive formal home care or home service.	Other: interRAI-HC assessments; Standardized geriatric assessments done with the interRAI-HC instrument (Canadian French version 9.1) by trained nurses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	at baseline
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.	at baseline
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.	at 6 months and at 12 months
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.	at 6 months and at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 6 month, at 12 months
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.	at 6 month, at 12 months
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.	at 6 month, at 12 months
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.	at 6 month, at 12 months
Mortality rate	Number of deaths (yes/no); collected from relatives or through public databases (www.hommages.ch).	at 6 month, at 12 months

Collaborators and Investigators

• Sponsor: School of Health Sciences Geneva
• Collaborators: Swiss National Science Foundation; Geneva institution for homecare and assistance (imad)
• Investigators: Principal Investigator: Catherine Ludwig, PhD, School of Health Sciences Geneva

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 20, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Aging; Nursing; Frailty; Geriatric Assessment; Home Care Services; Complexity
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: AGP 84770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: At the end of the study, the recoded data set (SPSS format, cleaned and coded), the data codebook, references for the measurement instruments and all other relevant information related to the project (e.g. protocol) will be deposited at DARIS/FORS for data sharing and reuse.
• IPD Sharing Access Criteria: Data access and reuse, as well as intellectual property rights issues will be addressed through FORS standard contractual arrangements for a) the conditions of data deposit and b) the conditions of data use by a third party.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No