Frailty and Complexity Among Home Service Recipients
fraXity
1 other identifier
observational
231
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 18, 2019
CompletedFirst Posted
Study publicly available on registry
March 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedDecember 2, 2020
December 1, 2020
2.2 years
March 18, 2019
December 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (5)
Number of participants with falls
at 6 month, at 12 months
Number of participants with hospitalizations
at 6 month, at 12 months
Number of participants with physician visits
at 6 month, at 12 months
Number of participants with emergency admissions
at 6 month, at 12 months
Mortality rate
at 6 month, at 12 months
Study Arms (3)
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
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
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.
Interventions
Standardized geriatric assessments done with the interRAI-HC instrument (Canadian French version 9.1) by trained nurses
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- living in hospital / nursing home
- not resident of Canton Geneva, Switzerland
- not fluent in French
- disoriented in time and space
- person under tutorship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Health Sciences Geneva
Geneva, 1206, Switzerland
Related Publications (4)
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.
PMID: 9256857BACKGROUNDLudwig 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.
PMID: 28882127BACKGROUNDBusnel 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.
PMID: 35751082DERIVEDLudwig 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.
PMID: 31382880DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Ludwig, PhD
School of Health Sciences Geneva
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- UAS associate professor
Study Record Dates
First Submitted
March 18, 2019
First Posted
March 20, 2019
Study Start
September 1, 2018
Primary Completion
November 30, 2020
Study Completion
November 30, 2020
Last Updated
December 2, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- 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.
- 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.
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.