Frailty and Complexity Among Home Service Recipients

Frail Elderly Syndrome Clinical Trial

— fraXity  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883425
• Other study ID #: AGP 84770
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: December 2020
• Source: School of Health Sciences Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frail Elderly Syndrome
• Frailty

Intervention

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

Locations

Country	Name	City	State
Switzerland	School of Health Sciences Geneva	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
School of Health Sciences Geneva	Geneva institution for homecare and assistance (imad), Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View Citation

Morris JN, Fries BE, Steel K, Ikegami N, Bernabei R, Carpenter GI, Gilgen R, Hirdes JP, Topinková E. Comprehensive clinical assessment in community setting: applicability of the MDS-HC. J Am Geriatr Soc. 1997 Aug;45(8):1017-24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mortality rate	Number of deaths (yes/no); collected from relatives or through public databases (www.hommages.ch).	at 6 month, at 12 months