Clinical trial NCT03883425: Frailty and Complexity Among Home Service Recipients
Official title: Frailty and Complexity Among Home Service Recipients: a Case-control Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frail Elderly Syndrome
Keywords: Home Care Services
Geriatric Assessment
Aging
Frailty
Complexity
Nursing
Lead sponsor: School of Health Sciences Geneva
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Geneva institution for homecare and assistance (imad)
First posted: 2019-03-20
Enrollment: 231
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Frailty Index
timeFrame: at baseline
measure: Complexity Index
timeFrame: at baseline
measure: Change in frailty Index
timeFrame: at 6 months and at 12 months
measure: Change in complexity Index
timeFrame: at 6 months and at 12 months
Secondary outcomes:
measure: Number of participants with falls
timeFrame: at 6 month, at 12 months
measure: Number of participants with hospitalizations
timeFrame: at 6 month, at 12 months
measure: Number of participants with physician visits
timeFrame: at 6 month, at 12 months
measure: Number of participants with emergency admissions
timeFrame: at 6 month, at 12 months
measure: Mortality rate
timeFrame: at 6 month, at 12 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: School of Health Sciences Geneva
Study officials:
affiliation: School of Health Sciences Geneva
name: Catherine Ludwig, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.