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Frailty and Complexity Among Home Service Recipients (fraXity)

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ClinicalTrials.gov Identifier: NCT03883425
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : March 22, 2019
Sponsor:
Collaborators:
Swiss National Science Foundation
Geneva institution for homecare and assistance (imad)
Information provided by (Responsible Party):
Catherine Ludwig, School of Health Sciences Geneva

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.

Condition or disease Intervention/treatment
Frail Elderly Syndrome Other: interRAI-HC assessments

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Frailty and Complexity Among Home Service Recipients: a Case-control Longitudinal Study
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : August 31, 2020

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




Primary Outcome Measures :
  1. Frailty Index [ Time Frame: at baseline ]
    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)

  2. Complexity Index [ Time Frame: at baseline ]
    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.

  3. Change in frailty Index [ Time Frame: at 6 months and at 12 months ]
    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.

  4. Change in complexity Index [ Time Frame: at 6 months and at 12 months ]
    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.


Secondary Outcome Measures :
  1. Number of participants with falls [ Time Frame: at 6 month, at 12 months ]
    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.

  2. Number of participants with hospitalizations [ Time Frame: at 6 month, at 12 months ]
    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.

  3. Number of participants with physician visits [ Time Frame: at 6 month, at 12 months ]
    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.

  4. Number of participants with emergency admissions [ Time Frame: at 6 month, at 12 months ]
    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.

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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes 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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883425


Contacts
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Contact: Catherine Ludwig, PhD +41 22 388 56 12 catherine.ludwig@hesge.ch
Contact: Catherine Busnel, RN +41 22 420 22 76 catherine.busnel@imad-ge.ch

Locations
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Switzerland
School of Health Sciences Geneva Recruiting
Geneva, Switzerland, 1206
Contact: Clara James, PhD    +41 22 388 56 77    clara.james@hesge.ch   
Sponsors and Collaborators
School of Health Sciences Geneva
Swiss National Science Foundation
Geneva institution for homecare and assistance (imad)
Investigators
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Principal Investigator: Catherine Ludwig, PhD School of Health Sciences Geneva

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Catherine Ludwig, UAS associate professor, School of Health Sciences Geneva
ClinicalTrials.gov Identifier: NCT03883425     History of Changes
Other Study ID Numbers: AGP 84770
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: 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.
URL: http://forscenter.ch

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Catherine Ludwig, School of Health Sciences Geneva:
Home Care Services
Geriatric Assessment
Aging
Frailty
Complexity
Nursing
Additional relevant MeSH terms:
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Frailty
Pathologic Processes