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Completed

NCT Number: NCT03883425

Frailty and Complexity Among Home Service Recipients

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.

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Key information

Conditions

Frail Elderly Syndrome Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

School of Health Sciences Geneva

Geneva, 1206, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

interRAI-HC assessments

Other

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

School of Health Sciences Geneva

Other

Collaborators

  • Geneva institution for homecare and assistance (imad)
  • Swiss National Science Foundation

Registry information

Official study title

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

Acronym: fraXity

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 20, 2019
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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