Frailty Assessment and Treatment Strategies in the Elderly at Risk of Functional Decline in the Community

Overview

This study aims to design a patient -centered program to prevent or delay frailty , functional decline and adverse events, and evaluates the effectiveness of the program with a randomized clinical trial.

Full Title of Study: “Frailty Assessment and Multimodal Treatment Strategies in the Elderly at Risk of Adverse Results and Functional Decline in the Community”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 31, 2019

Detailed Description

Objective: To design and evaluate the implementation and impact of a multimodal intervention focused on elderly patients living in the community in preventing or delaying frailty, functional decline and risk of institutionalization, hospitalization and death.

Design: Study in two phases: a qualitative study to develop the intervention and a randomized clinical trial with parallel arms and control group.

Intervention: Participants in the control group will receive the usual standard care and regular referrals. Patients in the intervention group will be first derived to a nurse case manager for initial application of a comprehensive geriatric assessment (CGA). Then patient-centered interventions will be prescribed, according to the different target areas identified in the geriatric assessment, along with medication review, aerobics exercise plan and memory workshops following the model adapted in Phase I.

After 3 and 18 months, measures of functional and cognitive performance, quality of life, frailty, adverse outcomes (institutionalization, hospitalization, death) and health care costs will be collected.

Interventions

  • Other: CGA, medication review, exercise and cognitive stimulation
    • Comprehensive geriatric assessment. Patient-centered interventions according to the different target areas identified in the geriatric assessment. Medication review. Groupal Exercise plan and memory workshops.

Arms, Groups and Cohorts

  • Experimental: Intervention Group
    • Patients in the intervention group will be first derived to a nurse case manager for initial application of a comprehensive geriatric assessment. Then patient-centered interventions will be prescribed, according to the different target areas identified in the geriatric assessment. All participants in the intervention group will undergo a medication review and will also perform an aerobics exercise plan in the primary care centre, 60-minute session twice a week on non-consecutive days for 6 weeks (12 sessions of 60 minutes each) and memory workshops (10 sessions).
  • No Intervention: Control group
    • Participants in the control group will receive the usual standard care and regular referrals.

Clinical Trial Outcome Measures

Primary Measures

  • Change from Baseline in Short Physical Performance Battery (SPPB) at 3 and 18 months
    • Time Frame: 0, 3, 18 months
    • The Short Physical Performance Battery (SPPB) is a standardised assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).
  • Change from Baseline in the Quick Mild Cognitive Impairment Screen (Qmci-S) at 3 and 18 months
    • Time Frame: 0, 3, 18 months
    • The Quick Mild Cognitive Impairment (Qmci) screen is a multi-purpose, short cognitive screening instrument designed to differentiate between normal cognitive function, subjective cognitive disorders, mild cognitive impairment (MCI) and early dementia and to measure change over time.
  • Change from Baseline in Health Related Quality of Life (EuroQol 5D) at 3 and 18 months
    • Time Frame: 0, 3, 18 months
    • EuroQol 5D EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.

Secondary Measures

  • Change from Baseline in Functional Capacity at 3 and 18 months
    • Time Frame: 0, 3, 18 months
    • Activities of daily living: Barthel Index and Lawton&Brody Index
  • Change from Baseline in the Risk Instrument for Screening in the Community (RISC) at 3 and 18 months
    • Time Frame: 0, 3, 18 months
    • Risk Instrument for Screening in the Community is a validated short (2-5 min), global subjective assessment of risk created to identify patients’ 1-year risk of three outcomes: institutionalization, hospitalization and death.
  • Change from Baseline in Clinical Frailty Scale (CFS) at 3 and 18 months
    • Time Frame: 0,3 18 months
    • The clinical frailty scale is a 9 points measure of frailty based on clinical judgement.
  • Change from Baseline in the Gerontopole Frailty Screening Tool (GFST) at 3 and 18 months
    • Time Frame: 0,3,18 months
    • Gerontopole Frailty Screening Tool is a questionnaire aimed to measure general signs and/or symptoms potentially indicating the presence of an underlying frailty. These questions largely mirror the criteria that are commonly used to operationalize the frailty status.

Participating in This Clinical Trial

Inclusion Criteria

  • Positive screen in the accumulation of deficits electronic frailty index
  • Positive screen with Gerontopole screening tool and/or RISC tool

Exclusion Criteria

  • Living in an institution
  • Advanced conditions with short life expectancy
  • Severe disability
  • Severe Dementia

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jordi Gol i Gurina Foundation
  • Collaborator
    • Institut CatalĂ  de la Salut
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • FRANCISCO Orfila Pernas, Principal Investigator, Institut Catala de Salut
  • Overall Contact(s)
    • FRANCISCO Orfila Pernas, 0034932073760, forfila.bcn.ics@gencat.cat

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