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

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

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.

Study Overview

• Status: Completed
• Conditions: Frail Elderly Syndrome
• Intervention / Treatment: Other: CGA, medication review, exercise and cognitive stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08007
    • IDIAP JGol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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.
No Intervention: Control group; Participants in the control group will receive the usual standard care and regular referrals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Short Physical Performance Battery (SPPB) at 3 and 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).	0, 3, 18 months
Change from Baseline in the Quick Mild Cognitive Impairment Screen (Qmci-S) at 3 and 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.	0, 3, 18 months
Change from Baseline in Health Related Quality of Life (EuroQol 5D) at 3 and 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.	0, 3, 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Functional Capacity at 3 and 18 months	Activities of daily living: Barthel Index and Lawton&Brody Index	0, 3, 18 months
Change from Baseline in the Risk Instrument for Screening in the Community (RISC) at 3 and 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.	0, 3, 18 months
Change from Baseline in Clinical Frailty Scale (CFS) at 3 and 18 months	The clinical frailty scale is a 9 points measure of frailty based on clinical judgement.	0,3 18 months
Change from Baseline in the Gerontopole Frailty Screening Tool (GFST) at 3 and 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.	0,3,18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Institutionalized during follow-up, at 18 months	Admission to long-term care {nursing home}	18 months
Number of Participants Hospitalized during follow-up, at 18 months	Hospitalization including prolonged admission or readmission	18 months
Number of Participants who die during follow-up, at 18 months	Death	18 months
Health care costs	Direct health care costs	18 months
Number of participants that comply with the programme schedules at 3 and 18 months	Compliance with the programme: number of undergone interventions out of total prescribed interventions (including activities, referrals or prescriptions)	3 months and 18 months
Number of participants (patients, caregivers and professionals) that are satisfied with the programme at 3 and 18 months	Satisfaction with the programme, measured with an ad hoc questionnaire.	3 months and 18 months

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Collaborators: Institut Català de la Salut; Instituto de Salud Carlos III
• Investigators: Principal Investigator: FRANCISCO Orfila Pernas, Institut Catala de Salut

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Clinical Trial; Frail elderly
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: PI16/01683

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No