NCT03591055

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

1.5 years

First QC Date

June 22, 2018

Last Update Submit

August 29, 2022

Conditions

Frail Elderly Syndrome

Keywords

Frail elderlyClinical Trial

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Change from Baseline in Functional Capacity at 3 and 18 months

    0, 3, 18 months

  • Change from Baseline in the Risk Instrument for Screening in the Community (RISC) at 3 and 18 months

    0, 3, 18 months

  • Change from Baseline in Clinical Frailty Scale (CFS) at 3 and 18 months

    0,3 18 months

  • Change from Baseline in the Gerontopole Frailty Screening Tool (GFST) at 3 and 18 months

    0,3,18 months

Other Outcomes (6)

  • Number of Participants Institutionalized during follow-up, at 18 months

    18 months

  • Number of Participants Hospitalized during follow-up, at 18 months

    18 months

  • Number of Participants who die during follow-up, at 18 months

    18 months

  • +3 more other outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Participants in the control group will receive the usual standard care and regular referrals.

Interventions

CGA, medication review, exercise and cognitive stimulationOTHER

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.

Intervention Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IDIAP JGol

Barcelona, 08007, Spain

Location

MeSH Terms

Interventions

Medication ReviewExercise

Intervention Hierarchy (Ancestors)

Medication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care ManagementMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • FRANCISCO Orfila Pernas

    Institut Catala de Salut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2018

First Posted

July 18, 2018

Study Start

August 1, 2018

Primary Completion

January 30, 2020

Study Completion

December 31, 2021

Last Updated

September 1, 2022

Record last verified: 2022-08

Locations

ES(1)