search
Back to results

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

Primary Purpose

Frail Elderly Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CGA, medication review, exercise and cognitive stimulation
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frail Elderly Syndrome focused on measuring Frail elderly, Clinical Trial

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IDIAP JGol

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control group

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

Change from Baseline in Functional Capacity at 3 and 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
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
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
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.

Full Information

First Posted
June 22, 2018
Last Updated
August 29, 2022
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Institut Català de la Salut, Instituto de Salud Carlos III
search

1. Study Identification

Unique Protocol Identification Number
NCT03591055
Brief Title
Frailty Assessment and Treatment Strategies in the Elderly at Risk of Functional Decline in the Community
Official Title
Frailty Assessment and Multimodal Treatment Strategies in the Elderly at Risk of Adverse Results and Functional Decline in the Community
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Institut Català de la Salut, Instituto de Salud Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome
Keywords
Frail elderly, Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group will receive the usual standard care and regular referrals.
Intervention Type
Other
Intervention Name(s)
CGA, medication review, exercise and cognitive stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Short Physical Performance Battery (SPPB) at 3 and 18 months
Description
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).
Time Frame
0, 3, 18 months
Title
Change from Baseline in the Quick Mild Cognitive Impairment Screen (Qmci-S) at 3 and 18 months
Description
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.
Time Frame
0, 3, 18 months
Title
Change from Baseline in Health Related Quality of Life (EuroQol 5D) at 3 and 18 months
Description
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.
Time Frame
0, 3, 18 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Functional Capacity at 3 and 18 months
Description
Activities of daily living: Barthel Index and Lawton&Brody Index
Time Frame
0, 3, 18 months
Title
Change from Baseline in the Risk Instrument for Screening in the Community (RISC) at 3 and 18 months
Description
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.
Time Frame
0, 3, 18 months
Title
Change from Baseline in Clinical Frailty Scale (CFS) at 3 and 18 months
Description
The clinical frailty scale is a 9 points measure of frailty based on clinical judgement.
Time Frame
0,3 18 months
Title
Change from Baseline in the Gerontopole Frailty Screening Tool (GFST) at 3 and 18 months
Description
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.
Time Frame
0,3,18 months
Other Pre-specified Outcome Measures:
Title
Number of Participants Institutionalized during follow-up, at 18 months
Description
Admission to long-term care {nursing home}
Time Frame
18 months
Title
Number of Participants Hospitalized during follow-up, at 18 months
Description
Hospitalization including prolonged admission or readmission
Time Frame
18 months
Title
Number of Participants who die during follow-up, at 18 months
Description
Death
Time Frame
18 months
Title
Health care costs
Description
Direct health care costs
Time Frame
18 months
Title
Number of participants that comply with the programme schedules at 3 and 18 months
Description
Compliance with the programme: number of undergone interventions out of total prescribed interventions (including activities, referrals or prescriptions)
Time Frame
3 months and 18 months
Title
Number of participants (patients, caregivers and professionals) that are satisfied with the programme at 3 and 18 months
Description
Satisfaction with the programme, measured with an ad hoc questionnaire.
Time Frame
3 months and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FRANCISCO Orfila Pernas
Organizational Affiliation
Institut Catala de Salut
Official's Role
Principal Investigator
Facility Information:
Facility Name
IDIAP JGol
City
Barcelona
ZIP/Postal Code
08007
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs