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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Completed

Conditions: Frail Elderly Syndrome

Treatments: Other: CGA, medication review, exercise and cognitive stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03591055

PI16/01683

Details and patient eligibility

About

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 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.

Enrollment: 300 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Intervention Group

Experimental group

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).

Treatment:

Other: CGA, medication review, exercise and cognitive stimulation

Control group

No Intervention group

Description:

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