Clinical trial NCT03591055: 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
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Keywords: Frail elderly
Clinical Trial
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Institut Català de la Salut
name: Instituto de Salud Carlos III
First posted: 2018-07-18
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline in Short Physical Performance Battery (SPPB) at 3 and 18 months
timeFrame: 0, 3, 18 months
measure: Change from Baseline in the Quick Mild Cognitive Impairment Screen (Qmci-S) at 3 and 18 months
timeFrame: 0, 3, 18 months
measure: Change from Baseline in Health Related Quality of Life (EuroQol 5D) at 3 and 18 months
timeFrame: 0, 3, 18 months
Secondary outcomes:
measure: Change from Baseline in Functional Capacity at 3 and 18 months
timeFrame: 0, 3, 18 months
measure: Change from Baseline in the Risk Instrument for Screening in the Community (RISC) at 3 and 18 months
timeFrame: 0, 3, 18 months
measure: Change from Baseline in Clinical Frailty Scale (CFS) at 3 and 18 months
timeFrame: 0,3 18 months
measure: Change from Baseline in the Gerontopole Frailty Screening Tool (GFST) at 3 and 18 months
timeFrame: 0,3,18 months
Other outcomes:
measure: Number of Participants Institutionalized during follow-up, at 18 months
timeFrame: 18 months
measure: Number of Participants Hospitalized during follow-up, at 18 months
timeFrame: 18 months
measure: Number of Participants who die during follow-up, at 18 months
timeFrame: 18 months
measure: Health care costs
timeFrame: 18 months
measure: Number of participants that comply with the programme schedules at 3 and 18 months
timeFrame: 3 months and 18 months
measure: Number of participants (patients, caregivers and professionals) that are satisfied with the programme at 3 and 18 months
timeFrame: 3 months and 18 months
Locations:
city: Barcelona
country: Spain
facility: IDIAP JGol
Study officials:
affiliation: Institut Catala de Salut
name: FRANCISCO Orfila Pernas
role: PRINCIPAL_INVESTIGATOR
References: