Frail Elderly Syndrome
Conditions
Keywords
Frail elderly, Clinical Trial
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.
Interventions
OTHERCGA, 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.
Sponsors
Institut Català de la Salut
Instituto de Salud Carlos III
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Short Physical Performance Battery (SPPB) at 3 and 18 months | 0, 3, 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 Health Related Quality of Life (EuroQol 5D) at 3 and 18 months | 0, 3, 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. |
| Change from Baseline in the Quick Mild Cognitive Impairment Screen (Qmci-S) at 3 and 18 months | 0, 3, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Functional Capacity at 3 and 18 months | 0, 3, 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 | 0, 3, 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 | 0,3 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 | 0,3,18 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health care costs | 18 months | Direct health care costs |
| Number of Participants who die during follow-up, at 18 months | 18 months | Death |
| Number of Participants Hospitalized during follow-up, at 18 months | 18 months | Hospitalization including prolonged admission or readmission |
| Number of participants that comply with the programme schedules at 3 and 18 months | 3 months and 18 months | Compliance with the programme: number of undergone interventions out of total prescribed interventions (including activities, referrals or prescriptions) |
| Number of participants (patients, caregivers and professionals) that are satisfied with the programme at 3 and 18 months | 3 months and 18 months | Satisfaction with the programme, measured with an ad hoc questionnaire. |
| Number of Participants Institutionalized during follow-up, at 18 months | 18 months | Admission to long-term care {nursing home} |
Countries
Spain
Outcome results
None listed