Skip to content

Ambulatory Geriatric Evaluation - Frailty Intervention Trial

Effectiveness of a Comprehensive CGA on Frailty in Community-dwelling Elderly People - A Randomised, Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01446757
Acronym
AGE-FIT
Enrollment
383
Registered
2011-10-05
Start date
2011-03-31
Completion date
2014-01-31
Last updated
2014-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deaths, Frail Elderly

Keywords

quality of life, feeling of security, costs, multiprofessional team, geriatric competence

Brief summary

The main purpose of this randomised controlled trial is to study if a Comprehensive Geriatric Assessment (CGA) and follow up for community-dwelling elderly people can improve outcomes such as health and health-related quality of life among both patients and relatives, feeling of safety among both patients and relatives and reduce costs, compared with usual care.

Detailed description

Frail older adults are at increased risk of vulnerability and serious health problems. This leads to increased suffering and higher healthcare utilization. There are major gaps in the knowledge needed to create the most favourable care model for preventing frailty and increasing health-related of life. The purpose of this randomised controlled trial is to study if a Comprehensive Geriatric Assessment and follow up in community-dwelling elderly people can prevent frailty, hospitalisation and adverse effects of frailty, improve health and health-related quality of life, and reduce costs, compared with usual care. In a randomized, controlled trial with 24 months of follow-up, a total of 430 older adults with multimorbidity will be randomized into two groups. The intervention group will receive Comprehensive Geriatric Assessment and follow up and the same standard health care services as the control group. The Comprehensive Geriatric Assessment and follow up will be provides through an outpatient facility that tailors care from a holistic perspective and, based on each patient's individual needs in line with the policy program that Sweden's pensioners' organizations have presented in 2010 together with the Swedish Association of Geriatric Medicine. The team includes, among other things. a. geriatricians, nurses, physiotherapists, assistance officer, dietician, pharmacist and co-operation with the dental hygienist. The primary outcome is development of frailty and hospitalization. Secondary outcomes are adverse effects of frailty, health and health-related quality of life and costs. There is a knowledge gap of how health care can identify persons with frailty and risks for frailty and how to meet their specific care needs. The study aims to fill a clinically important knowledge gap that can guide further development of future care for older people with multi-morbidity and frailty. CGA is readily transferable to clinical practice.

Interventions

Medical assessment (co-morbid condition, physical and neurological examination, medication review, nutrition, and blood-tests to identify anaemia, diabetes, metabolism and liver- and kidney function); assessment of functioning (ADL/IADL, fall risk), psychological assessment (cognitive decline and depression) and assessment of social and environmental conditions. The care plan is based on the CGA and will be individualised and carried out in discussion with the patient and his/her caregivers. The care will be carried out by an inter-professional Geriatric Team with employees from both the county council and the municipality. The team consists of a core team (including geriatrician and nurse) and a support team (including a social worker, occupational therapist, dietician, pharmacist, physiotherapist, and dental hygienist). The care will involve treatment for unstable medical conditions and support of patients and their caregivers. The team will have regular team conferences.

PROCEDUREcontrol group

No intervention

Sponsors

Swedish Association of Local Authorities and Regions
CollaboratorOTHER
Linkoeping University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Elderly 75 years and above * Have been hospitalized three or more times in the last 12 months * Have three or more diagnoses in their medical records according to the International Classification of Diseases (ICD-10) * Live in their own homes (not nursing home) in the municipality of Norrkoeping * Accept to participate in the study.

Exclusion criteria

\- Fulfilling the inclusion criteria but living in a special accommodation for the elderly

Design outcomes

Primary

MeasureTime frameDescription
Hospitalisation24 monthsNumber of hospitalisations and in-care stays during the trial
Frailty24 monthsUnintentional weight loss ≥5% of the previous year. Exhaustion is assessed by two questions from the Centre for Epidemiologic Studies-Depression Scale. Low physical activity includes assessment of habitual physical activity level by using the Swedish version of the International Physical Activity Questionnaire short version (IPAQ-S).Slow walking speed is determined from the better of two attempts at usual comfortable walking speed over 4 m with or without a walking aid. Weakness (muscle strength) is assessed by maximal grip strength.

Secondary

MeasureTime frameDescription
Depression0 and 24 monthsDepression is assessed using the Geriatric Depression Scale (GDS-15
Health related quality of life0 and 24 monthsHealth related quality of life (HRQL) is assessed by using the Nottingham Health Profile, first part (NHP) and the generic EuroQol questionnaire (EQ-5D)
Nutrition0 and 24 monthsThe Mini Nutritional Assessment form (MNA), is used to assess nutritional status. The MNA includes 18 items.
Activities of Daily Living0 and 24 monthsBarthels index
Cognition0 and 24 monthsCognition is assessed by the Mini-Mental State Examination
Costs24 months1\) Contact and extent of contact with the municipality measured by working hours 2) Number of: visits to day-care centres, in-hospital stays (type of clinic and extent of these), visits to primary care facilities, geriatric ambulatories or other specialist ambulatories 3) Admissions to nursing care facilities
Feeling of security of the patient0, 12 and 24 monthsQuestionnaire
Feeling of security of the relatives0, 12 and 24 monthsQuestionnaire
Quality of life of relatives0, 12 and 24 monthsQuestionnaire
Falls0 and 24 monthsthe patient is asked about falls in the last 6 months
Symptoms0 and 24 monthsSymptoms experienced during the previous week (frequency, intensity, and distress) are assessed by the The Memorial Symptom Assessment Scale (MSAS), which measures 32 different symptoms.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026