Ambulatory Geriatric Evaluation - Frailty Intervention Trial (AGE-FIT)

Linköping University (LiU)

Status: Completed

Conditions: Deaths; Frail Elderly

Treatments: Procedure: The intervention group; Procedure: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT01446757

2011/41-31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 383 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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383 participants in 2 patient groups, including a placebo group

The intervention group

Experimental group

Description:

The intervention group will receive Comprehensive Geriatric Assessment and follow up as a complement to 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.

Treatment:

Procedure: The intervention group

Control group

Placebo Comparator group

Description:

The control group will receive care in the same way as usual meaning access to primary care, hospital in- and outpatient care and care received by the municipality. The only difference between the two groups are that the control group will not have access to the geriatric care team.

Treatment:

Procedure: control group