Clinical trial NCT01446757: Ambulatory Geriatric Evaluation - Frailty Intervention Trial
Official title: Effectiveness of a Comprehensive CGA on Frailty in Community-dwelling Elderly People - A Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Deaths
Keywords: quality of life
feeling of security
costs
multiprofessional team
geriatric competence
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Swedish Association of Local Authorities and Regions
First posted: 2011-10-05
Enrollment: 383
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospitalisation
timeFrame: 24 months
measure: Frailty
timeFrame: 24 months
Secondary outcomes:
measure: Cognition
timeFrame: 0 and 24 months
measure: Symptoms
timeFrame: 0 and 24 months
measure: Depression
timeFrame: 0 and 24 months
measure: Health related quality of life
timeFrame: 0 and 24 months
measure: Nutrition
timeFrame: 0 and 24 months
measure: Activities of Daily Living
timeFrame: 0 and 24 months
measure: Falls
timeFrame: 0 and 24 months
measure: Costs
timeFrame: 24 months
measure: Feeling of security of the patient
timeFrame: 0, 12 and 24 months
measure: Feeling of security of the relatives
timeFrame: 0, 12 and 24 months
measure: Quality of life of relatives
timeFrame: 0, 12 and 24 months
Other outcomes:
Locations:
city: Norrkoeping
country: Sweden
facility: Department of Geriatric Medicine
Study officials:
affiliation: Linkopeing University
name: Anne W Ekdahl, Physisian
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klompstra L, Ekdahl AW, Krevers B, Milberg A, Eckerblad J. Factors related to health-related quality of life in older people with multimorbidity and high health care consumption over a two-year period. BMC Geriatr. 2019 Jul 5;19(1):187. doi: 10.1186/s12877-019-1194-z.
citation: Lundqvist M, Alwin J, Henriksson M, Husberg M, Carlsson P, Ekdahl AW. Cost-effectiveness of comprehensive geriatric assessment at an ambulatory geriatric unit based on the AGe-FIT trial. BMC Geriatr. 2018 Jan 31;18(1):32. doi: 10.1186/s12877-017-0703-1.
citation: Ekdahl AW, Wirehn AB, Alwin J, Jaarsma T, Unosson M, Husberg M, Eckerblad J, Milberg A, Krevers B, Carlsson P. Costs and Effects of an Ambulatory Geriatric Unit (the AGe-FIT Study): A Randomized Controlled Trial. J Am Med Dir Assoc. 2015 Jun 1;16(6):497-503. doi: 10.1016/j.jamda.2015.01.074. Epub 2015 Feb 18.