Ambulatory Geriatric Evaluation - Frailty Intervention Trial

Frail Elderly Clinical Trial

— AGE-FIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446757
• Other study ID #: 2011/41-31
• Status: Completed
• Phase: N/A
• First received: September 19, 2011
• Last updated: March 29, 2014
• Start date: March 2011
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Deaths
• Frail Elderly

Intervention

Procedure:
• The intervention group
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.
• control group
No intervention

Locations

Country	Name	City	State
Sweden	Department of Geriatric Medicine	Norrkoeping

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	Swedish Association of Local Authorities and Regions

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalisation	Number of hospitalisations and in-care stays during the trial	24 months	Yes
Primary	Frailty	Unintentional 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.	24 months	Yes
Secondary	Cognition	Cognition is assessed by the Mini-Mental State Examination	0 and 24 months	No
Secondary	Symptoms	Symptoms experienced during the previous week (frequency, intensity, and distress) are assessed by the "The Memorial Symptom Assessment Scale" (MSAS), which measures 32 different symptoms.	0 and 24 months	Yes
Secondary	Depression	Depression is assessed using the Geriatric Depression Scale (GDS-15	0 and 24 months	No
Secondary	Health related quality of life	Health related quality of life (HRQL) is assessed by using the Nottingham Health Profile, first part (NHP) and the generic "EuroQol" questionnaire (EQ-5D)	0 and 24 months	No
Secondary	Nutrition	The Mini Nutritional Assessment form (MNA), is used to assess nutritional status. The MNA includes 18 items.	0 and 24 months	No
Secondary	Activities of Daily Living	Barthels index	0 and 24 months	No
Secondary	Falls	the patient is asked about falls in the last 6 months	0 and 24 months	Yes
Secondary	Costs	1) 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	24 months	No
Secondary	Feeling of security of the patient	Questionnaire	0, 12 and 24 months	No
Secondary	Feeling of security of the relatives	Questionnaire	0, 12 and 24 months	No
Secondary	Quality of life of relatives	Questionnaire	0, 12 and 24 months	No