Ambulatory Geriatric Evaluation - Frailty Intervention Trial

Not Applicable

Completed

• Conditions: Deaths; Frail Elderly
• Interventions: Procedure: The intervention group; Procedure: control group

• Registration Number: NCT01446757
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-10-04
• Study First Posted: 2011-10-05
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-29
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 383

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The intervention group	The intervention group	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.
Control group	control group	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.

Primary Outcome Measures

Name	Time	Method
Frailty	24 months	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.
Hospitalisation	24 months	Number of hospitalisations and in-care stays during the trial

Secondary Outcome Measures

Name	Time	Method
Feeling of security of the patient	0, 12 and 24 months	Questionnaire
Feeling of security of the relatives	0, 12 and 24 months	Questionnaire
Symptoms	0 and 24 months	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.
Quality of life of relatives	0, 12 and 24 months	Questionnaire
Cognition	0 and 24 months	Cognition is assessed by the Mini-Mental State Examination
Health related quality of life	0 and 24 months	Health related quality of life (HRQL) is assessed by using the Nottingham Health Profile, first part (NHP) and the generic "EuroQol" questionnaire (EQ-5D)
Nutrition	0 and 24 months	The Mini Nutritional Assessment form (MNA), is used to assess nutritional status. The MNA includes 18 items.
Activities of Daily Living	0 and 24 months	Barthels index
Falls	0 and 24 months	the patient is asked about falls in the last 6 months
Depression	0 and 24 months	Depression is assessed using the Geriatric Depression Scale (GDS-15
Costs	24 months	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

Trial Locations

Locations (1)

Department of Geriatric Medicine; 🇸🇪 Norrkoeping, Sweden