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

This study has been completed.
Sponsor:
Collaborator:
Swedish Association of Local Authorities and Regions
Information provided by (Responsible Party):
Anne Ekdahl, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01446757
First received: September 19, 2011
Last updated: March 29, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Frail Elderly
Deaths
Procedure: The intervention group
Procedure: control group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effectiveness of a Comprehensive CGA on Frailty in Community-dwelling Elderly People - A Randomised, Controlled Trial

Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • Hospitalisation [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Number of hospitalisations and in-care stays during the trial

  • Frailty [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Cognition [ Time Frame: 0 and 24 months ] [ Designated as safety issue: No ]
    Cognition is assessed by the Mini-Mental State Examination

  • Symptoms [ Time Frame: 0 and 24 months ] [ Designated as safety issue: Yes ]
    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.

  • Depression [ Time Frame: 0 and 24 months ] [ Designated as safety issue: No ]
    Depression is assessed using the Geriatric Depression Scale (GDS-15

  • Health related quality of life [ Time Frame: 0 and 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0 and 24 months ] [ Designated as safety issue: No ]
    The Mini Nutritional Assessment form (MNA), is used to assess nutritional status. The MNA includes 18 items.

  • Activities of Daily Living [ Time Frame: 0 and 24 months ] [ Designated as safety issue: No ]
    Barthels index

  • Falls [ Time Frame: 0 and 24 months ] [ Designated as safety issue: Yes ]
    the patient is asked about falls in the last 6 months

  • Costs [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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

  • Feeling of security of the patient [ Time Frame: 0, 12 and 24 months ] [ Designated as safety issue: No ]
    Questionnaire

  • Feeling of security of the relatives [ Time Frame: 0, 12 and 24 months ] [ Designated as safety issue: No ]
    Questionnaire

  • Quality of life of relatives [ Time Frame: 0, 12 and 24 months ] [ Designated as safety issue: No ]
    Questionnaire


Enrollment: 383
Study Start Date: March 2011
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: Geriatric care team
Placebo Comparator: 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.
Procedure: control group
No intervention
Other Name: control group

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

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446757

Locations
Sweden
Department of Geriatric Medicine
Norrkoeping, Sweden, 60182
Sponsors and Collaborators
Linkoeping University
Swedish Association of Local Authorities and Regions
Investigators
Principal Investigator: Anne W Ekdahl, Physisian Linkopeing University
  More Information

No publications provided

Responsible Party: Anne Ekdahl, Senior Consultant, geriatrician, Linkoeping University
ClinicalTrials.gov Identifier: NCT01446757     History of Changes
Other Study ID Numbers: 2011/41-31
Study First Received: September 19, 2011
Last Updated: March 29, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Linkoeping University:
quality of life
feeling of security
costs
multiprofessional team
geriatric competence

ClinicalTrials.gov processed this record on November 20, 2014