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Completed

NCT Number: NCT01446757

Ambulatory Geriatric Evaluation - Frailty Intervention Trial

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.

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Key information

Conditions

Frail Elderly Death Deaths Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Geriatric Medicine

Norrköping, 60182, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The intervention group

Procedure

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 names: Geriatric care team

Control Group

Procedure

No intervention

Primary outcomes

  1. Hospitalisation

    Time frame: 24 months

    Number of hospitalisations and in-care stays during the trial

  2. Frailty

    Time frame: 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.

Secondary outcomes

  1. Cognition

    Time frame: 0 and 24 months

    Cognition is assessed by the Mini-Mental State Examination

  2. Symptoms

    Time frame: 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.

  3. Depression

    Time frame: 0 and 24 months

    Depression is assessed using the Geriatric Depression Scale (GDS-15

  4. Health related quality of life

    Time frame: 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)

  5. Nutrition

    Time frame: 0 and 24 months

    The Mini Nutritional Assessment form (MNA), is used to assess nutritional status. The MNA includes 18 items.

  6. Activities of Daily Living

    Time frame: 0 and 24 months

    Barthels index

  7. Falls

    Time frame: 0 and 24 months

    the patient is asked about falls in the last 6 months

  8. Costs

    Time frame: 24 months

    • 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

  9. Feeling of security of the patient

    Time frame: 0, 12 and 24 months

    Questionnaire

  10. Feeling of security of the relatives

    Time frame: 0, 12 and 24 months

    Questionnaire

  11. Quality of life of relatives

    Time frame: 0, 12 and 24 months

    Questionnaire

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Swedish Association of Local Authorities and Regions

Registry information

Official study title

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

Acronym: AGE-FIT

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Oct 5, 2011
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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