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Frail ElderlyAGE-FITNCT01446757

Ambulatory Geriatric Evaluation - Frailty Intervention Trial

A study testing The intervention group in people with Frail Elderly and Deaths, run by Linkoeping University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Frail Elderly, Deaths
What is being tested?
The intervention group
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
383 participants
Where
1 siteSweden
Study dates
Mar 2011to Jan 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • Fulfilling the inclusion criteria but living in a special accommodation for the elderly

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Department of Geriatric Medicine

    Norrköping, 60182

Other trials in Sweden

About this study

Official title: Effectiveness of a Comprehensive CGA on Frailty in Community-dwelling Elderly People - A Randomised, Controlled 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.

Read the 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.

Being tested
The intervention group, control group
Keywords
quality of life, feeling of security, costs, multiprofessional team, geriatric competence
Medical subject headings
Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The intervention groupProcedure or surgery

    Also called Geriatric care team

    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 groupProcedure or surgery

    No intervention

Study groups in NCT01446757
Study groupRoleWhat they receive
The intervention groupExperimentalThe 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.
Receives: Procedure: The intervention group
Control groupPlacebo comparatorThe 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.
Receives: Procedure: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospitalisation

    Number of hospitalisations and in-care stays during the trial

    Measured: 24 months

  2. 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.

    Measured: 24 months

Secondary outcomes (11)

  1. Cognition

    Cognition is assessed by the Mini-Mental State Examination

    Measured: 0 and 24 months

  2. 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.

    Measured: 0 and 24 months

  3. Depression

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

    Measured: 0 and 24 months

  4. 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)

    Measured: 0 and 24 months

  5. Nutrition

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

    Measured: 0 and 24 months

  6. Activities of Daily Living

    Barthels index

    Measured: 0 and 24 months

  7. Falls

    the patient is asked about falls in the last 6 months

    Measured: 0 and 24 months

  8. 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

    Measured: 24 months

  9. Feeling of security of the patient

    Questionnaire

    Measured: 0, 12 and 24 months

  10. Feeling of security of the relatives

    Questionnaire

    Measured: 0, 12 and 24 months

  11. Quality of life of relatives

    Questionnaire

    Measured: 0, 12 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2013
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
383 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01446757
Sponsor's protocol ID
2011/41-31
Acronym
AGE-FIT
Status last verified
Mar 2014
First submitted
19 Sep 2011
Last updated
1 Apr 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31277674

  • 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.

    PubMed 29386007

  • 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.

    PubMed 25703450

Questions about this trial

What is this clinical trial studying?

A study testing The intervention group in people with Frail Elderly and Deaths, run by Linkoeping University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospitalisation (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01446757, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2014.

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