NCT01446757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
383

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 1, 2014

Status Verified

March 1, 2014

Enrollment Period

2.8 years

First QC Date

September 19, 2011

Last Update Submit

March 29, 2014

Conditions

Frail ElderlyDeaths

Keywords

quality of lifefeeling of securitycostsmultiprofessional teamgeriatric competence

Outcome Measures

Primary Outcomes (2)

  • Hospitalisation

    Number of hospitalisations and in-care stays during the trial

    24 months

  • 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

Secondary Outcomes (11)

  • Cognition

    0 and 24 months

  • Symptoms

    0 and 24 months

  • Depression

    0 and 24 months

  • Health related quality of life

    0 and 24 months

  • Nutrition

    0 and 24 months

  • +6 more secondary outcomes

Study Arms (2)

The intervention group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

The intervention groupPROCEDURE

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.

Also known as: Geriatric care team
The intervention group
control groupPROCEDURE

No intervention

Control group

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Geriatric Medicine

Norrköping, 60182, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 31277674DERIVED

  • 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.

    PMID: 29386007DERIVED

  • 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.

    PMID: 25703450DERIVED

MeSH Terms

Conditions

Death

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Anne W Ekdahl, Physisian

    Linkopeing University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant, geriatrician

Study Record Dates

First Submitted

September 19, 2011

First Posted

October 5, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

April 1, 2014

Record last verified: 2014-03

Locations

SE(1)