NCT02923843

Brief Summary

Frailty and multimorbidity is one of the biggest challenges of todays health care due to the demographic development with more and more elderly surviving many diseases that was mortal just a few decades ago. Health care in Sweden is one of the best in the world, yet many frail older people do not receive appropriate health care. Several reports have described a fragmented care with lack of good quality due to lack of a holistic view on the patient and her situation. At the same time the care given is costly and ineffective with a lack of continuity. Additionally, there are a lack of hospital beds in Sweden due to the ageing population and a cut down of beds in the last decades. There is though a method, Comprehensive Geriatric Assessment (CGA), where studies have shown many benefits for older patients including less need of hospital beds, better functional outcomes and a better chance of living at home after an Acute Hospital Discharge, but this method is not much used in Sweden. The aim of this study is to show that CGA in an Out-patient Care Setting save hospital beds without decreasing the quality of care measured by sustained functional capacity. Other parameters to be evaluated are mortality, degree of frailty, health economy, quality of life, and cognition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 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

First Submitted

Initial submission to the registry

September 26, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

3.6 years

First QC Date

September 26, 2016

Last Update Submit

January 12, 2021

Conditions

Keywords

frailtycomprehensive geriatric assessment

Outcome Measures

Primary Outcomes (1)

  • Days in hospital

    Register data

    24 months

Secondary Outcomes (21)

  • Short Physical Performance Battery

    12 months

  • Short Physical Performance Battery

    24 months

  • ADL-staircase (21)

    12 months

  • ADL-staircase (21)

    24 months

  • Frailty phenotype - Unintentional weight loss

    24 months

  • +16 more secondary outcomes

Study Arms (2)

intervention

EXPERIMENTAL

Comprehensive Geriatric Assessment

Other: Comprehensive Geriatric Assessment

control

NO INTERVENTION

Standard care

Interventions

The CGA is person-centered and unique for each patient, but is based on the core elements such as socio-demographic background, social network, health and medical history, medications, functional status, cognitive status, nutritional status, somatic status and psychosocial status including depression, providing a comprehensive assessment tailored for each person.

intervention

Eligibility Criteria

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

You may qualify if:

  • Years
  • visits in the Emergency Room (ER) during the previous 18 months
  • diagnoses according to ICD-10.

You may not qualify if:

  • people living outside the Municipalities of Helsingborg, Åstorp, Bjuv and Höganäs municipality
  • living in nursing homes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsingborg Hospital

Helsingborg, 25167, Sweden

Location

Related Publications (11)

  • Wieland D, Hirth V. Comprehensive geriatric assessment. Cancer Control. 2003 Nov-Dec;10(6):454-62. doi: 10.1177/107327480301000603.

    PMID: 14652521BACKGROUND
  • Prestmo A, Hagen G, Sletvold O, Helbostad JL, Thingstad P, Taraldsen K, Lydersen S, Halsteinli V, Saltnes T, Lamb SE, Johnsen LG, Saltvedt I. Comprehensive geriatric care for patients with hip fractures: a prospective, randomised, controlled trial. Lancet. 2015 Apr 25;385(9978):1623-33. doi: 10.1016/S0140-6736(14)62409-0. Epub 2015 Feb 5.

    PMID: 25662415BACKGROUND
  • Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.

    PMID: 15031310BACKGROUND
  • Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.

    PMID: 23395245BACKGROUND
  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PMID: 11253156BACKGROUND
  • Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.

    PMID: 23764209BACKGROUND
  • Warnier RM, van Rossum E, van Velthuijsen E, Mulder WJ, Schols JM, Kempen GI. Validity, Reliability and Feasibility of Tools to Identify Frail Older Patients in Inpatient Hospital Care: A Systematic Review. J Nutr Health Aging. 2016 Feb;20(2):218-30. doi: 10.1007/s12603-015-0567-z.

    PMID: 26812520BACKGROUND
  • Jones DM, Song X, Rockwood K. Operationalizing a frailty index from a standardized comprehensive geriatric assessment. J Am Geriatr Soc. 2004 Nov;52(11):1929-33. doi: 10.1111/j.1532-5415.2004.52521.x.

    PMID: 15507074BACKGROUND
  • Ekdahl AW, Alwin J, Eckerblad J, Husberg M, Jaarsma T, Mazya AL, Milberg A, Krevers B, Unosson M, Wiklund R, Carlsson P. Long-Term Evaluation of the Ambulatory Geriatric Assessment: A Frailty Intervention Trial (AGe-FIT): Clinical Outcomes and Total Costs After 36 Months. J Am Med Dir Assoc. 2016 Mar 1;17(3):263-8. doi: 10.1016/j.jamda.2015.12.008. Epub 2016 Jan 21.

    PMID: 26805750BACKGROUND
  • 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: 25703450BACKGROUND
  • Ekdahl AW, Axmon A, Sandberg M, Steen Carlsson K. Is care based on comprehensive geriatric assessment with mobile teams better than usual care? A study protocol of a randomised controlled trial (The GerMoT study). BMJ Open. 2018 Oct 10;8(10):e023969. doi: 10.1136/bmjopen-2018-023969.

MeSH Terms

Conditions

Frailty

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth StatusDemographyPopulation CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Anne W Ekdahl

    Region Skåne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2016

First Posted

October 5, 2016

Study Start

November 1, 2016

Primary Completion

June 15, 2020

Study Completion

June 15, 2020

Last Updated

January 13, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Locations