Elderly Clinical Trial
Official title:
Are Care Given by a Geriatric Hospital-Based Out Patient-Care Team Better Than Usual Care? - a Randomised Controlled Trial (The GerOP-Ca-trial)
NCT number | NCT02923843 |
Other study ID # | HBG-AWE-01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | June 15, 2020 |
Verified date | January 2021 |
Source | Region Skane |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 450 |
Est. completion date | June 15, 2020 |
Est. primary completion date | June 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years and older |
Eligibility | Inclusion Criteria: - 75 Years - 3 visits in the Emergency Room (ER) during the previous 18 months - 3 diagnoses according to ICD-10. Exclusion Criteria: - people living outside the Municipalities of Helsingborg, Åstorp, Bjuv and Höganäs municipality - living in nursing homes |
Country | Name | City | State |
---|---|---|---|
Sweden | Helsingborg Hospital | Helsingborg |
Lead Sponsor | Collaborator |
---|---|
Region Skane |
Sweden,
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. Review. Erratum in: Lancet. 2013 Oct 19;382(9901):1328. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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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. — View Citation
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. — View Citation
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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. Review. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Days in hospital | Register data | 24 months | |
Secondary | Short Physical Performance Battery | Guralnik, et al. Lower Extremity Function and Subsequent Disability: Consistency Across Studies, Predictive Models, and Value of Gait Speed Alone Compared With the Short Physical Performance Battery. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences. | 12 months | |
Secondary | Short Physical Performance Battery | Guralnik, et al. Lower Extremity Function and Subsequent Disability: Consistency Across Studies, Predictive Models, and Value of Gait Speed Alone Compared With the Short Physical Performance Battery. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences. | 24 months | |
Secondary | ADL-staircase (21) | Ability to perform activities of daily living | 12 months | |
Secondary | ADL-staircase (21) | Ability to perform activities of daily living | 24 months | |
Secondary | Frailty phenotype - Unintentional weight loss | =5% weightloss previous year | 24 months | |
Secondary | Frailty phenotype - Exhaustion | Assessed by two questions from the Centre for Epidemiologic Studies-Depression Scale. (IPAQ-S). A score of 2 or 3 for either of these questions is defined as indicating a criterion of frailty or exhaustion. | 24 months | |
Secondary | Frailty phenotype - low physical activity | 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). "Low activity" is a criterion for frailty | 24 months | |
Secondary | Frailty phenotype - 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. More than 5 seconds to cover a 4-meter course is a criterion for frailty | 24 months | |
Secondary | Frailty phenotype - weakness | Is assessed by maximal grip strength in kilograms using the Jamar handheld dynamometer twice on the dominant hand. Cut-off values for males and females used by Fried et al 2001 are used to define weak grip strength | 24 months | |
Secondary | Clinical Frailty Scale | frailty level judged by clinical assessment | 12 months | |
Secondary | Clinical Frailty Scale | frailty level judged by clinical assessment | 24 months | |
Secondary | mortality | register data | 12 months | |
Secondary | mortality | register data | 24 months | |
Secondary | MoCA | Montreal Cognitive assessment | 12 months | |
Secondary | MoCA | Montreal Cognitive assessment | 24 months | |
Secondary | EQ-5D | quality of life | 12 months | |
Secondary | EQ-5D | quality of life | 24 months | |
Secondary | health care consumption | register data | 12 months | |
Secondary | health care consumption | register data | 24 months | |
Secondary | consumption av home care | register data - number of hours og home help services | 12 months | |
Secondary | consumption av home care | register data - days spent in nursing home | 24 months |
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