Frail Elderly SyndromeGAOPSNCT03751319
Geriatric Assessment and Intervention for Older Patients With Frailty in the Emergency Department
A study testing CGA in people with Frail Elderly Syndrome and Patient Admission, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Comprehensive Geriatric Assessment (CGA) is an established approach for better detection of frailty-related problems and includes individualized treatment plan with multi-discipline supportive and treating measures for the older frailty patients. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Patient Admission, Hospital Readmission
- What is being tested?
- CGA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteFinland
- Study dates
- 11 Dec 2018to 2 Jul 2021
- 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
- Age of minimum 75 years
- "Clinical Frailty Scale" minimum 4 estimated at the arrival to the ED by nurse
Who cannot join
- Non-resident of the counties (City of Espoo, Kirkkonummi, Kauniainen) of the hospital district.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Geriatric Assessment and Intervention for Older Patients With Frailty in the Emergency Department. Randomized Controlled Trial
Comprehensive Geriatric Assessment (CGA) is an established approach for better detection of frailty-related problems and includes individualized treatment plan with multi-discipline supportive and treating measures for the older frailty patients. However, there is limited evidence of feasibility and efficacy of the CGA when provided in the emergency department setting.
In the GAOPS-study the efficacy of the CGA in emergency department setting will be studied by randomized controlled study protocol. We aim to study if the CGA provided in the ED is feasible, safe and efficient method when added with standard emergency care for older frail patients.
- Conditions
- Frail Elderly Syndrome, Patient Admission, Hospital Readmission, Length of Stay, Fall, Quality of Life
- Being tested
- CGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGAOther
Comprehensive Geriatric Assessment
| Study group | Role | What they receive |
|---|---|---|
| Standard Emergency Care + CGA | Active comparator | Standard Care is provided for the acute condition as usual by the ED personnel. Besides the standard care provided by ED personnel, patients are systemically screened and assessed by physician trained for geriatrics or geriatric emergency medicine. Geriatric multi-discipline treatment plan and recommendations are given if suitable for the case. Receives: Other: CGA |
| Standard Emergency Care | No intervention | Standard Care is provided for the acute condition as usual by the ED personnel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulated Length of Stay
Cumulated stay (days) in hospital wards (university hospital and community hospital) including all admissions during the follow-up.
Measured: Day 365
Secondary outcomes (5)
Admissions
Number of admissions to the hospital wards (university hospital and community hospital) during the follow-up.
Measured: Day 30, Day 365
Admission rate
Proportion of admitted patients (university hospital or community hospital ward) from the index ED-visits.
Measured: Day 0
Readmissions in the ED
Re-visits to the ED after the index-visit.
Measured: Hour 72, Day 30, Day 365
Living at home
Proportion of the patients living at home.
Measured: Day 365
Quality of Life
Change of the quality of life during one year follow-up using the standardized questionnaire EuroQol EQ-5D-5L. Measured value is the index value defined by the EuroQol group.
Measured: Day 0, Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start11 Dec 2018
- Primary completion7 Jun 2020
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- City of Espoo, University of Helsinki
- Responsible party
- Principal investigator, Janne Alakare, Helsinki University Central Hospital
- Investigators
- Veli-Pekka Harjola, Study director, Department of Emergency Medicine and Services, Helsinki University HospitalJanne Alakare, MD, Principal investigator, Department of Emergency Medicine and Services, Helsinki University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751319
- Sponsor's protocol ID
- TYH2018304
- Other IDs
- HUS1171/2018
- Acronym
- GAOPS
- Status last verified
- Aug 2021
- First submitted
- 18 Nov 2018
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alakare J, Kemp K, Strandberg T, Castren M, Jakovljevic D, Tolonen J, Harjola VP. Systematic geriatric assessment for older patients with frailty in the emergency department: a randomised controlled trial. BMC Geriatr. 2021 Jul 2;21(1):408. doi: 10.1186/s12877-021-02351-2.
PubMed 34215193
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Assessment and Intervention for Older Patients With Frailty in the Emergency Department. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03751319
- Acronym / sponsor ID
- GAOPS / TYH2018304
- Conditions
- Frail Elderly Syndrome, Patient Admission, Hospital Readmission, Length of Stay, Fall, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- City of Espoo, University of Helsinki
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 7 Jun 2020 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comprehensive Geriatric Assessment (CGA) is an established approach for better detection of frailty-related problems and includes individualized treatment plan with multi-discipline supportive and treating measures for the older frailty patients. However, there is limited evidence of feasibility and efficacy of the CGA when provided in the emergency department setting.
In the GAOPS-study the efficacy of the CGA in emergency department setting will be studied by randomized controlled study protocol. We aim to study if the CGA provided in the ED is feasible, safe and efficient method when added with standard emergency care for older frail patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Standard Emergency Care + CGA | Active comparator | Other: CGAStandard Care is provided for the acute condition as usual by the ED personnel. Besides the standard care provided by ED personnel, patients are systemically screened and assessed by physician trained for geriatrics or geriatric emergency medicine. Geriatric multi-discipline treatment plan and recommendations are given if suitable for the case. |
| Standard Emergency Care | No intervention | –Standard Care is provided for the acute condition as usual by the ED personnel. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age of minimum 75 years
- "Clinical Frailty Scale" minimum 4 estimated at the arrival to the ED by nurse
Key exclusion criteria (1 listed)
- Non-resident of the counties (City of Espoo, Kirkkonummi, Kauniainen) of the hospital district.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGAComprehensive Geriatric Assessment | Other | Standard Emergency Care + CGA |
Primary outcome
Cumulated Length of Stay
Time frame: Day 365
Cumulated stay (days) in hospital wards (university hospital and community hospital) including all admissions during the follow-up.
5 secondary outcomes
Admissions
Time frame: Day 30, Day 365
Admission rate
Time frame: Day 0
Readmissions in the ED
Time frame: Hour 72, Day 30, Day 365
Living at home
Time frame: Day 365
Quality of Life
Time frame: Day 0, Day 365
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Results publication: PubMed 34215193Alakare J, Kemp K, Strandberg T, Castren M, Jakovljevic D, Tolonen J, Harjola VP. Systematic geriatric assessment for older patients with frailty in the emergency department: a randomised controlled trial. BMC Geriatr. 2021 Jul 2;21(1):408. doi: 10.1186/s12877-021-02351-2.
- Alakare, J., Kemp, K., Strandberg, T. et al. Systematic geriatric assessment for older patients with frailty in the emergency department: a randomised controlled trial. BMC Geriatr 21, 408 (2021). https://doi.org/10.1186/s12877-021-02351-2Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veli-Pekka Harjola study director
Department of Emergency Medicine and Services, Helsinki University Hospital
Janne Alakare, MD principal investigator
Department of Emergency Medicine and Services, Helsinki University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGA in people with Frail Elderly Syndrome and Patient Admission, run by Helsinki University Central Hospital at 1 site in Finland.
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 2 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 11 Aug 2021. 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 Finland. 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. 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?
Cumulated Length of Stay (time frame: Day 365). 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 NCT03751319, which also lists 1 linked publication.
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 11 Aug 2021.