Acute Medical ConditionsACCESSNCT02422849
Acute Combined Care for Seniors in Southern Denmark
A study testing hospital specialist and General Practitioner in people with Acute Medical Conditions, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
the elderly population (+ 65 years) is increasing. Acute medical conditions often leads to hospital admissions in this age group. However hospital admission is linked to adverse events. like confusion, medication errors or new infections. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Medical Conditions
- What is being tested?
- hospital specialist and General Practitioner
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Jun 2015
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute medical condition requiring immediate intervention.
- home care capacity limit reached
Who cannot join
- GP not available next days
- absolutely admission requiring condition
- no informed consent obtainable
- nursing home resident
Trial locations and contacts
1 site in 1 country.
About this study
the elderly population (+ 65 years) is increasing. Acute medical conditions often leads to hospital admissions in this age group. However hospital admission is linked to adverse events. like confusion, medication errors or new infections.
the ACCESS project aims to examine alternatives to acute admissions for senior medical patients.
the aims are:
- How many patients will be admitted to hospital due to acute medical conditions if cared for by their own General Practitioner (GP) versus a hospital intern specialist ?
- how many patients will be admitted to hospital due to acute medical conditions if cared for by acute team in their home versus in specialised care centres ?
- Conditions
- Acute Medical Conditions
- Being tested
- hospital specialist, General Practitioner
- Keywords
- Patient admission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hospital specialistOther
General PractitionerOther
| Study group | Role | What they receive |
|---|---|---|
| own GP | Other | The patient is cared for by own General Practitioner in the acute stage Receives: Other: General Practitioner |
| Hospital specialist | Other | The patient is cared for by a hospital specialist in the acute stage Receives: Other: hospital specialist |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with hospital admission
Measured: 3 months after inclusion
Secondary outcomes (4)
change from baseline in De Morton Mobility Index (DEMMI)
Measured: 3 months after inclusion
change from baseline in quality of life (EQ5D scale)
Measured: 3 months after inclusion
change from baseline in Orientation Memory-Concentration (OMC)
Measured: 3 months after inclusion
patient and relatives satisfaction questionnaire
Measured: 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startNov 2013
- Primary completionFeb 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Medical ConditionsStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Backer Mogensen, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422849
- Sponsor's protocol ID
- SHS-ED-01-2013
- Acronym
- ACCESS
- Status last verified
- Feb 2016
- First submitted
- 27 Mar 2015
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Combined Care for Seniors in Southern Denmark
- ClinicalTrials.gov ID
- NCT02422849
- Acronym / sponsor ID
- ACCESS / SHS-ED-01-2013
- Conditions
- Acute Medical Conditions
- Keywords
- Patient admission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Apr 2015 (estimated)
- 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.
the elderly population (+ 65 years) is increasing. Acute medical conditions often leads to hospital admissions in this age group. However hospital admission is linked to adverse events. like confusion, medication errors or new infections.
the ACCESS project aims to examine alternatives to acute admissions for senior medical patients.
the aims are:
- How many patients will be admitted to hospital due to acute medical conditions if cared for by their own General Practitioner (GP) versus a hospital intern specialist ?
- how many patients will be admitted to hospital due to acute medical conditions if cared for by acute team in their home versus in specialised care centres ?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| own GP | Other | Other: General PractitionerThe patient is cared for by own General Practitioner in the acute stage |
| Hospital specialist | Other | Other: hospital specialistThe patient is cared for by a hospital specialist in the acute stage |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute medical condition requiring immediate intervention.
- home care capacity limit reached
Key exclusion criteria (4 listed)
- GP not available next days
- absolutely admission requiring condition
- no informed consent obtainable
- nursing home resident
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 |
|---|---|---|
| hospital specialist | Other | Hospital specialist |
| General Practitioner | Other | own GP |
Primary outcome
number of participants with hospital admission
Time frame: 3 months after inclusion
4 secondary outcomes
change from baseline in De Morton Mobility Index (DEMMI)
Time frame: 3 months after inclusion
change from baseline in quality of life (EQ5D scale)
Time frame: 3 months after inclusion
change from baseline in Orientation Memory-Concentration (OMC)
Time frame: 3 months after inclusion
patient and relatives satisfaction questionnaire
Time frame: 3 months after inclusion
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 17 Feb 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hospital specialist and General Practitioner in people with Acute Medical Conditions, run by University of Southern Denmark at 1 site in Denmark.
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 4 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 17 Feb 2016. 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 Denmark. 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?
number of participants with hospital admission (time frame: 3 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2016.