Functionally-Impaired ElderlyNCT02062541
Effect of Functional Assessment and Immediate Rehabilitation of ED Admitted Elderly With Reduced Functional Performance
A study testing Funct. assessment+fast rehabilitation, Funct. assessment+usual rehabilitation and usual assessment+fast rehabilitation in people with Functionally-Impaired Elderly, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Background: Illness and hospitalisation, even of short duration, pose separate risks for permanently reduced functional performance in elderly medical patients. Functional assessment in the acute pathway will ensure early detection of declining performance and form the basis for mobilisation during hospitalisation and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Functionally-Impaired Elderly
- What is being tested?
- Funct. assessment+fast rehabilitation, Funct. assessment+usual rehabilitation and usual assessment+fast rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2015to Jan 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- medical patients of 65 years of age or older admitted to the ED
- Can speak and understand Danish
- Resident in either of the two included municipalities
- Can report personal data and decide on consent
- Are able to sit on an chair and perform ≤ 9 repetitions at the 30-s. chair-stand test
Who cannot join
- Patients suffering from a progressive neurological or cognitive deficit or disease.
- Patients ordinarily unable to walk
Trial locations and contacts
1 site in 1 country.
About this study
Background: Illness and hospitalisation, even of short duration, pose separate risks for permanently reduced functional performance in elderly medical patients. Functional assessment in the acute pathway will ensure early detection of declining performance and form the basis for mobilisation during hospitalisation and subsequent rehabilitation. For optimal results rehabilitation should begin immediately after discharge.
The aim of this study is to investigate the effect of a systematic functional assessment in the emergency departments (ED) of elderly medical patients with reduced functional performance when combined with immediate post-discharge rehabilitation.
Read more
Method/design: The study is a two-way factorial randomised clinical trial. Participants will be recruited among patients admitted to the ED who are above 65 years of age with reduced functional performance. Patients will be randomly assigned to one of four groups: 1) functional assessment and immediate rehabilitation; 2) functional assessment and usual rehabilitation; 3) usual assessment and immediate rehabilitation; 4) usual assessment and usual rehabilitation.
Primary outcome: 30-second chair-stand test administered at admission and two weeks after discharge.
We hypothesise that such assessment in the ED or/and immediate rehabilitation will result in sustained or improved performance in comparison to regimen in which neither of these interventions are offered.
- Conditions
- Functionally-Impaired Elderly
- Being tested
- Funct. assessment+fast rehabilitation, Funct. assessment+usual rehabilitation, usual assessment+fast rehabilitation
- Keywords
- functional assessment, rehabilitation, cross-sectorial cooperation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Funct. assessment+fast rehabilitationOther
Funct. assessment+usual rehabilitationOther
usual assessment+fast rehabilitationOther
| Study group | Role | What they receive |
|---|---|---|
| Funct. assessment+fast rehabilitation | Experimental | Funct. assessment+fast rehabilitation Receives: Other: Funct. assessment+fast rehabilitation |
| Funct. assessment+usual rehabilitation | Experimental | Funct. assessment+usual rehabilitation Receives: Other: Funct. assessment+usual rehabilitation |
| usual assessment+fast rehabilitation | Experimental | usual assessment+fast rehabilitation Receives: Other: usual assessment+fast rehabilitation |
| usual assessment+usual rehabilitation | No intervention | usual assessment+usual rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-second-chair-stand test
Measured: up to 14 days after admission date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startJun 2015
- Primary completionJan 2017
- Study completionJan 2017
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 Functionally-Impaired ElderlyStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Sygehus Lillebaelt
- Responsible party
- Principal investigator, Christian Backer Mogensen, University of Southern Denmark
- Investigators
- Christian B Mogensen, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062541
- Sponsor's protocol ID
- SLB-ED-02-2014
- Status last verified
- Feb 2017
- First submitted
- 12 Feb 2014
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bruun IH, Norgaard B, Maribo T, Schiottz-Christensen B, Mogensen CB. The effect on physical performance of a functional assessment and immediate rehabilitation of acutely admitted elderly patients with reduced functional performance: the design of a randomised clinical trial. BMJ Open. 2014 Jun 17;4(6):e005252. doi: 10.1136/bmjopen-2014-005252.
PubMed 24939812
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Functional Assessment and Immediate Rehabilitation of ED Admitted Elderly With Reduced Functional Performance
- ClinicalTrials.gov ID
- NCT02062541
- Acronym / sponsor ID
- SLB-ED-02-2014
- Conditions
- Functionally-Impaired Elderly
- Keywords
- functional assessment, rehabilitation, cross-sectorial cooperation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Sygehus Lillebaelt
- Study start
- Jun 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Feb 2014 (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.
Background: Illness and hospitalisation, even of short duration, pose separate risks for permanently reduced functional performance in elderly medical patients. Functional assessment in the acute pathway will ensure early detection of declining performance and form the basis for mobilisation during hospitalisation and subsequent rehabilitation. For optimal results rehabilitation should begin immediately after discharge.
The aim of this study is to investigate the effect of a systematic functional assessment in the emergency departments (ED) of elderly medical patients with reduced functional performance when combined with immediate post-discharge rehabilitation.
Method/design: The study is a two-way factorial randomised clinical trial. Participants will be recruited among patients admitted to the ED who are above 65 years of age with reduced functional performance. Patients will be randomly assigned to one of four groups: 1) functional assessment and immediate rehabilitation; 2) functional assessment and usual rehabilitation; 3) usual assessment and immediate rehabilitation; 4) usual assessment and usual rehabilitation.
Primary outcome: 30-second chair-stand test administered at admission and two weeks after discharge.
We hypothesise that such assessment in the ED or/and immediate rehabilitation will result in sustained or improved performance in comparison to regimen in which neither of these interventions are offered.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Funct. assessment+fast rehabilitation | Experimental | Other: Funct. assessment+fast rehabilitationFunct. assessment+fast rehabilitation |
| Funct. assessment+usual rehabilitation | Experimental | Other: Funct. assessment+usual rehabilitationFunct. assessment+usual rehabilitation |
| usual assessment+fast rehabilitation | Experimental | Other: usual assessment+fast rehabilitationusual assessment+fast rehabilitation |
| usual assessment+usual rehabilitation | No intervention | –usual assessment+usual rehabilitation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- medical patients of 65 years of age or older admitted to the ED
- Can speak and understand Danish
- Resident in either of the two included municipalities
- Can report personal data and decide on consent
- Are able to sit on an chair and perform ≤ 9 repetitions at the 30-s. chair-stand test
Key exclusion criteria (2 listed)
- Patients suffering from a progressive neurological or cognitive deficit or disease.
- Patients ordinarily unable to walk
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 |
|---|---|---|
| Funct. assessment+fast rehabilitation | Other | Funct. assessment+fast rehabilitation |
| Funct. assessment+usual rehabilitation | Other | Funct. assessment+usual rehabilitation |
| usual assessment+fast rehabilitation | Other | usual assessment+fast rehabilitation |
Primary outcome
30-second-chair-stand test
Time frame: up to 14 days after admission date
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 2 Feb 2017.
- Derived from this study: PubMed 24939812Bruun IH, Norgaard B, Maribo T, Schiottz-Christensen B, Mogensen CB. The effect on physical performance of a functional assessment and immediate rehabilitation of acutely admitted elderly patients with reduced functional performance: the design of a randomised clinical trial. BMJ Open. 2014 Jun 17;4(6):e005252. doi: 10.1136/bmjopen-2014-005252.
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.
Christian B Mogensen, PhD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Funct. assessment+fast rehabilitation, Funct. assessment+usual rehabilitation and usual assessment+fast rehabilitation in people with Functionally-Impaired Elderly, 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 5 inclusion and 2 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 2 Feb 2017. 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?
30-second-chair-stand test (time frame: up to 14 days after admission date). 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 NCT02062541, 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 2 Feb 2017.