Geriatric DisorderNCT01949831
The Effect of Systematic Assessment of Functional Ability, Development of Rehabilitation Plan and Follow-up at Home for Elderly Medical Patients
A study testing Assessment of functional ability in combination with follow-up at home in people with Geriatric Disorder, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to examine the effect of systematic assessment of functional ability, development of rehabilitation plan and follow-up at home for elderly medical patient's risk of readmission. The effect of the intervention is examined in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Disorder
- What is being tested?
- Assessment of functional ability in combination with follow-up at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Feb 2014
- 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
- Patients admitted to, Medical Visitation Section (MVA) Aarhus University Hospital
- aged 65+
- resident in City of Aarhus.
Who cannot join
- Patients admitted from a psychiatric institution or nursing home
- patients without walking ability
- patients who do not speak or read Danish
- terminally ill patients
- patients transferred to other hospital departments
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to examine the effect of systematic assessment of functional ability, development of rehabilitation plan and follow-up at home for elderly medical patient's risk of readmission. The effect of the intervention is examined in a randomized controlled trial.
- Conditions
- Geriatric Disorder
- Being tested
- Assessment of functional ability in combination with follow-up at home
- Keywords
- functional assessment, acute care, older medical patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of functional ability in combination with follow-up at homeOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care |
| Functional assessment | Experimental | Assessment of functional ability in combination with follow-up at home Receives: Other: Assessment of functional ability in combination with follow-up at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-admission
*Primary outcome was originally set to readmissions within 26 weeks but due to clerical error it has been written as 30 days. The error has now been corrected.
Measured: Re-admission in 26 weeks
Secondary outcomes (3)
Mortality
Measured: 30 day mortality
Functional ability
Functional ability measured with World Health Organization Disability Assessment Schedule (WHODAS 2.0) and Barthel-20
Measured: 4 and 26 weeks after intervention
Re-admission
Measured: Re-admission within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
Why it stopped: Due to inclusion problems (not recruting enough participants) recruiting participants has halted prematurely and will not resume.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric DisorderStudies of the same condition, open and under way.
- More trials run by Aarhus University 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- VIA University College, Institute of public health, department of nursing sciences, Århus University, Denmark
- Responsible party
- Principal investigator, Louise Møldrup Nielsen, Aarhus University Hospital
- Investigators
- Hans Kirkegaard, Professor, Principal investigator, Center for Acute research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949831
- Sponsor's protocol ID
- MVAprojekt
- Status last verified
- Feb 2014
- First submitted
- 13 Sep 2013
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Systematic Assessment of Functional Ability, Development of Rehabilitation Plan and Follow-up at Home for Elderly Medical Patients
- ClinicalTrials.gov ID
- NCT01949831
- Acronym / sponsor ID
- MVAprojekt
- Conditions
- Geriatric Disorder
- Keywords
- functional assessment, acute care, older medical patients
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to inclusion problems (not recruting enough participants) recruiting participants has halted prematurely and will not resume.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- VIA University College, Institute of public health, department of nursing sciences, Århus University, Denmark
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- First posted
- 25 Sep 2013 (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 aim of this study is to examine the effect of systematic assessment of functional ability, development of rehabilitation plan and follow-up at home for elderly medical patient's risk of readmission. The effect of the intervention is examined in a randomized controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care |
| Functional assessment | Experimental | Other: Assessment of functional ability in combination with follow-up at homeAssessment of functional ability in combination with follow-up at home |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients admitted to, Medical Visitation Section (MVA) Aarhus University Hospital
- aged 65+
- resident in City of Aarhus.
Key exclusion criteria (5 listed)
- Patients admitted from a psychiatric institution or nursing home
- patients without walking ability
- patients who do not speak or read Danish
- terminally ill patients
- patients transferred to other hospital departments
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 |
|---|---|---|
| Assessment of functional ability in combination with follow-up at home | Other | Functional assessment |
Primary outcome
Re-admission
Time frame: Re-admission in 26 weeks
*Primary outcome was originally set to readmissions within 26 weeks but due to clerical error it has been written as 30 days. The error has now been corrected.
3 secondary outcomes
Mortality
Time frame: 30 day mortality
Functional ability
Time frame: 4 and 26 weeks after intervention
Re-admission
Time frame: Re-admission within 30 days
Results and safety
The study was stopped early (reason given: Due to inclusion problems (not recruting enough participants) recruiting participants has halted prematurely and will not resume.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
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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.
Hans Kirkegaard, Professor principal investigator
Center for Acute research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of functional ability in combination with follow-up at home in people with Geriatric Disorder, run by Aarhus University Hospital 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 3 Mar 2014. 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 was stopped early (reason given: Due to inclusion problems (not recruting enough participants) recruiting participants has halted prematurely and will not resume.). Results are not available in the source record.
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?
Re-admission (time frame: Re-admission in 26 weeks). 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 3 Mar 2014.