FrailtyNCT02094040
Municipality-based Post-discharge Follow-up Visits
A study testing Receive municipality-based follow-up visit in people with Frailty and Readmission, run by Holbaek Sygehus at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether discharge follow-up visit by primary physician and community-based nurse affects the risk of early re-hospitalisation among high risk older people discharged from a medical ward. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Readmission, Transition
- What is being tested?
- Receive municipality-based follow-up visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 531 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2012to Dec 2013
- 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
- Patient geography (The participant live in; Holbæk Kommune, Odsherred Kommune or Kalundborg Kommune.)
- Discharged from medical ward Holbæk Sygehus.
- Frailty (Rated by following criterion: dementia or a minimum of two of the following conditions; two or more hospitalisations within 12 month prior to follow up, los of physical function, treatment of two or more concurrent medical and/or surgical conditions, psychiatric disease, multi-pharmacy of more than 6 prescription medication, suspicious of congenital disturbances, substance abuse problem, disadvantaged social network, need for increasing home care following index hospitalization.)
Who cannot join
- Not discharged to home (If the patient are not discharged to home.)
- No written consent (If the patient does not wish to participate / written consent are not signed.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Municipality-based Post-discharge Follow-up Visit Including the Primary Physician on Early Re-hospitalization in High Risk People of 65+ Years. A Randomised Controlled Trial.
The purpose of this study is to determine whether discharge follow-up visit by primary physician and community-based nurse affects the risk of early re-hospitalisation among high risk older people discharged from a medical ward.
- Conditions
- Frailty, Readmission, Transition, Primary Care
- Being tested
- Receive municipality-based follow-up visit
- Keywords
- frailty, readmission, transition, discharge, primary care
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receive municipality-based follow-up visitBehavioural
Also called Intervention group
Systematic electronic referral from hospital to municipality of high risk people at discharge from a medical ward. Contact from municipality service to primary physician and citizen, to arrange first home visit within 7 days with focus on: medication, rehabilitation plan and health care appointments, functional level and need for further health care initiatives. The visit is concluded by planning of further visits (up till tree) and division of responsibilities between primary physician and the municipality service.
| Study group | Role | What they receive |
|---|---|---|
| Follow-up visit | Experimental | Receive municipality-based follow-up visit including primary physician. Receives: Behavioral: Receive municipality-based follow-up visit |
| Usual care | No intervention | Does not receive follow-up visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-admission
The primary outcome is re-hospitalisation rate within 30 days from discharge. Data is obtained from the official register of danish patients (Landspatientregistret).
Measured: Within 30 days from discharge
Secondary outcomes (1)
Long-term hospitalization rate
Secondary outcome concerns hospitalization rate measured at 30 and 180 days post discharge. Data is obtained from the official register of Danish patients (Landspatientregistret).
Measured: Within 180 days from discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startFeb 2012
- Primary completionDec 2013
- Study completionDec 2013
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 FrailtyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 531 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- Region Sjælland, Danish Institute for Public Health
- Responsible party
- Sponsor
- Investigators
- Thomas Gjørup, Principal investigator, Medicinsk Afdeling, Holbæk Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094040
- Sponsor's protocol ID
- 3800H0.52-0059
- Status last verified
- Mar 2014
- First submitted
- 12 Mar 2014
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Thygesen LC, Fokdal S, Gjorup T, Taylor RS, Zwisler AD; Prevention of Early Readmission Research Group. Can municipality-based post-discharge follow-up visits including a general practitioner reduce early readmission among the fragile elderly (65+ years old)? A randomized controlled trial. Scand J Prim Health Care. 2015 Jun;33(2):65-73. doi: 10.3109/02813432.2015.1041831. Epub 2015 Jun 10.
PubMed 26059872
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Municipality-based Post-discharge Follow-up Visit Including the Primary Physician on Early Re-hospitalization in High Risk People of 65+ Years. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT02094040
- Acronym / sponsor ID
- 3800H0.52-0059
- Conditions
- Frailty, Readmission, Transition, Primary Care
- Keywords
- frailty, readmission, transition, discharge, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 531 participants (actual)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Collaborators
- Region Sjælland, Danish Institute for Public Health
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Mar 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.
The purpose of this study is to determine whether discharge follow-up visit by primary physician and community-based nurse affects the risk of early re-hospitalisation among high risk older people discharged from a medical ward.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow-up visit | Experimental | Behavioral: Receive municipality-based follow-up visitReceive municipality-based follow-up visit including primary physician. |
| Usual care | No intervention | –Does not receive follow-up visit |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patient geography (The participant live in; Holbæk Kommune, Odsherred Kommune or Kalundborg Kommune.)
- Discharged from medical ward Holbæk Sygehus.
- Frailty (Rated by following criterion: dementia or a minimum of two of the following conditions; two or more hospitalisations within 12 month prior to follow up, los of physical function, treatment of two or more concurrent medical and/or surgical conditions, psychiatric disease, multi-pharmacy of more than 6 prescription medication, suspicious of congenital disturbances, substance abuse problem, disadvantaged social network, need for increasing home care following index hospitalization.)
Key exclusion criteria (2 listed)
- Not discharged to home (If the patient are not discharged to home.)
- No written consent (If the patient does not wish to participate / written consent are not signed.)
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 |
|---|---|---|
| Receive municipality-based follow-up visitAlso: Intervention groupSystematic electronic referral from hospital to municipality of high risk people at discharge from a medical ward. Contact from municipality service to primary physician and citizen, to arrange first home visit within 7 days with focus on: medication, rehabilitation plan and health care appointments, functional level and need for further health care initiatives. The visit is concluded by planning of further visits (up till tree) and division of responsibilities between primary physician and the municipality service. | Behavioural | Follow-up visit |
Primary outcome
Re-admission
Time frame: Within 30 days from discharge
The primary outcome is re-hospitalisation rate within 30 days from discharge. Data is obtained from the official register of danish patients (Landspatientregistret).
1 secondary outcome
Long-term hospitalization rate
Time frame: Within 180 days from discharge
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 21 Mar 2014.
- Derived from this study: PubMed 26059872Thygesen LC, Fokdal S, Gjorup T, Taylor RS, Zwisler AD; Prevention of Early Readmission Research Group. Can municipality-based post-discharge follow-up visits including a general practitioner reduce early readmission among the fragile elderly (65+ years old)? A randomized controlled trial. Scand J Prim Health Care. 2015 Jun;33(2):65-73. doi: 10.3109/02813432.2015.1041831. Epub 2015 Jun 10.
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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.
Thomas Gjørup principal investigator
Medicinsk Afdeling, Holbæk Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receive municipality-based follow-up visit in people with Frailty and Readmission, run by Holbaek Sygehus 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 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 21 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 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?
Re-admission (time frame: Within 30 days from discharge). 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 NCT02094040, 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 21 Mar 2014.