Frail Elderly SyndromeNCT03796923
Models of Care in the Transition From the Secondary to the Primary Sector Among the Frailest Elderly
A study testing Early follow-up visit after discharge, Comprehensive geriatric assessment (CGA) and Continued geriatric care in people with Frail Elderly Syndrome and Transitional Care, run by University of Aarhus at 1 site in Denmark.
Trial summary
In most Western countries the elderly population increases rapidly. In Denmark, the population of elderly aged 75 years or older may amount to nearly 15 % of the entire population in 2050 compared to 9 % today (2017). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Transitional Care, Frailty
- What is being tested?
- Early follow-up visit after discharge, Comprehensive geriatric assessment (CGA) and Continued geriatric care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,340 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2018to 16 Nov 2020
- 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
- Aged 75 years or older
- Living within the municipality of Aarhus (except for the control group, see below)
- MPI-score = 2 (moderate frailty) or MPI score = 3 (severe frailty)
Who cannot join
- Included in any other kind of follow-up schemes
- Declared terminally ill or undergoing palliative care at admission
- Admitted from one specific temporary nursing home with geriatric medical assistance
- Discharge or transfer to another department, including hospice
- MPI-score = 1 (low frailty)
- Discharged to one specific temporary nursing home with geriatric medical assistance
- The patient does not want a visit after discharge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Models of Care in the Transition From the Secondary to the Primary Sector Among the Frailest Elderly +75; a Randomized Controlled Trial
In most Western countries the elderly population increases rapidly. In Denmark, the population of elderly aged 75 years or older may amount to nearly 15 % of the entire population in 2050 compared to 9 % today (2017). A large part of the elderly population is at high risk of hospitalization including more admissions and increased morbidity and mortality. The number of hospital beds is declining persistently, calling for shorter lengths of stay (LOS). Increasingly complex treatments now take place outside hospital. Presently, many Danish regional hospitals establish geriatric wards and other geriatric in-hospital and outpatient services to overcome these challenges. The aim of the present PhD-study is to investigate the effects of different models of transitional care among the frailest elderly patients.
Read the detailed description
Design Population: The frailest acutely admitted geriatric patients aged +75. Intervention: Early follow-up visits after discharge. Comparison: Usual care follow-up. Outcomes: The primary outcome is readmission within 30 days after discharge. Secondary outcomes are: mortality 30 days after discharge and 90 days after admission, length of stay (LOS), direct discharge from the Emergency Department, time at home before readmission, duration of readmission and physical functional status 30 days after discharge.
Methods The first study is conducted as a randomized controlled trial (RCT) using two different degrees of intervention. The second study is a cohort study of an unexposed control group. The third study is sub-group analyses of the RCT data according to frailty status and type of dwelling.
A focus group comprised of included patients and relatives will be set to identify additional patient related outcome measures (PROMs) and to participate in an advisory group throughout the remaining project.
- Conditions
- Frail Elderly Syndrome, Transitional Care, Frailty, Readmission, Aging, Elderly
- Being tested
- Early follow-up visit after discharge, Comprehensive geriatric assessment (CGA), Continued geriatric care, Possible follow-up visit from GP
- Keywords
- Elderly, Hospital at home, Readmission, Transitional care, Frailty, Patient Related Outcome Measures
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early follow-up visit after dischargeOther
Early follow-up visit and different degrees of specialized care after discharge
Comprehensive geriatric assessment (CGA)Other
Comprehensive geriatric assessment (CGA) during admission
Continued geriatric careOther
Continued specialized geriatric care after discharge
Possible follow-up visit from GPOther
Usual care: follow up visit from GP within one week after discharge
| Study group | Role | What they receive |
|---|---|---|
| Intervention I | Active comparator | Intervention (I): early follow-up visit from the community nurse within 24 hours after discharge Receives: Other: Early follow-up visit after discharge; Other: Comprehensive geriatric assessment (CGA) |
| Intervention II | Experimental | Intervention (II): early follow-up by the geriatric team within 24 hours after discharge Receives: Other: Early follow-up visit after discharge; Other: Comprehensive geriatric assessment (CGA); Other: Continued geriatric care |
| Control | Other | Usual care: individualized follow-up performed by the GP and municipality services Receives: Other: Possible follow-up visit from GP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission
Readmission within 30 days after discharge
Measured: 30 days
Secondary outcomes (2)
Mortality
Mortality within 90 days after admission and 30 days after discharge
Measured: 90 days after admission and 30 days after primary discharge
Length of stay (LOS)
Length of stay during primary admission and total length of stay including following readmissions
Measured: 30 days after primary discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Jan 2018
- Primary completion16 Sep 2020
- Study completion16 Nov 2020
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 University of AarhusThe 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
- None (open label)
- Enrolment
- 3,340 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Else Marie S Damsgaard, Prof., DMSci, Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796923
- Sponsor's protocol ID
- MOCATRANFRAELRCT
- Status last verified
- Apr 2021
- First submitted
- 2 Jan 2019
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hansen TK, Pedersen LH, Shahla S, Damsgaard EM, Bruun JM, Gregersen M. Effects of a new early municipality-based versus a geriatric team-based transitional care intervention on readmission and mortality among frail older patients - a randomised controlled trial. Arch Gerontol Geriatr. 2021 Nov-Dec;97:104511. doi: 10.1016/j.archger.2021.104511. Epub 2021 Aug 26.
PubMed 34479071
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Models of Care in the Transition From the Secondary to the Primary Sector Among the Frailest Elderly +75; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03796923
- Acronym / sponsor ID
- MOCATRANFRAELRCT
- Conditions
- Frail Elderly Syndrome, Transitional Care, Frailty, Readmission, Aging, Elderly
- Keywords
- Elderly, Hospital at home, Readmission, Transitional care, Frailty, Patient Related Outcome Measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,340 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 8 Jan 2019 (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.
In most Western countries the elderly population increases rapidly. In Denmark, the population of elderly aged 75 years or older may amount to nearly 15 % of the entire population in 2050 compared to 9 % today (2017). A large part of the elderly population is at high risk of hospitalization including more admissions and increased morbidity and mortality. The number of hospital beds is declining persistently, calling for shorter lengths of stay (LOS). Increasingly complex treatments now take place outside hospital. Presently, many Danish regional hospitals establish geriatric wards and other geriatric in-hospital and outpatient services to overcome these challenges. The aim of the present PhD-study is to investigate the effects of different models of transitional care among the frailest elderly patients.
Detailed description
Design Population: The frailest acutely admitted geriatric patients aged +75. Intervention: Early follow-up visits after discharge. Comparison: Usual care follow-up. Outcomes: The primary outcome is readmission within 30 days after discharge. Secondary outcomes are: mortality 30 days after discharge and 90 days after admission, length of stay (LOS), direct discharge from the Emergency Department, time at home before readmission, duration of readmission and physical functional status 30 days after discharge.
Methods The first study is conducted as a randomized controlled trial (RCT) using two different degrees of intervention. The second study is a cohort study of an unexposed control group. The third study is sub-group analyses of the RCT data according to frailty status and type of dwelling.
A focus group comprised of included patients and relatives will be set to identify additional patient related outcome measures (PROMs) and to participate in an advisory group throughout the remaining project.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention I | Active comparator | Other: Early follow-up visit after discharge, Other: Comprehensive geriatric assessment (CGA)Intervention (I): early follow-up visit from the community nurse within 24 hours after discharge |
| Intervention II | Experimental | Other: Early follow-up visit after discharge, Other: Comprehensive geriatric assessment (CGA), Other: Continued geriatric careIntervention (II): early follow-up by the geriatric team within 24 hours after discharge |
| Control | Other | Other: Possible follow-up visit from GPUsual care: individualized follow-up performed by the GP and municipality services |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 75 years or older
- Living within the municipality of Aarhus (except for the control group, see below)
- MPI-score = 2 (moderate frailty) or MPI score = 3 (severe frailty)
Key exclusion criteria (7 listed)
- Included in any other kind of follow-up schemes
- Declared terminally ill or undergoing palliative care at admission
- Admitted from one specific temporary nursing home with geriatric medical assistance
- Discharge or transfer to another department, including hospice
- MPI-score = 1 (low frailty)
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 |
|---|---|---|
| Early follow-up visit after dischargeEarly follow-up visit and different degrees of specialized care after discharge | Other | Intervention I, Intervention II |
| Comprehensive geriatric assessment (CGA)Comprehensive geriatric assessment (CGA) during admission | Other | Intervention I, Intervention II |
| Continued geriatric careContinued specialized geriatric care after discharge | Other | Intervention II |
| Possible follow-up visit from GPUsual care: follow up visit from GP within one week after discharge | Other | Control |
Primary outcome
Readmission
Time frame: 30 days
Readmission within 30 days after discharge
2 secondary outcomes
Mortality
Time frame: 90 days after admission and 30 days after primary discharge
Length of stay (LOS)
Time frame: 30 days after primary 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 30 Apr 2021.
- Derived from this study: PubMed 34479071Hansen TK, Pedersen LH, Shahla S, Damsgaard EM, Bruun JM, Gregersen M. Effects of a new early municipality-based versus a geriatric team-based transitional care intervention on readmission and mortality among frail older patients - a randomised controlled trial. Arch Gerontol Geriatr. 2021 Nov-Dec;97:104511. doi: 10.1016/j.archger.2021.104511. Epub 2021 Aug 26.
- Individual participant dataSharing planned: Undecided
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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.
Else Marie S Damsgaard, Prof., DMSci study chair
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early follow-up visit after discharge, Comprehensive geriatric assessment (CGA) and Continued geriatric care in people with Frail Elderly Syndrome and Transitional Care, run by University of Aarhus 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 7 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 30 Apr 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 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?
Readmission (time frame: 30 days). 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 NCT03796923, 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 30 Apr 2021.