Geriatric AssessmentREFITNCT04777136
Home-visits From geRiatric tEam aFter hIp fracTure
A study testing Home visit and comprehensive geriatric assessment in people with Geriatric Assessment and Hip Fractures, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The primary objective is to examine the effect of multidisciplinary geriatric team home-visits as follow-up after a hip fracture in old patients. The hypothesis is that home-visits will reduce the number of falls, readmissions, prevent functional decline, optimize that medical treatment, and a higher degree of… Read more about this study
- Who is it for?
- Ages 70 to 120 years
- Conditions the study is for
- Geriatric Assessment, Hip Fractures, Frailty
- What is being tested?
- Home visit and comprehensive geriatric assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 28 Feb 2023
- 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 70 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age of 70 years or older
- Hip fracture
- Ability to provide informed consent
- Residence in one of three following municipalities: Gladsaxe, Rudersdal or Lyngby-Taarbæk
Who cannot join
- No ability to provide informed consent
- Patients, who dies within 48 hours of discharge
- Terminal patients
- Nursing home residents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Home-visit Follow-up With a Multidisciplinary Geriatric Team in Old Patients With a Hip Fracture
The primary objective is to examine the effect of multidisciplinary geriatric team home-visits as follow-up after a hip fracture in old patients. The hypothesis is that home-visits will reduce the number of falls, readmissions, prevent functional decline, optimize that medical treatment, and a higher degree of satisfaction and quality of life.
Read the detailed description
Among older individuals, falling is a strong predictor of frailty, morbidity, and mortality and may cause a fracture. Many older patients experience recurrent falls, further functional decline, and readmission within the first three months. Hence, fall-related visits to the hospital represent a "red flag" but are also an opportunity for targeted intervention and prevention of future falls. However, many older patients are only treated for fall-related injuries and discharged without fall risk assessment or evaluation, hence there is a need for follow-up with targeted fall assessment and intervention to prevent further falls.
Thus, the present project aims to examine the effect of home-visit follow-up of older frail patients discharged from the orthopedic ward with a hip fracture. Furthermore, we will explore the effect of a cross-sectorial collaboration between hospital and municipality in the patients' homes to prevent falls, readmissions, medicine-associated adverse effects, and physical deconditioning in old frail patients.
The present study is a interventional trial. The intervention will consist of a home visit within ten weekdays of the discharge, where a comprehensive geriatric assessment (CGA) will be performed. The team performing the CGA consist of a Geriatrician and an experienced geriatric nurse. CGA is an overall assessment of the patient taking account of; the presence and severity of comorbidity, the nutritional state, cognitive and functional status, review of current medications, and social measures. The purpose is to stabilize and optimize current as well as chronic conditions, and reduce the probability of adverse events and falls, and to secure interventions or changes persist through the transition from the secondary to the primary health care system. The assessment may lead to several interventions, including; medicine review (new medicine, change in current or discontinuation), initiation of a nutritional effort or contact to a dietitian, referral to other health care services (outpatient clinics, hospitals, or general practitioner), referral to physiotherapy and/or occupational therapy or optimization of home care.
Patients randomized to the control group will receive standard care, where the subsequent need for medical service or increased home care will require contact with the general practitioner or the municipality, at the patient's initiative.
- Conditions
- Geriatric Assessment, Hip Fractures, Frailty, Old Age; Atrophy
- Being tested
- Home visit and comprehensive geriatric assessment, Control group, no designated follow up
- Keywords
- Geriatric assesment, hip fracture, Home-visit, Old patients
- Medical subject headings
- Hip Fractures, Frailty, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visit and comprehensive geriatric assessmentOther
Home-visit from the geriatric team, who will do a full geriatric assessment and targeted interventions
Control group, no designated follow upOther
Only follow-up on patients own initiative with contact to the general practitioner
| Study group | Role | What they receive |
|---|---|---|
| Geriatric home visit | Experimental | Home-visit where a comprehensive geriatric assessment will be performed Receives: Other: Home visit and comprehensive geriatric assessment |
| Standard care | Active comparator | No follow-up. Receives: Other: Control group, no designated follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to contact to the general practitioner or hospital because of a fall
Fall-related contact for treatment or assessment
Measured: 90 days
Secondary outcomes (17)
Contacts to a doctor
Number of contacts to a doctor (either hospital or the general practitioner)
Measured: 90 days
Contacts to a doctor
Number of contacts to a doctor (either hospital or the general practitioner)
Measured: 30 days
Falls
number of falls
Measured: 30 days
Falls
number of falls
Measured: 90 days
Preventable readmissions
Number of readmission deemed preventable by two blinded assessors
Measured: 30 days
Number of drugs
Number of inappropriate drugs (Stop/Startt criteria)
Measured: 30 days
Quality of life
Assessment of Quality of life using questionnaire (EQ VAS 0-100)
Measured: 90 days
Patient satisfaction and fear of falling
Assessment patient satisfaction using questionnaire (Sat-UG-1)
Measured: 30 days
Patient satisfaction and fear of faling
Assessment patient satisfaction using questionnaire (Sat-UG-1)
Measured: 90 days
All cause mortaliy
Mortality
Measured: 30 days
All cause mortaliy
Mortality
Measured: 90 days
Muscle strength
Measured using "timed-up-and-go" test
Measured: 90 days
Mobility
Assessed using the "new mobility score" (0-10, high is good)
Measured: 90 days
Mobility
Assessed using the "Cumulated Ambulation Score" (0-6, high is good)
Measured: 90 days
Weight
Change in weight i kilograms from discharge "Cumulated Ambulation Score", and "new mobility score"
Measured: 90 days
Independence
Number of patients using walking aids
Measured: 90 days
Independence
Number of patients with a new placement at a nursing homes
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Apr 2022
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric AssessmentStudies 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
- Model description
- Home visit from the geriatric team
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Schultz, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777136
- Sponsor's protocol ID
- HgH_UGT_01
- Acronym
- REFIT
- Status last verified
- May 2022
- First submitted
- 16 Feb 2021
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Home-visit Follow-up With a Multidisciplinary Geriatric Team in Old Patients With a Hip Fracture
- ClinicalTrials.gov ID
- NCT04777136
- Acronym / sponsor ID
- REFIT / HgH_UGT_01
- Conditions
- Geriatric Assessment, Hip Fractures, Frailty, Old Age; Atrophy
- Keywords
- Geriatric assesment, hip fracture, Home-visit, Old patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 2 Mar 2021 (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.
The primary objective is to examine the effect of multidisciplinary geriatric team home-visits as follow-up after a hip fracture in old patients. The hypothesis is that home-visits will reduce the number of falls, readmissions, prevent functional decline, optimize that medical treatment, and a higher degree of satisfaction and quality of life.
Detailed description
Among older individuals, falling is a strong predictor of frailty, morbidity, and mortality and may cause a fracture. Many older patients experience recurrent falls, further functional decline, and readmission within the first three months. Hence, fall-related visits to the hospital represent a "red flag" but are also an opportunity for targeted intervention and prevention of future falls. However, many older patients are only treated for fall-related injuries and discharged without fall risk assessment or evaluation, hence there is a need for follow-up with targeted fall assessment and intervention to prevent further falls.
Thus, the present project aims to examine the effect of home-visit follow-up of older frail patients discharged from the orthopedic ward with a hip fracture. Furthermore, we will explore the effect of a cross-sectorial collaboration between hospital and municipality in the patients' homes to prevent falls, readmissions, medicine-associated adverse effects, and physical deconditioning in old frail patients.
The present study is a interventional trial. The intervention will consist of a home visit within ten weekdays of the discharge, where a comprehensive geriatric assessment (CGA) will be performed. The team performing the CGA consist of a Geriatrician and an experienced geriatric nurse. CGA is an overall assessment of the patient taking account of; the presence and severity of comorbidity, the nutritional state, cognitive and functional status, review of current medications, and social measures. The purpose is to stabilize and optimize current as well as chronic conditions, and reduce the probability of adverse events and falls, and to secure interventions or changes persist through the transition from the secondary to the primary health care system. The assessment may lead to several interventions, including; medicine review (new medicine, change in current or discontinuation), initiation of a nutritional effort or contact to a dietitian, referral to other health care services (outpatient clinics, hospitals, or general practitioner), referral to physiotherapy and/or occupational therapy or optimization of home care.
Patients randomized to the control group will receive standard care, where the subsequent need for medical service or increased home care will require contact with the general practitioner or the municipality, at the patient's initiative.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Home visit from the geriatric team
| Arm | Type | Receives |
|---|---|---|
| Geriatric home visit | Experimental | Other: Home visit and comprehensive geriatric assessmentHome-visit where a comprehensive geriatric assessment will be performed |
| Standard care | Active comparator | Other: Control group, no designated follow upNo follow-up. |
Who may qualify
- Ages
- 70 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age of 70 years or older
- Hip fracture
- Ability to provide informed consent
- Residence in one of three following municipalities: Gladsaxe, Rudersdal or Lyngby-Taarbæk
Key exclusion criteria (4 listed)
- No ability to provide informed consent
- Patients, who dies within 48 hours of discharge
- Terminal patients
- Nursing home residents
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 |
|---|---|---|
| Home visit and comprehensive geriatric assessmentHome-visit from the geriatric team, who will do a full geriatric assessment and targeted interventions | Other | Geriatric home visit |
| Control group, no designated follow upOnly follow-up on patients own initiative with contact to the general practitioner | Other | Standard care |
Primary outcome
Time to contact to the general practitioner or hospital because of a fall
Time frame: 90 days
Fall-related contact for treatment or assessment
17 secondary outcomes
Contacts to a doctor
Time frame: 90 days
Contacts to a doctor
Time frame: 30 days
Falls
Time frame: 30 days
Falls
Time frame: 90 days
Preventable readmissions
Time frame: 30 days
Number of drugs
Time frame: 30 days
Quality of life
Time frame: 90 days
Patient satisfaction and fear of falling
Time frame: 30 days
Patient satisfaction and fear of faling
Time frame: 90 days
All cause mortaliy
Time frame: 30 days
All cause mortaliy
Time frame: 90 days
Muscle strength
Time frame: 90 days
Mobility
Time frame: 90 days
Mobility
Time frame: 90 days
Weight
Time frame: 90 days
Independence
Time frame: 90 days
Independence
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- 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 Home visit and comprehensive geriatric assessment in people with Geriatric Assessment and Hip Fractures, run by Herlev 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 4 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: status not confirmed, as of the sponsor's last update on 20 May 2022. 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?
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?
Time to contact to the general practitioner or hospital because of a fall (time frame: 90 days). 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 20 May 2022.