- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04777136
Home-visits From geRiatric tEam aFter hIp fracTure (REFIT)
The Effect of Home-visit Follow-up With a Multidisciplinary Geriatric Team in Old Patients With a Hip Fracture
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Capital Region
-
Herlev, Capital Region, Denmark, 2730
- Herlev and Gentofte Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- No ability to provide informed consent
- Patients, who dies within 48 hours of discharge
- Terminal patients
Nursing home residents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Geriatric home visit
Home-visit where a comprehensive geriatric assessment will be performed
|
Home-visit from the geriatric team, who will do a full geriatric assessment and targeted interventions
|
|
Active Comparator: Standard care
No follow-up.
|
Only follow-up on patients own initiative with contact to the general practitioner
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to contact to the general practitioner or hospital because of a fall
Time Frame: 90 days
|
Fall-related contact for treatment or assessment
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Contacts to a doctor
Time Frame: 90 days
|
Number of contacts to a doctor (either hospital or the general practitioner)
|
90 days
|
|
Contacts to a doctor
Time Frame: 30 days
|
Number of contacts to a doctor (either hospital or the general practitioner)
|
30 days
|
|
Falls
Time Frame: 30 days
|
number of falls
|
30 days
|
|
Falls
Time Frame: 90 days
|
number of falls
|
90 days
|
|
Preventable readmissions
Time Frame: 30 days
|
Number of readmission deemed preventable by two blinded assessors
|
30 days
|
|
Number of drugs
Time Frame: 30 days
|
Number of inappropriate drugs (Stop/Startt criteria)
|
30 days
|
|
Quality of life
Time Frame: 90 days
|
Assessment of Quality of life using questionnaire (EQ VAS 0-100)
|
90 days
|
|
Patient satisfaction and fear of falling
Time Frame: 30 days
|
Assessment patient satisfaction using questionnaire (Sat-UG-1)
|
30 days
|
|
Patient satisfaction and fear of faling
Time Frame: 90 days
|
Assessment patient satisfaction using questionnaire (Sat-UG-1)
|
90 days
|
|
All cause mortaliy
Time Frame: 30 days
|
Mortality
|
30 days
|
|
All cause mortaliy
Time Frame: 90 days
|
Mortality
|
90 days
|
|
Muscle strength
Time Frame: 90 days
|
Measured using "timed-up-and-go" test
|
90 days
|
|
Mobility
Time Frame: 90 days
|
Assessed using the "new mobility score" (0-10, high is good)
|
90 days
|
|
Mobility
Time Frame: 90 days
|
Assessed using the "Cumulated Ambulation Score" (0-6, high is good)
|
90 days
|
|
Weight
Time Frame: 90 days
|
Change in weight i kilograms from discharge "Cumulated Ambulation Score", and "new mobility score"
|
90 days
|
|
Independence
Time Frame: 90 days
|
Number of patients using walking aids
|
90 days
|
|
Independence
Time Frame: 90 days
|
Number of patients with a new placement at a nursing homes
|
90 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HgH_UGT_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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