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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04777136
Other study ID # HgH_UGT_01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date February 28, 2023

Study information

Verified date May 2022
Source Herlev Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 satisfaction and quality of life.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date February 28, 2023
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 70 Years to 120 Years
Eligibility 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 Design


Intervention

Other:
Home visit and comprehensive geriatric assessment
Home-visit from the geriatric team, who will do a full geriatric assessment and targeted interventions
Control group, no designated follow up
Only follow-up on patients own initiative with contact to the general practitioner

Locations

Country Name City State
Denmark Herlev and Gentofte hospital Herlev Capital Region

Sponsors (1)

Lead Sponsor Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to contact to the general practitioner or hospital because of a fall Fall-related contact for treatment or assessment 90 days
Secondary Contacts to a doctor Number of contacts to a doctor (either hospital or the general practitioner) 90 days
Secondary Contacts to a doctor Number of contacts to a doctor (either hospital or the general practitioner) 30 days
Secondary Falls number of falls 30 days
Secondary Falls number of falls 90 days
Secondary Preventable readmissions Number of readmission deemed preventable by two blinded assessors 30 days
Secondary Number of drugs Number of inappropriate drugs (Stop/Startt criteria) 30 days
Secondary Quality of life Assessment of Quality of life using questionnaire (EQ VAS 0-100) 90 days
Secondary Patient satisfaction and fear of falling Assessment patient satisfaction using questionnaire (Sat-UG-1) 30 days
Secondary Patient satisfaction and fear of faling Assessment patient satisfaction using questionnaire (Sat-UG-1) 90 days
Secondary All cause mortaliy Mortality 30 days
Secondary All cause mortaliy Mortality 90 days
Secondary Muscle strength Measured using "timed-up-and-go" test 90 days
Secondary Mobility Assessed using the "new mobility score" (0-10, high is good) 90 days
Secondary Mobility Assessed using the "Cumulated Ambulation Score" (0-6, high is good) 90 days
Secondary Weight Change in weight i kilograms from discharge "Cumulated Ambulation Score", and "new mobility score" 90 days
Secondary Independence Number of patients using walking aids 90 days
Secondary Independence Number of patients with a new placement at a nursing homes 90 days
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