- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07478445
Home Rehabilitation After Hip Fracture (RECADO)
[Rehabilitación Domiciliaria Tras Fractura de Cadera] Home Rehabilitation After Hip Fracture
This study will examine whether a home-based rehabilitation program can help older adults recover after surgery for a hip fracture. The program is delivered by a specialized "Hospital-at-Home" unit, which provides hospital-level care in the patient's home.
Participants in this study are adults aged 65 years and older who have undergone hip fracture surgery at Hospital Universitari i Politècnic La Fe in Valencia, Spain. Instead of remaining in the hospital after surgery, participants will be admitted to the Hospital-at-Home program. A multidisciplinary medical team will provide comprehensive care at home, including medication management, wound care, and in-home physical therapy.
The primary goal of the study is to assess recovery of walking ability and mobility within the home. The study will also evaluate overall functional improvement, frailty, and survival. Participants will be assessed at the start of the program and again at 45 days and 180 days after surgery.
The information collected will help determine whether this type of home-based care is an effective option for supporting recovery and independence in older adults after a hip fracture.
Recruitment for the study began in February 2024 and is expected to continue for one year.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Valencia
-
Valencia, Valencia, Spain, 46026
- Hospital Universitari i Politècnic La Fe
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- - Patients aged 65 years or older undergoing surgery for traumatic hip fracture.
- Ability to actively collaborate in the physiotherapy program.
- Compliance with the UHD admission criteria (contact telephone number, identified caregiver, and residence within the geographical area of the Hospital Universitari i Politècnic La Fe).
Exclusion Criteria:
- - Patients residing outside the geographical area covered by the La Fe hospital UHD.
- Refusal to participate in the follow-up.
- Clinical instability or end-of-life situation (oncologic or non-oncologic).
- Cognitive impairment that prevents collaboration.
- Institutionalized patients.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Home rehabilitation of hip fracture
The cohort included patients with hip fracture who were referred from the hospital to home-based rehabilitation at discharge, managed by a multidisciplinary team that included physiotherapists.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Walking ability and home transfers
Time Frame: assessed at different time points (prior, admission to the UHD, and at 45 and 180 days).
|
Walking ability and home transfers, taken from the Barthel Index
|
assessed at different time points (prior, admission to the UHD, and at 45 and 180 days).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional improvement
Time Frame: prior, admission to the UHD, and at 45 and 180 days
|
measured by the change of the Barthel Index
|
prior, admission to the UHD, and at 45 and 180 days
|
|
Frailty was assessed with the Rockwood Index at the time of admission, at baseline
Time Frame: Baseline
|
The modified Clinical Frailty Scale (CFS) is a simple, 34-point clinical tool used by healthcare providers to quickly summarize a patient's overall level of fitness or frailty based on their mobility, energy, and function.
It helps predict outcomes and guide care decisions in older adults.
|
Baseline
|
|
Number of participants with all-cause readmission, delirium, wound infection, or bleeding
Time Frame: 15 days
|
Safety was assessed by monitoring the occurrence of all-cause readmissions, episodes of delirium, wound infection, or bleeding during the intervention period.
|
15 days
|
|
Mortality
Time Frame: 360 days
|
Number of deaths
|
360 days
|
|
Change in quality of life assessed by the EuroQoL-5D questionnaire
Time Frame: One year
|
Quality of life was assessed using the EuroQol-5D-3L (EQ-5D-3L), a standardized instrument measuring health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with three levels.
The descriptive system defines health states and does not itself yield a single score with fixed minimum and maximum values.
Health states can be converted into a utility index typically ranging from values below 0 (worse than death) to 1 (full health), where higher scores indicate better health.
Changes in quality of life will be assessed at 12 months
|
One year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ana Torrego, MD, PhD, Hospital at Home Unit - Hospital UiP La Fe Valencia Avda Fernando Abril Martorell 106 Torre B Planta 1 Valencia 26206 (SPAIN)
- Study Chair: Ana Soler, MD, PhD, Physical Medicine and Rehabilitation Service (SMFR); Hospital UiP La Fe Valencia Avda Fernando Abril Martorell 106
- Study Chair: Elisa Soriano, MD, PhD, Hospital at Home Unit Hospital UiP La Fe Valencia Avda Fernando Abril Martorell 106 Torre B Planta 1 Valencia 26206 (SPAIN)
- Principal Investigator: Marta Muñoz Domingo, Senior Technician / Research C, Universitat Politècnica de València (UPV) Centro de Investigación de Ingeniería Económica (CIEGS)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-0224-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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.
Clinical Trials on Hip Fractures (ICD-10 72.01-72.2)
-
JointResearchRecruitingHip Fractures (ICD-10 72.01-72.2)Netherlands
-
Region SkaneLund UniversityNot yet recruiting
-
South West Sydney Local Health DistrictNot yet recruitingRehabilitation Program | Hip Fractures (ICD-10 72.01-72.2)Australia
-
Medical University of GrazCompletedHip Fractures (ICD-10 72.01-72.2)Austria
-
Shanghai Geriatric Medical CenterRecruitingFemoral Neck Fractures | Hip Fractures (ICD-10 72.01-72.2) | Osteoarthritis, Knee and HipChina
-
Università degli Studi dell'InsubriaCompletedFemoral Fractures | Knee Arthroplasty | Ankle Fractures | Hip Arthroplasty | Pelvic Fractures | Hip Fractures (ICD-10 72.01-72.2)Italy
-
Bengt NellgårdCompletedDementia | Hip Fractures (ICD-10 72.01-72.2) | Alzheimer s DiseaseSweden
-
Royal College of Surgeons, IrelandHealth Service Executive, IrelandNot yet recruitingExercise Training | Resistance Training | Protein Supplementation | Strength Training | Hip Fractures (ICD-10 72.01-72.2) | Frailty at Older AdultsIreland
-
People's Hospital Affiliated to Hubei University...CompletedHip Fractures (ICD-10 72.01-72.2)China
-
Dr. Lutfi Kirdar Kartal Training and Research HospitalCompletedElderly Patients | Regional Anesthesia | Hip Fractures (ICD-10 72.01-72.2) | Postoperative Pain Management After Total Hip ArthroplastyTurkey (Türkiye)