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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06304584
Other study ID # P-2023-143
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2023
Est. completion date May 15, 2025

Study information

Verified date March 2024
Source University Hospital Bispebjerg and Frederiksberg
Contact Morten T Kristensen, Professor
Phone +4526152433
Email morten.tange.kristensen@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to learn about and monitor the cross-sectoral rehabilitation process in older high-risk patients treated for at fragility fracture of the hip. The main questions aim to answer: - how patients are doing up to one year after hip fracture surgery on different outcomes across the continuum of rehabilitation being offered - what expectations, experiences and satisfaction patients have for the overall rehabilitation process after a hip fracture Participants age 65 and above with home address in Frederiksberg municipality, living in own home, admitted and treated for at hip fracture at Department of Orthopedic Surgery, Bispebjerg Hospital, will be asked for participation.


Description:

In addition to primary and secondary outcome measures some of the patients will be asked to respond to a interviewer-based questionnaire, about their experiences of the rehabilitation offered during their hospital stay and at the temporary municipality-based 24-hour setting / or at home during the first couple of months. Furthermore, they will be interviewed about their expectations for rehabilitation in the municipality at time of discharge from the acute hospital.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date May 15, 2025
Est. primary completion date September 15, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: Undergone surgery for hip fracture and admitted to department M1, Bispebjerg-Frederiksberg Hospital Living in Frederiksberg municipality and being admitted from own home, or a 24 hour temporary setting in the municipality Exclusion Criteria: Living permanent in nursing home or is on the way to a permanent nursing home from a 24-hour setting.

Study Design


Locations

Country Name City State
Denmark Department of Physio- and Occupational Therapy and Othopedic Surgery, University Hospital Bispebjerg and Frederiksberg Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Bispebjerg and Frederiksberg Frederiksberg Municipality

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recovery of pre-fracture function Recovery of function related to the pre-fracture level (re-call last week before fracture) will be assessed with New mobility Score (score 0-9) pre-fracture, at start and end of rehabilitation in municipality, 3-4 month and 1 year post-fracture Recovery of pre-fracture function at 3-4 months post-fracture as primary outcome
Secondary Basic mobility Will be measured using Cumulated Ambulation Score (CAS). It describes the patients' independence in three activities (getting in and out of bed, sit-to-stand from a chair, and walking), with each activity assessed on a three-point ordinal scale from 0 to 2, resulting in a total CAS between 0 and 6 (6 is maximum score indicating the patient to be independent in basic mobility). Pre-fracture, at inclusion and discharge from hospital, at start and end of rehabilitation in municipality, 3-4 months and 1 year post-fracture
Secondary 30 second chair stand test (CST) CST test measures how many times a person can stand up from a chair in 30 seconds, without using their arms. At inclusion and discharge from hospital, at start and end of rehabilitation in municipality and 3-4 months post-fracture
Secondary Timed Up & Go test (TUG) TUG test measures the time in seconds it takes a person to stand up from a regular chair with back and armrests, walk 3 meters, turn around, go back to the chair and sit down again At start and end of rehabilitation in municipality and 3-4 months post-fracture
Secondary Hip related pain Will be assessed using the 5-point Verbal Rating Scale (VRS, no pain, slight pain, moderate pain, severe pain, and unbearable pain) during weight-bearing activities At inclusion and discharge from hospital, at start and end of rehabilitation in municipality, 3-4 months and 1 year post-fracture
Secondary Hand Grip Strength (HGS) HGS measures how much strength a person has in their dominant hand. If the dominant hand is injured (e.g. by paralysis or fracture), the test is carried out with the non-dominant hand. Although the measure of HGS assesses the function of one muscle group, it is regarded as an indicator of overall body strength. At inclusion at the hospital, at start and end of rehabilitation in municipality and 3-4 months post-fracture
Secondary Health questionnaire Will be assessed by the EQ-5D-5L questionnaire. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. At pre-fracture (recall) and 3-4 months and 1-year post-fracture
Secondary Physical activity (weekly) Will be assessed using a validated questionnaire from the Swedish National Board of Health and Welfare, providing a total score from 3 to 19. A score =11 corresponds to fulfillment of the Word Health Organization's recommendation for weekly physical activity At inclusion (recall of the last few weeks before present hospitalization) and 1-year post-fracture
Secondary Physical activity / upright time (time standing and walking) Will be measured using SENS Innovation Aps motion activity measurement system which is a waterproof activity sensor placed laterally on the opposite thigh of the fractured hip. From inclusion until 9 days post-discharge
Secondary Frailty Will be assessed using Clinical Frailty Scale (CFS) which is a clinical judgement-based frailty tool. The CFS evaluates specific domains including comorbidity, function., and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill). At pre-fracture (recall) and 1-year post-fracture
Secondary Fear of falling Will be assessed with Short-Falls Efficacy Scale, minimum 7 (no concern about falling) to maximum 28 (severe concern about falling). Assesses fear of falling conceptualized as concerns about falling in an 7 item questionnaire. At discharge and 3-4 months and 1-year post-fracture
Secondary Comorbidity Will be assessed using The American Society of Anesthesiologists (ASA) physical status classification system. The ASA score is a subjective assessment of a patient's overall health that is based on five classes. One means the patients is healthy and fit, and 5 is a moribund patient who is not expected to live 24 hour with or without surgery. At inclusion
Secondary Cognitive status Will be assessed using the Short Orientation-Memory Concentration (OMC). It consists of a 6-item patient reported questionnaire and is validated as a measure of cognitive impairment. The score ranges from 0-28 where 0 is equal to normal cognition and 28 is appraised as a severe impairment. At inclusion
Secondary Number of falls Place and cause At start and end of rehabilitation in municipality, 3-4 months and 1 year post-fracture
Secondary Residential status / discharge destination Residential status pre-fracture and discharge destination At discharge from hospital and 24-hour rehabilitation setting
Secondary Length of stay in acute hospital Number of days From surgery till discharge
Secondary Number of weekly exercise sessions with therapist in all settings The number of weekly exercise sessions with therapist at hospital, and in the municipality At discharge and end of rehabilitation in municipality
Secondary Number of rehab weeks In the municipality At end of rehabilitation in municipality
Secondary Type of training in Municipality Type of rehabilitation with a physiotherapist in Frederiksberg Municipality, at home or individual or team training in the centre, or a mixture of both At end of rehabilitation in the Municipality
Secondary Training after discharge from 24-hour setting If the patient has been on a 24-hour setting, is training then continued after discharge At discharge from 24-hour setting
Secondary Home care, nurse/other health assistance, times pr week Assistance with personal care, preparing dinner, grocery shopping, cleaning etc At pre-fracture, at start and end of rehabilitation in municipality and 3-4 months and 1-year post-fracture
Secondary Data 30 days post-discharge The patient record will be reviewed and it will be recorded if the patient has been readmitted or has died. 30 day post-discharge
Secondary Data 3 months post-discharge The patient record will be reviewed and it will be recorded if the patient has been readmitted or has died. 3 month post-discharge
Secondary Data 1 year post-discharge The patient record will be reviewed and it will be recorded if the patient has undergone reoperation or has died. 1 year post-discharge
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