Cross-sectoral Rehabilitation of Older High-risk Patients With Hip Fracture

Hip Fractures Clinical Trial

Official title:

Rehabilitation of Older High-risk Patients Treated for a Fragility Fracture of the Hip - a Cross-sectoral Study Between Bispebjerg-Frederiksberg Hospital and Frederiksberg Municipality - The HipFracture-Rehab1 Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06304584
• Other study ID #: P-2023-143
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Recovery of Function
• Rehabilitation

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