'Rehabilitation for Life'
Primary Purpose
Hip Fractures
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
'Rehabilitation for Life'
Usual care and rehabilitation
Sponsored by
About this trial
This is an interventional health services research trial for Hip Fractures focused on measuring Rehabilitation, cross-sectorial cooperation, older
Eligibility Criteria
Inclusion Criteria:
- Patients with a hip fracture
- Patients of 65 years of age or older
- Patients admitted to an orthogeriatric ward
- Patient who are citizens in one og three municipalities
Exclusion Criteria:
- Patients discharged for permanent residence in nursing homes
- Patients who cannot participate in a conversation
- Terminal registered patients.
Sites / Locations
- Inge BruunRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
'Rehabilitation for Life'
Usual care and rehabilitation
Arm Description
Vital sign measurement and rehabilitation
Usual care and rehabilitation provided in primary and secondary sectors
Outcomes
Primary Outcome Measures
Timed up and go
Measures functional mobility, as the time in seconds it takes a person to rise from a chair with arms, walk 3 m and return to the chair. A higher scores mean a worse outcome
Secondary Outcome Measures
Cumulated Ambulation Score (CAS)
Measures basic mobility. The score 0-6. Higher scores mean a better outcome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04424186
Brief Title
'Rehabilitation for Life'
Official Title
Effect of Measuring Vital Signs and Coherent Rehabilitation in Primary and Secondary Sectors in Older Adults After Hip Fracture Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kolding Sygehus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Despite implementing hospital quality programs after hip fracture surgery older adults often experience a decline in the level of physical function, reduced quality of life; and the mortality and readmission rates are high.
Early mobilization is important in order to prevent loss of muscle mass; however to prevent morbidity an early start of strength training is also necessary. Furthermore, the risk of complications, morbidity, and mortality are associated with insufficient management of pain.
The project aims to examine the effect of measuring vital signs and consistent rehabilitation in the primary and secondary sectors in older adults after hip fracture surgery.
Method/ design:
The study is a cluster-randomized stepped wedge study. Participants will be recruited among patients admitted to an orthogeriatric ward who are 65 years of age or older and citizens in one of three municipalities. Participants are also the health professionals in the orthogeriatric ward and the three municipalities.
The three municipalities form five clusters, which are randomized, and every three-month one cluster cross from control to intervention.
The study compares usual practice (control) to an intervention named 'Rehabilitation of Life'. An intervention best described as an empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation and combined with convenient access for collaboration among professionals.
Primary outcome: Timed Up and Go (TUG) measured 2 months after the time of operation.
The investigators hypothesize that 'Rehabilitation of Life' for older adults with a hip fracture will result in a significant reduced TUG-score in comparison to a practice not offering 'Rehabilitation of Life'
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Rehabilitation, cross-sectorial cooperation, older
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A cluster-randomized stepped wedge study. A design that is initiated with a period without interventions followed by a form of cross-over, in which each cluster systematic cross from control to intervention.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
'Rehabilitation for Life'
Arm Type
Experimental
Arm Description
Vital sign measurement and rehabilitation
Arm Title
Usual care and rehabilitation
Arm Type
Active Comparator
Arm Description
Usual care and rehabilitation provided in primary and secondary sectors
Intervention Type
Other
Intervention Name(s)
'Rehabilitation for Life'
Intervention Description
An empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation combined with convenient access for collaboration among professionals.
Intervention Type
Other
Intervention Name(s)
Usual care and rehabilitation
Intervention Description
The care and rehabilitation usual provided to patients after hip fracture surgery
Primary Outcome Measure Information:
Title
Timed up and go
Description
Measures functional mobility, as the time in seconds it takes a person to rise from a chair with arms, walk 3 m and return to the chair. A higher scores mean a worse outcome
Time Frame
Two months after the time of operation
Secondary Outcome Measure Information:
Title
Cumulated Ambulation Score (CAS)
Description
Measures basic mobility. The score 0-6. Higher scores mean a better outcome
Time Frame
One months after the time of operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a hip fracture
Patients of 65 years of age or older
Patients admitted to an orthogeriatric ward
Patient who are citizens in one og three municipalities
Exclusion Criteria:
Patients discharged for permanent residence in nursing homes
Patients who cannot participate in a conversation
Terminal registered patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Inge Bruun, post doc
Phone
+45 7636 2886
Email
Inge.Hansen.Bruun@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inge Bruun, post doc
Organizational Affiliation
The Region of Southern Denmark and University of Southern Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Inge Bruun
City
Kolding
State/Province
Southern Denmark
ZIP/Postal Code
6000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inge Bruun
Phone
76362886
Email
Inge.Hansen.Bruun@rsyd.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35526010
Citation
Ipsen JA, Pedersen LT, Viberg B, Norgaard B, Suetta C, Bruun IH. Rehabilitation for life: the effect on physical function of rehabilitation and care in older adults after hip fracture-study protocol for a cluster-randomised stepped-wedge trial. Trials. 2022 May 7;23(1):375. doi: 10.1186/s13063-022-06321-w.
Results Reference
derived
Learn more about this trial
'Rehabilitation for Life'
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