Clinical trial NCT04424186: '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
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Keywords: Rehabilitation
cross-sectorial cooperation
older
Lead sponsor: Kolding Sygehus
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 339
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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 six municipalities. Participants are also the health professionals in the orthogeriatric ward and the six municipalities.

The six municipalities form six 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 outcomes: 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'.

And as the study is organised across two sectors, the Cumulated Ambulation Score (CAS) makes a second primary outcome. It is hypothesised that patients in the intervention group will achieve a significantly reduced TUG score compared to usual care.


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.

Primary outcomes:
measure: Timed up and go
timeFrame: Two months after the time of operation
measure: Cumulated Ambulation Score (CAS)
timeFrame: One months after the time of operation
Secondary outcomes:
measure: Timed up and go
timeFrame: Three and six months after the time of operation
measure: Barthel-20
timeFrame: 2, 3, 6 and 12 months after the time of surgery
Other outcomes:
measure: Eq-5D
timeFrame: 2, 3, 6 and 12 months after the time of surgery
measure: Mortality 30 days and 1 year.
timeFrame: Mortality measured after 30 days and one year
measure: Readmission
timeFrame: Readmission measured 30 days after discharge
Locations:
city: Kolding
country: Denmark
facility: Inge Bruun
state: Southern Denmark
Study officials:
affiliation: The Region of Southern Denmark and University of Southern Denmark
name: Inge Bruun, post doc
role: STUDY_CHAIR
References:
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.