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Clinical Trials/NCT04424186
NCT04424186CompletedNot Applicable

Effect of Measuring Vital Signs and Coherent Rehabilitation in Primary and Secondary Sectors in Older Adults After Hip Fracture Surgery

Kolding Sygehus2 sites in 1 country339 target enrollmentStarted: September 22, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
339
Locations
2
Primary Endpoint
Timed up and go

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Timed up and go

Time Frame: Two months after the time of operation

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

Cumulated Ambulation Score (CAS)

Time Frame: One months after the time of operation

Measures basic mobility. The score 0-6. Higher scores mean a better outcome

Secondary Outcomes

  • Timed up and go(Three and six months after the time of operation)
  • Barthel-20(2, 3, 6 and 12 months after the time of surgery)

Investigators

Sponsor
Kolding Sygehus
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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