A randomised controlled trial to improve outcomes of hip fracture patients with fear of falling in geriatric rehabilitation

Rationale: Annually in the Netherlands 15.000 elderly patients (55 years or older) are admitted to hospital because of a hip fracture. Of these patients, approximately 3500-5000 are discharged to a skilled nursing home to take part in an inpatient geriatric rehabilitation program (GR). The functional prognosis after a hip fracture is poor with a 1 year mortality rate of 20-30%. A great deal of the patients experience permanent functional disability, with only 40% recovering to their pre-fracture functional state. Factors that influence functional outcome are pre-fracture functional state (activities in daily living and walking function), age, sex, cognitive function, depression and fear of falling. Fear of falling possibly has a greater effect on functional outcome than pain or depression. Currently there are no programs known available aimed at reducing fear of falling among hip fracture patients admitted to geriatric rehabilitation units.



Objective: To determine the effects, feasibility and costs of a multi-component cognitive behavioural intervention for reducing fear of falling and associated activity restriction in hip fracture patients admitted for geriatric rehabilitation.



Study design: Cluster randomised controlled trial, with blinding of patients and outcome assessors.



Study population: Hip fracture patients aged 65 years or older, admitted to a geriatric rehabilitation unit for rehabilitation.
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Main exclusion criteria: factors interfering with learnability (diagnosis of dementia or score on the 'hetero-anamnesis list cognition' > 1, suggesting pre-morbid cognitive problems, major psychiatric disease, insufficient mastery of Dutch language), limited life expectancy, patients with a pathological hip fracture and patients with a pre-fracture Barthelindex score < 15.



Intervention: The control group receives care as usual, as embedded in the care pathway geriatric rehabilitation for hip fracture patients. The intervention group receives the FIT-HIP intervention integrated in the usual care. The FIT-HIP intervention consists of various elements of cognitive behaviour therapy (guided exposure, psycho-education, cognitive restructuring and relapse prevention). This will be combined with exercise training in the physiotherapy sessions.



Main study parameters/endpoints:
Effect evaluation: Reduction in the fear of falling, measured with the Falls Efficacy Scale International (FES-I). Improvement in mobility measured by the Tinetti Performance Oriented Mobility Assessment (POMA).
Process evaluation: Within the framework of the process evaluation, fidelity; completeness; exposure; satisfaction; reach; recruitment and context will be evaluated by quantitative and qualitative analysis.


Economic evaluation: Cost analysis (from a healthcare perspective) and cost-utility analysis (comparing healthcare costs to Quality-Adjusted Life Years).

Treatment of fear of falling in hip fracture patients in GR, using the FIT-HIP intervention, will lead to reduction of fear of falling and therefore to an improvement of mobility function (gait and balance), in comparison to patients with fear of falling who do not receive this treatment.

- Baseline measurements: first week of admission to GR

- Discharge measurements: last week of admission to GR

- Follow up 1: 3 months after discharge from GR

- Follow up 2: 6 months after discharge from GR

The control group receives care as usual, as embedded in the care pathway geriatric rehabilitation for hip fracture patients. The intervention group receives the FIT-HIP intervention integrated in the usual care. The FIT-HIP intervention consists of various elements of cognitive behaviour therapy (guided exposure, psycho-education, cognitive restructuring, relapse prevention). This will be combined with exercise training in the physiotherapy sessions.