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

Fear of Falling Intervention in Hip Fracture Geriatric Rehabilitation: a Cluster Randomised Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20252
Enrollment
165
Registered
2016-03-07
Start date
2016-03-09
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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

Sponsors

Leiden University Medical Center (LUMC) Department of Public Health and Primary Care (PHEG)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Main inclusion criteria: - Aged 65 years or older - Admitted to a geriatric rehabilitation (GR) unit for rehabilitation due to a hip fracture - Concerned to fall. This is measured by the one item fear of falling question (answering ‘positively’ in the category sometimes, often or very often)

Exclusion criteria

Exclusion criteria: - The patient has a condition interfering with learning ability, such as: 1. A diagnosis of dementia or score on the 'hetero-anamnesis list cognition' > 1, suggesting pre-morbid cognitive problems 2. A major psychiatric disease 3. Insufficient mastery of Dutch language - The patient has a limited life expectancy - The patient has a pathological hip fracture - Pre-fracture Barthel-index score < 15 (as a measure of ADL dependency)

Design outcomes

Primary

MeasureTime frame
1.Mean difference in The Tinetti Performance Oriented Mobility Assessment (POMA) score at discharge from GR (or at a maximum of 3 months of admittance to GR), compared between FIT-HIP intervention and usual care. The POMA is a measure of mobility function (gait and balance). 2. Mean difference in the Falls Efficacy Scale International (FES-I) score at discharge from GR (or at a maximum of 3 months of admittance to GR), compared between FIT-HIP intervention and usual care. The FES-I is a measure of fear of falling.

Secondary

MeasureTime frame
A. Effect evaluation: Mean differences for the following parameters at discharge from GR will be compared between FIT-HIP intervention and usual care: 1. Functional status (Barthel index, Functional Ambulation Categories). Time points: discharge. Follow up 1 and 2 (Barthel index). 2. Quality of life (EuroQOL five dimensions questionnaire). Time points: discharge, follow up 1 and 2. Also the following parameters will be compared between FIT-HIP intervention and usual care: 3. Number of falls (Fall calendar). Time points: discharge, follow up 1 and 2. 4. Mortality rate. 5. Discharge destination after rehabilitation. Time point: discharge. (“Home” = living address prior to the fracture. Any other discharge destination is labelled as “other”) 6. Participation after discharge from GR (Utrechtse Schaal voor Evaluatie van Revalidatie – Participatie). Time points: follow up 1 and 2. B. Process evaluation In accordance with the theory of Saunders and using a mixed-method approach (self-administered questionnaire and qualitative group interviews), fidelity; completeness; exposure; satisfaction; reach; recruitment and context will be evaluated as part of the process evaluation. C. Economic evaluation The economic evaluation consists of a cost analysis and a cost-utility analysis, both with a six-month time horizon after discharge from GR. Costs will be measured from a healthcare perspective. In the cost-utility analysis, the difference in healthcare costs between the strategies will be compared to the difference in Quality-Adjusted Life Years (QALYs, calculated using the Dutch EQ-5D tariff and the visual analogue scale for health). Estimated healthcare costs will include the costs of the FIT-HIP intervention (estimated from the study registration) and other healthcare utilization (estimated using quarterly questionnaires filled out by the patients). Other healthcare utilization will include general practitioners, other consultations, home care, informal care, hos

Contacts

Public ContactMaaike Scheffers-Barnhoorn

Postzone V0-P, (kamer V6-68), PO Box 9600, 2300 RC Leiden, The Netherlands

m.n.scheffers-barnhoorn@lumc.nl// fithip@lumc.nlTel: 071-5268444

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)