Cognitive Intervention and Rehabilitation Outcomes in Hip Fracture Patients

Study Overview
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Brief Summary
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The objective of the present study is to assess whether specific cognitive intervention will influence rehabilitation outcomes of post-acute hip fracture patients.

Detailed Description
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Hip fracture often occurs in frail older people and is a major concern for the health care systems because it is associated with an up to 36% excess mortality within 1 year. Hip fracture also represents a risk factor for further falls and fractures, functional decline and institutionalization, with <40% of hip fractured patients regaining their pre-injury level of ambulation. One of the most challenging tasks of today's post-acute geriatric rehabilitation wards is improving the functional abilities of fragile hip-fractured patients and discharging most of them to their homes. Yet, the rising incidence of hip fractures in the elderly has created an overwhelming workload on those departments and has significantly increased the burden on healthcare resources. Previous studies have found that cognitive decline is an important negative predictor in rehabilitation. Several studies have shown that cognitive interventions can improve functional abilities of older people. Yet, these studies were conducted in community dwelling older people. Our study will assess this issue amongst post-acute rehabilitation hip fracture patients. Our hypotyhesis is that those patients recieving specific cognitive intervention will show significantly better rehabilitation outcomes and cognitive function. The objective of the present study is to assess whether specific cognitive intervention will influence rehabilitation outcomes of post-acute hip fracture patients. This is a randomized double blinded study. We will compare two groups: one will recieve specific cognitive intervention and a control group will recieve conventional occupational therapy treatment. Both groups will recieve the same amount of interventions.The interventions will include all together 12 sessions, each being 45 minutes, for a total of 3 weeks. The intervention will include: 4 treatments in the area of memory and attention, 4 treatments in the area of problem solving, 4 treatments in the area of planning and analysing. Patients in the control group will recieve conventional occupational therapy treatment: 3 weeks of all together 12 sessions, 45 minutes each. The outcome measures are: a disability measure, the Functional Independence Measure (FIM), the motor FIM, the Montebello Rehabilitation Factor Score (MRFS), also called motor FIM effectiveness. In addition 4 cognitive functional measures: the Color Trail Test, the Kettle Test, the Groningen Activity Restriction Skill (GARS), the Montreal Cognitive Assessment (MOCA). The randomization process will be carried out by withdrawing a piece of paper written either A (intervention) (n=10) or B (control) (n=10) from an envelope. The subjects will not be informed as to which group they will be assigned. Patient recruitment and the randomization process will be supervised by the clinical staff. The assessors will be blinded to the type of intervention. Statistical analysis will be performed using the IBM SPSS Statistics for Windows (Version 25.0. Armonk, NY: IBM Corp.). The study sample size was estimated using the mean and the standard deviation of the motor FIM measure (calculated for this population), with improvement assumption by 7 points, with power of 0.8 and significance level of 0.05.

Official Title
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Can Specific Cognitive Intervention With Post-Acute Cognitively Impaired Hip Fracture Patients Improve Rehabilitation Outcome

Conditions
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Hip Fracture, Rehabilitation, Cognitive Intervention

Intervention / Treatment
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* Other: specific cognitive intervention
* Other: conventional occupational therapy treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All concecutive hip fracture patients admitted to a post-acute rehabilitation ward Mini mental state examination above 17 Lived at home before the fracture and did not recieved 24 hour home aid Exclusion Criteria: Patients who will not complete rehabilitation program due to worsening of their medical condition or unexpectedly cease rehabilitation will be omitted from the statistical analyses.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized double blinded study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>Patients in the control group will recieve conventional occupational therapy treatment: 3 weeks of all together 12 sessions, 45 minutes each. | Other: conventional occupational therapy treatment<br>* The intervention will include all together 12 sessions of conventional occupational therapy treatments, each being 45 minutes, for a total of 3 weeks.<br>|
| Experimental: Intervention group<br>The intervention will include all together 12 sessions, each being 45 minutes, for a total of 3 weeks. The intervention will include: 4 treatments in the area of memory and attention, 4 treatments in the area of problem solving, 4 treatments in the area of planning and analysing. | Other: specific cognitive intervention<br>* The intervention will include all together 12 sessions, each being 45 minutes, for a total of 3 weeks. The intervention will include: 4 treatments in the area of memory and attention, 4 treatments in the area of problem solving, 4 treatments in the area of planning and analysing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measure (FIM) | The FIM is a disability measure, administered on admission and upon discharge to assess change in functional abilities. The FIM comprises 18 parameters, each rated on a scale of 1 to 7 according to the degree of assistance required to perform a specific activity in 3 domains: activities of daily living (ADL) (8 parameters), mobility level (5 parameters) and cognitive function (5 parameters). The maximal total score for the FIM is 126. The patient's FIM score will be assessed during multi-disciplinary team meeting | The change in the measure from randomization until the date of discharge, assessed up 3 months. | 
| motor Functional Independence Measure (mFIM) | The motor FIM (mFIM) includes 13 parameters of ADL and mobility. maximal total score for the mFIM is 91. The patient's motor FIM score was assessed during multi-disciplinary team meeting | The change in the measure from randomization until the date of discharge, assessed up 3 months. | 
| The Montebello Rehabilitation Factor Score (MRFS) | The MRFS achieved on the mFIM score is calculated by the Montebello Rehabilitation Factor Score (MRFS), designed to overcome the floor and ceiling effect problem and calculate each patient's specific potential for improvement. The MRFS also known as mFIM effectiveness, will be calculated as the mFIM score change (discharge mFIM score-admission mFIM score) divided by the mFIM maximum score (91) minus the mFIM admission score. | The score will be calculated at discharge, assessed up to 3 months from randomization. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Color Trail Test | Assesses attention and visual perception and flexible thinking | The change in the measure from admission and upon completion of the intervention protocol (3 weeks). | 
| Kettle Test | Assesses working memory, attention, problem solving, praxis and safety | The change in the measure from admission and upon completion of the intervention protocol (3 weeks). | 
| Groningen Activity Restriction Scale | Assesses level of disability. This tool is comrised of 18 parameters each rated on a scale of 1 to 5. A low score shows higher functional level | The change in the measure from admission and upon completion of the intervention protocol (3 weeks). | 
| Montreal Cognitive Assessement (MOCA) | Assesses basic and executive cognitive skills. This tool includes 5 points related to executive function, 3 points to naming, 6 points to attention, 3 points to language use, 2 points to abstract thinking, 5 points to short term memory and 6 points to orientation. A score of 26 points and above shows normal cognitive functioning. | The change in the measure from admission and upon completion of the intervention protocol (3 weeks). | 
| EQ-5D (EuroQol Group) | EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. It ia applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys. EQ-5D is designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics, and in face-to-face interviews. It is cognitively undemanding, taking only a few minutes to complete. | The change in the measure from admission and upon completion of the intervention protocol (3 weeks). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive, Intervention, Hip fracture, Rehabilitation, outcomes