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Cognitive Intervention and Rehabilitation Outcomes in Hip Fracture Patients

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ClinicalTrials.gov Identifier: NCT04626934
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
AVITAL HERSHKOVITZ, Rabin Medical Center

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

Condition or disease Intervention/treatment Phase
Hip Fracture Rehabilitation Cognitive Intervention Other: specific cognitive intervention Other: conventional occupational therapy treatment Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized double blinded study
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The patients and the team that assess the patients do not know to which group the patients have been assigned
Primary Purpose: Treatment
Official Title: Can Specific Cognitive Intervention With Post-Acute Cognitively Impaired Hip Fracture Patients Improve Rehabilitation Outcome
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: control group
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
The intervention will include all together 12 sessions of conventional occupational therapy treatments, each being 45 minutes, for a total of 3 weeks.

Experimental: Intervention group
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
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.




Primary Outcome Measures :
  1. Functional Independence Measure (FIM) [ Time Frame: The change in the measure from randomization until the date of discharge, assessed up 3 months. ]
    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

  2. motor Functional Independence Measure (mFIM) [ Time Frame: The change in the measure from randomization until the date of discharge, assessed up 3 months. ]
    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

  3. The Montebello Rehabilitation Factor Score (MRFS) [ Time Frame: The score will be calculated at discharge, assessed up to 3 months from randomization. ]
    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.


Secondary Outcome Measures :
  1. Color Trail Test [ Time Frame: The change in the measure from admission and upon completion of the intervention protocol (3 weeks). ]
    Assesses attention and visual perception and flexible thinking

  2. Kettle Test [ Time Frame: The change in the measure from admission and upon completion of the intervention protocol (3 weeks). ]
    Assesses working memory, attention, problem solving, praxis and safety

  3. Groningen Activity Restriction Scale [ Time Frame: The change in the measure from admission and upon completion of the intervention protocol (3 weeks). ]
    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

  4. Montreal Cognitive Assessement (MOCA) [ Time Frame: The change in the measure from admission and upon completion of the intervention protocol (3 weeks). ]
    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.

  5. EQ-5D (EuroQol Group) [ Time Frame: The change in the measure from admission and upon completion of the intervention protocol (3 weeks). ]
    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.



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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04626934


Contacts
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Contact: Avital Hershkovitz, MD 972522342123 avitalhe@clalit.org.il
Contact: Yedida Borow, BOT 072546441838 yedidabo@clalit.org.il

Locations
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Israel
"Beit- Rivka" geriatric rehabilitation hospital Recruiting
Petach tiqva, Israel
Contact: Avital Hershkovitz, MD-PhD    +972522342123    avitalhe@clalit.org.il   
Contact: yedida Borow, BOT    +972546441838    yedidabo@clalit.org.il   
Sponsors and Collaborators
Rabin Medical Center
Tel Aviv University
Investigators
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Principal Investigator: Avital Hershkovitz, MD Rabin MC
Publications:
Adam S, Godlwana L, Maleka D. Changes in short-term cognitive function following a hip fracture in the elderly and the effect of cognitive function on early post-operative function. SA Orthopaedic Journal 2016;15:77-82.
Hamilton BB, Granger CV, Sherwin FS, et al. A uniform national data system for medical rehabilitation. In: Fuhrer MJ, editor. Rehabilitation outcomes: analysis and measurement. Baltimore: Paul H Brooks Publishing Co; 1987. p 137-47.

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Responsible Party: AVITAL HERSHKOVITZ, Head, Geriatric Rehabilitation Ward, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT04626934    
Other Study ID Numbers: 0465-20-RMC
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AVITAL HERSHKOVITZ, Rabin Medical Center:
cognitive
Intervention
Hip fracture
Rehabilitation
outcomes
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries