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Cognitive Intervention and Rehabilitation Outcomes in Hip Fracture Patients

Primary Purpose

Hip Fracture, Rehabilitation, Cognitive Intervention

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
specific cognitive intervention
conventional occupational therapy treatment
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture focused on measuring cognitive, Intervention, Hip fracture, Rehabilitation, outcomes

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • "Beit- Rivka" geriatric rehabilitation hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

Intervention group

Arm Description

Patients in the control group will recieve conventional occupational therapy treatment: 3 weeks of all together 12 sessions, 45 minutes each.

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.

Outcomes

Primary Outcome Measures

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
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 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.

Secondary Outcome Measures

Color Trail Test
Assesses attention and visual perception and flexible thinking
Kettle Test
Assesses working memory, attention, problem solving, praxis and safety
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
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.
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.

Full Information

First Posted
October 22, 2020
Last Updated
April 9, 2023
Sponsor
Rabin Medical Center
Collaborators
Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT04626934
Brief Title
Cognitive Intervention and Rehabilitation Outcomes in Hip Fracture Patients
Official Title
Can Specific Cognitive Intervention With Post-Acute Cognitively Impaired Hip Fracture Patients Improve Rehabilitation Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
Collaborators
Tel Aviv University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture, Rehabilitation, Cognitive Intervention
Keywords
cognitive, Intervention, Hip fracture, Rehabilitation, outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized double blinded study
Masking
ParticipantOutcomes Assessor
Masking Description
The patients and the team that assess the patients do not know to which group the patients have been assigned
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients in the control group will recieve conventional occupational therapy treatment: 3 weeks of all together 12 sessions, 45 minutes each.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
specific cognitive intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional occupational therapy treatment
Intervention Description
The intervention will include all together 12 sessions of conventional occupational therapy treatments, each being 45 minutes, for a total of 3 weeks.
Primary Outcome Measure Information:
Title
Functional Independence Measure (FIM)
Description
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
Time Frame
The change in the measure from randomization until the date of discharge, assessed up 3 months.
Title
motor Functional Independence Measure (mFIM)
Description
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
Time Frame
The change in the measure from randomization until the date of discharge, assessed up 3 months.
Title
The Montebello Rehabilitation Factor Score (MRFS)
Description
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.
Time Frame
The score will be calculated at discharge, assessed up to 3 months from randomization.
Secondary Outcome Measure Information:
Title
Color Trail Test
Description
Assesses attention and visual perception and flexible thinking
Time Frame
The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
Title
Kettle Test
Description
Assesses working memory, attention, problem solving, praxis and safety
Time Frame
The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
Title
Groningen Activity Restriction Scale
Description
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
Time Frame
The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
Title
Montreal Cognitive Assessement (MOCA)
Description
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.
Time Frame
The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
Title
EQ-5D (EuroQol Group)
Description
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.
Time Frame
The change in the measure from admission and upon completion of the intervention protocol (3 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avital Hershkovitz, MD
Phone
972522342123
Email
avitalhe@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yedida Borow, BOT
Phone
072546441838
Email
yedidabo@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avital Hershkovitz, MD
Organizational Affiliation
Rabin MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Beit- Rivka" geriatric rehabilitation hospital
City
Petach tiqva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avital Hershkovitz, MD-PhD
Phone
+972522342123
Email
avitalhe@clalit.org.il
First Name & Middle Initial & Last Name & Degree
yedida Borow, BOT
Phone
+972546441838
Email
yedidabo@clalit.org.il

12. IPD Sharing Statement

Plan to Share IPD
No
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Cognitive Intervention and Rehabilitation Outcomes in Hip Fracture Patients

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