Clinical trial NCT04626934: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fracture
Rehabilitation
Cognitive Intervention
Keywords: cognitive
Intervention
Hip fracture
Rehabilitation
outcomes
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2020-11-13
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double blinded study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Functional Independence Measure (FIM)
timeFrame: The change in the measure from randomization until the date of discharge, assessed up 3 months.
measure: motor Functional Independence Measure (mFIM)
timeFrame: The change in the measure from randomization until the date of discharge, assessed up 3 months.
measure: The Montebello Rehabilitation Factor Score (MRFS)
timeFrame: The score will be calculated at discharge, assessed up to 3 months from randomization.
Secondary outcomes:
measure: Color Trail Test
timeFrame: The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
measure: Kettle Test
timeFrame: The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
measure: Groningen Activity Restriction Scale
timeFrame: The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
measure: Montreal Cognitive Assessement (MOCA)
timeFrame: The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
measure: EQ-5D (EuroQol Group)
timeFrame: The change in the measure from admission and upon completion of the intervention protocol (3 weeks).
Other outcomes:
Locations:
city: Petach tiqva
country: Israel
facility: "Beit- Rivka" geriatric rehabilitation hospital
Study officials:
affiliation: Rabin MC
name: Avital Hershkovitz, MD
role: PRINCIPAL_INVESTIGATOR
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