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Improving the Rehabilitation Process

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03865758
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Presbyterian SeniorCare Network
Information provided by (Responsible Party):
Steven Zarit, Penn State University

Brief Summary:

A major challenge in care of persons with dementia is that illness and hospitalizations can lead to significant decreases in functional abilities. Maintaining functional abilities as high as possible is a key goal in dementia care, because persons are able to function optimally despite cognitive problems and engage in more preferred and enjoyable activities. Functional decline can be ameliorated through rehabilitation, building strength, balance and functional competencies. People with dementia, however, may not able to engage fully in rehabilitation due to their cognitive problems. They may not understand the therapist's instructions and may be fearful of what the therapist is trying to do.

The proposed study will test the efficacy of a multifunctional interactive computer system, the IN2L, that uses video and audio to engage people more fully in rehabilitation. Music and videos elicit and sustain responses that contribute to rehabilitation goals such as increasing balance or strength. With the IN2L, audio and video material that matches the preferences and past experience of the person in rehabilitation can be selected. While this approach shows promise with rehabilitation patients generally, it has particular potential for application with persons with dementia. Specifically, when Physical or Occupational Therapists (PT and OT) are not able to engage a person with dementia in rehabilitation tasks using verbal instructions and explanations, they may be able to involve the person using audio and video stimuli that draw upon abilities that have remained intact despite the disease.

To determine the efficacy of IN2L, the study will use a quasi-experimental design that compares rehabilitation patients with dementia seen at two comparable facilities operated by Presbyterian Senior Care Network. In one facility, the Willows, OT and PT currently use IN2L. In the comparison facility, (Southmont), OT and PT do not currently have access to IN2L. This type of design is optimal, because it prevents contamination effects that could occur with random assignment within the same facility. In that case, therapists in the control condition who were working side-by-side with therapists using IN2L would be likely to incorporate IN2L techniques in their therapy sessions if they perceived it to be useful.

The study will use observational and self-report by patients and their therapists measures to determine if persons with dementia in rehabilitation show greater participation in rehabilitation activities, better attainment of rehabilitation goals and functional improvement when therapists use the IN2L compared to usual therapy approaches.

Condition or disease Intervention/treatment Phase
Dementia Device: IN2L computer system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will use a quasi-experimental design, comparing patients from two similar rehabilitation units operated by the same organization who have similar patient populations.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving the Rehabilitation Process
Actual Study Start Date : March 31, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IN2L enhanced therapy
The intervention to be delivered is the use of the IN2L computer system to deliver video, music, and exercises to patients receiving physical and occupational therapy. Therapists will select the specific IN2L that will be most appropriate given each person's rehabilitation goals and personal preferences.
Device: IN2L computer system
Therapists will use the IN2L computer system to choose videos, music, games and exercise specific to the rehabilitation needs and personal preferences of patients.

No Intervention: Usual OT and PT services without IN2L
The intervention to be delivered is physical therapy and occupational therapy to improve functioning.

Primary Outcome Measures :
  1. Pittsburgh Rehabilitation Participation Scale (PRPS) [ Time Frame: The PRPS is scored on multiple occasions for each subject following completion of OT and PT sessions from the time of enrollment in the study until treatment completion (on average 10 days). ]
    Measures change in engagement in therapy from the beginning to the end of rehabilitation. Scores range from 0--no engagement to 5--excellent engagement. Higher scores indicate a better outcome. There are no subscales.

  2. Functional Independence Scale [ Time Frame: The Functional Independence Scale is administered two times: prior to treatment and again at the completion of treatment (on average 10 days later) ]
    Measures change in functioning independence of patients from beginning to end of treatment. The scale consists of 42 items that are each rated using a reliable 10 point rating system. Scores on each function range from completely dependent (score of 0) to independent (score of 10). There are 2 subscales: items rated by physical therapists (13, range 0 to 130) and items rated by occupational therapists (29, range 0 to 290). Higher scores indicated better functioning.

  3. Goal Attainment: Percent of Rehabilitation Goals Attained. [ Time Frame: Scored at the completion of treatment, usually 10 days to two weeks after subjects enter the study. ]
    The measure assesses the percent of rehabilitation goals attained by patients. Goals are set by OT and PT at initial assessment. Attainment is determined based on comparison of Functional Independent scores at baseline and completion of treatment. Scores for goal attainment are: (1) did not attain goal; (2) attained goal; and (3) exceeded goal. The number of goals set initially varies across patients. For that reason, goal attainment scores will be summed for each person and the sum then divided by the number of goals that were initially set. This creates a comparable score across persons, which has a range from 1 to 3. Analyses will be conducted using this mean-item score for goals. Secondary analyses will look at the mean-item score for goals set by PTs and by OTs separately.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Probable dementia indicated by prior diagnosis and/or a score of 23 or less on the Brief Alzheimer Screen.

Exclusion Criteria:

  • No evidence of dementia

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 identifier (NCT number): NCT03865758

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Contact: Steven H Zarit, Ph.D. 814-571-5568

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United States, Pennsylvania
Presbytyerian SeniorCare Recruiting
Oakmont, Pennsylvania, United States, 15139
Contact: Carrie Chiusano    412-826-6065   
Presbyterian SeniorCare Southmont Recruiting
Washington, Pennsylvania, United States, 15301
Contact: Dan Sekora    724-223-5729   
Sponsors and Collaborators
Penn State University
Presbyterian SeniorCare Network

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Responsible Party: Steven Zarit, Distinguished Professor Emeritus, Penn State University Identifier: NCT03865758     History of Changes
Other Study ID Numbers: 00007754
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
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 Steven Zarit, Penn State University:

Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders