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Cognitive Strategies for Improving Health Outcomes And Managing Risk Post-Stroke (CHAMPS)

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CHAMPS
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Occupational therapy, Cognitive Orientation to daily Occupational Performance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: primary diagnosis of acute ischemic stroke within 90 days impairment of executive function (score >11 on Executive Interview) absence of severe aphasia (score of 0 or 1 on NIHSS will be included) absence of pre-stroke dementia (per client report) absence of major depressive disorder (PHQ-9 <14, Generalized Anxiety Disorder-7) absence of drug and alcohol misuse within 3 months of study admission (AUDIT) access to video-conference software on computer or device like computer tablet or smart phone >18 years of age Exclusion Criteria: Not fluent in English

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Feasibility Arm

    Arm Description

    A 10 sessions over 5 week virtual interaction between an occupational therapist and a person who is post-stroke, engage in meta-cognitive coaching to develop strategies to overcome barriers to daily living experienced in early stages of stroke. Outcomes anticipated are related to the American Heart Association's Healthy 8.

    Outcomes

    Primary Outcome Measures

    Suitability and Feasibility Survey
    This survey will be conducted at the conclusion of study, to be completed by participants, examining whether this intervention is suitable and that the research protocols are feasible to be administered.
    Battery of American Heart Association Life's Essential 8
    A battery of measures asking about the following: Blood pressure Weight and Height (BMI) Blood sugar questions: Recently, has your doctor talked to you about managing your A1C? Cholesterol, Cholesterol is a fatty substance found in the blood. About how long has it been since you last had your cholesterol checked? Have you ever been told by a doctor, nurse or other health professional that your cholesterol is high? Are you currently taking medicine prescribed by your doctor or other health professional for your cholesterol? Smoking, recently, have you smoked or been around anyone who has smoked tobacco products? Physical Activity, How active do you consider yourself? At least 150 minutes a week to be considered active Sleep, How would you describe your sleep? Diet, How would describe your diet?

    Secondary Outcome Measures

    NIH Stroke Scale
    National Health Stroke Scale: 15 items assessing severity of impairment in LOC, ability to respond to questions and obey simple commands, papillary response, deviation of gaze, extent of hemianopsia, facial palsy, resistance to gravity in the weaker limb, plantar reflexes, limb ataxia, sensory loss, visual neglect, dysarthria and aphasia severity. Items are graded on a 3- or 4-point ordinal scale; 0 means no impairment. Scores range from 0 - 42. Higher scores indicate greater severity. Very Severe: >25 Severe: 15 - 24 Mild to Moderately Severe: 5 - 14 Mild: 1 - 5
    Stroke Specific Quality of Life Scale
    A quality of life measure designed for stroke subjects. 49 items Items are assessed on 5-point Guttman-type scales. Each item is answered using 1 of 3 different response sets. Provides both summary and domain specific scores: Domain scores are composed of unweighted averages Summary scores are composed of an unweighted average of the 12 domain average scores Scores range from 49-245. Higher scores indicate better functioning. The 12 domains include: Mobility Energy Upper Extremity Function Work and Productivity Mood Self-care Social Roles Family Roles Vision Language Thinking Personality
    Healthcare utilization Questionnaire
    An informal questionnaire regarding unanticipated hospitalization, to be completed by participants at the end of the study.

    Full Information

    First Posted
    September 12, 2023
    Last Updated
    October 24, 2023
    Sponsor
    University of New Mexico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06066788
    Brief Title
    Cognitive Strategies for Improving Health Outcomes And Managing Risk Post-Stroke
    Acronym
    CHAMPS
    Official Title
    Cognitive Strategies for Improving Health Outcomes And Managing Risk Post-Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    June 29, 2024 (Anticipated)
    Study Completion Date
    December 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of New Mexico

    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 proposed research will further develop the CHAMPS intervention which is self-management intervention to learn new skills, despite current health status of experience a stroke. The study seeks to determine feasibility and compare pre- to post-intervention change including cardiovascular risk, quality of life, self-efficacy, recurrent stroke, hospital readmission, and perceived decline in health and function.
    Detailed Description
    People living with the effects of stroke frequently require assistance with everyday tasks (e.g., dressing, managing medications, driving) well-beyond 90-days post stroke. Executive function (EF) deficits are a major contributor to disability and as many as 75% of stroke survivors present with EF deficits. EF is a collection of cognitive processes that include orienting towards the future (i.e. planning), demonstrating self-control (i.e. behavioral inhibition), problem-solving, adapting to environmental changes, and facilitating goal-directed behaviors, all of which are essential skills for managing health. EF deficits are frequently undetected during hospitalization and result in discharge to the community with as many as 71% of survivors receiving inadequate services for long-term needs. Furthermore, scales of neurological impairment for classifying stroke severity like the NIH Stroke Scale (NIHSS) are frequently used as a standard of care and also sometimes support identification of impairments. However, research previously conducted by the research team indicates that this goes beyond the intended scope of the tools and scales like the NIHSS do not relate to EF deficits thus resulting in inadequate rehabilitation referrals if another EF screening or assessment is not used. Persons with post-stroke EF deficits have a multitude of modifiable risk factors that require intervention beyond regular health advice only. Consequently, the demand for specialized interventions to prevent and mitigate negative health outcomes (e.g., recurrent stroke, cardiovascular disease risk, cognitive decline risk, hospital readmission) in this population is quickly expanding and offers a significant opportunity for supporting recovery and improving quality of life for people with stroke. Although lifestyle-based vascular risk factor reduction interventions are numerous, there is a lack of consideration for targeting cognitive factors that can influence real-world application.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Occupational therapy, Cognitive Orientation to daily Occupational Performance

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Social Sciences Wait-list control feasibility study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Feasibility Arm
    Arm Type
    Other
    Arm Description
    A 10 sessions over 5 week virtual interaction between an occupational therapist and a person who is post-stroke, engage in meta-cognitive coaching to develop strategies to overcome barriers to daily living experienced in early stages of stroke. Outcomes anticipated are related to the American Heart Association's Healthy 8.
    Intervention Type
    Other
    Intervention Name(s)
    CHAMPS
    Other Intervention Name(s)
    Cognitive Orientation to daily Occupational Performance
    Intervention Description
    Cognitive Orientation to daily Occupational Performance is a performance-based treatment approach for children and adults who experience difficulties performing the skills they want to, need to or are expected to perform. Cognitive Orientation to daily Occupational Performance is a specifically tailored, active client-centered approach that engages the individual at the meta-cognitive level to solve performance problems. Focused on enabling success, the Cognitive Orientation to daily Occupational Performance Approach employs collaborative goal setting, dynamic performance analysis, cognitive strategy use, guided discovery, and enabling principles. These elements, all considered essential to the Cognitive Orientation to daily Occupational Performance Approach, are situated within a structured intervention format, and with parent/significant other involvement as appropriate.
    Primary Outcome Measure Information:
    Title
    Suitability and Feasibility Survey
    Description
    This survey will be conducted at the conclusion of study, to be completed by participants, examining whether this intervention is suitable and that the research protocols are feasible to be administered.
    Time Frame
    6 months
    Title
    Battery of American Heart Association Life's Essential 8
    Description
    A battery of measures asking about the following: Blood pressure Weight and Height (BMI) Blood sugar questions: Recently, has your doctor talked to you about managing your A1C? Cholesterol, Cholesterol is a fatty substance found in the blood. About how long has it been since you last had your cholesterol checked? Have you ever been told by a doctor, nurse or other health professional that your cholesterol is high? Are you currently taking medicine prescribed by your doctor or other health professional for your cholesterol? Smoking, recently, have you smoked or been around anyone who has smoked tobacco products? Physical Activity, How active do you consider yourself? At least 150 minutes a week to be considered active Sleep, How would you describe your sleep? Diet, How would describe your diet?
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    NIH Stroke Scale
    Description
    National Health Stroke Scale: 15 items assessing severity of impairment in LOC, ability to respond to questions and obey simple commands, papillary response, deviation of gaze, extent of hemianopsia, facial palsy, resistance to gravity in the weaker limb, plantar reflexes, limb ataxia, sensory loss, visual neglect, dysarthria and aphasia severity. Items are graded on a 3- or 4-point ordinal scale; 0 means no impairment. Scores range from 0 - 42. Higher scores indicate greater severity. Very Severe: >25 Severe: 15 - 24 Mild to Moderately Severe: 5 - 14 Mild: 1 - 5
    Time Frame
    6 months
    Title
    Stroke Specific Quality of Life Scale
    Description
    A quality of life measure designed for stroke subjects. 49 items Items are assessed on 5-point Guttman-type scales. Each item is answered using 1 of 3 different response sets. Provides both summary and domain specific scores: Domain scores are composed of unweighted averages Summary scores are composed of an unweighted average of the 12 domain average scores Scores range from 49-245. Higher scores indicate better functioning. The 12 domains include: Mobility Energy Upper Extremity Function Work and Productivity Mood Self-care Social Roles Family Roles Vision Language Thinking Personality
    Time Frame
    6 months
    Title
    Healthcare utilization Questionnaire
    Description
    An informal questionnaire regarding unanticipated hospitalization, to be completed by participants at the end of the study.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: primary diagnosis of acute ischemic stroke within 90 days impairment of executive function (score >11 on Executive Interview) absence of severe aphasia (score of 0 or 1 on NIHSS will be included) absence of pre-stroke dementia (per client report) absence of major depressive disorder (PHQ-9 <14, Generalized Anxiety Disorder-7) absence of drug and alcohol misuse within 3 months of study admission (AUDIT) access to video-conference software on computer or device like computer tablet or smart phone >18 years of age Exclusion Criteria: Not fluent in English
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tim Dionne, PhD
    Phone
    5052720639
    Email
    tdionne@salud.unm.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suzanne Burns, PhD
    Phone
    505-272-2321
    Email
    scburns@salud.unm.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    None will be shared
    Citations:
    PubMed Identifier
    30676883
    Citation
    Shea-Shumsky NB, Schoeneberger S, Grigsby J. Executive functioning as a predictor of stroke rehabilitation outcomes. Clin Neuropsychol. 2019 Jul;33(5):854-872. doi: 10.1080/13854046.2018.1546905. Epub 2019 Jan 24.
    Results Reference
    background
    PubMed Identifier
    9479660
    Citation
    Spilker J, Kongable G, Barch C, Braimah J, Brattina P, Daley S, Donnarumma R, Rapp K, Sailor S. Using the NIH Stroke Scale to assess stroke patients. The NINDS rt-PA Stroke Study Group. J Neurosci Nurs. 1997 Dec;29(6):384-92. doi: 10.1097/01376517-199712000-00008.
    Results Reference
    background
    PubMed Identifier
    36542071
    Citation
    Skidmore ER, Eskes G, Brodtmann A. Executive Function Poststroke: Concepts, Recovery, and Interventions. Stroke. 2023 Jan;54(1):20-29. doi: 10.1161/STROKEAHA.122.037946. Epub 2022 Dec 21.
    Results Reference
    background
    PubMed Identifier
    34933125
    Citation
    Small R, Wilson PH, Wong D, Rogers JM. Who, what, when, where, why, and how: A systematic review of the quality of post-stroke cognitive rehabilitation protocols. Ann Phys Rehabil Med. 2022 Sep;65(5):101623. doi: 10.1016/j.rehab.2021.101623. Epub 2022 Mar 5.
    Results Reference
    background

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