Clinical trial NCT06066788: Cognitive Strategies for Improving Health Outcomes And Managing Risk Post-Stroke
Official title: Cognitive Strategies for Improving Health Outcomes And Managing Risk Post-Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Occupational therapy
Cognitive Orientation to daily Occupational Performance
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Social Sciences Wait-list control feasibility study
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. primary diagnosis of acute ischemic stroke within 90 days
2. impairment of executive function (score \>11 on Executive Interview)
3. absence of severe aphasia (score of 0 or 1 on NIHSS will be included)
4. absence of pre-stroke dementia (per client report)
5. absence of major depressive disorder (PHQ-9 \<14, Generalized Anxiety Disorder-7)
6. absence of drug and alcohol misuse within 3 months of study admission (AUDIT)
7. access to video-conference software on computer or device like computer tablet or smart phone
8. \>18 years of age

Exclusion Criteria:

* Not fluent in English

Primary outcomes:
measure: Suitability and Feasibility Survey
timeFrame: 6 months
measure: Battery of American Heart Association Life's Essential 8
timeFrame: 6 months
Secondary outcomes:
measure: NIH Stroke Scale
timeFrame: 6 months
measure: Stroke Specific Quality of Life Scale
timeFrame: 6 months
measure: Healthcare utilization Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: UNM Health Sciences
state: New Mexico
Study officials:
References:
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.
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.
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.
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.