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

University of New Mexico (UNM)

Status: Completed

Conditions: Stroke

Treatments: Other: CHAMPS

Study type: Interventional

Funder types: Other

Identifiers

NCT06066788

HRRC ID 23-332

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Feasibility Arm

Other group

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.

Treatment:

Other: CHAMPS