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

NCT ID: NCT06066788

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2024-09-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Social Sciences Wait-list control feasibility study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Feasibility Arm

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.

Group Type OTHER

CHAMPS

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CHAMPS

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cognitive Orientation to daily Occupational Performance

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Timothy P Dionne

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UNM Health Sciences

Albuquerque, New Mexico, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30676883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9479660 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36542071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34933125 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HRRC ID 23-332

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Self-Management in Stroke Survivors
NCT01875094 COMPLETED PHASE1/PHASE2