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

NCT06066788 | Completed

• 1 other identifier: HRRC ID 23-332
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Occupational therapy; Cognitive Orientation to daily Occupational Performance

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• 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?

  6 months

Secondary Outcomes (3)

• NIH Stroke Scale

  6 months

• Stroke Specific Quality of Life Scale

  6 months

• Healthcare utilization Questionnaire

  6 months

Study Arms (1)

Feasibility Arm

OTHER

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.

Other: CHAMPS

Interventions

CHAMPS 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.

Also known as: Cognitive Orientation to daily Occupational Performance

Feasibility Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not fluent in English

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

UNM Health Sciences

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (4)

• 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.

  PMID: 30676883 BACKGROUND

• 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.

  PMID: 9479660 BACKGROUND

• 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.

  PMID: 36542071 BACKGROUND

• 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.

  PMID: 34933125 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Social Sciences Wait-list control feasibility study

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: October 4, 2023
• Study Start: February 15, 2024
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)