Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT05380037

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Stroke is a neurological injury that adversely impacts psychosocial functioning and quality of life. This may occur due to direct insult to the brain circuits integral to adaptive psychosocial functioning, and/or indirectly via significant disruption to routine motor, sensory and cognitive performance. Yet, few evidence-based interventions exist for addressing the broad disruption to emotional and interpersonal functioning specific to stroke, highlighting a clear unmet need. The investigators propose that 1) identifying the most significant disruptions and 2) developing a cognitive-behavioral intervention to promote psychosocial functioning post-stroke is particularly important for overall quality of life, but additionally for adherence to physical rehabilitation and related interventions intended to promote holistic recovery.

Conditions

Stroke

Study ID

NCT05380037

Start date

Jan 9, 2023

Status verified date

Feb, 2024

Completion date

Aug 1, 2025

Anticipated

Primary completion date

Jan 13, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participants must be 18 years or greater and will be recruited from all racial, ethnic and gender categories.
  • Veterans with chronic stroke (n=50) must:

  • 1) have ischemic or hemorrhagic stroke, primary intracerebral hematoma, or subarachnoid hemorrhage with at least 6 month chronicity
  • 2) demonstrate ability to perform the interview and complete questionnaires
  • 3) endorse mild to severe psychosocial impairment on the Brief Inventory of Psychosocial Functioning (B-IPF; Rodriguez et al., 2018), a 7-item measure developed specifically on Veterans with impairment in important domains of daily psychosocial function
  • Caregiver/Loved ones (n=25) must be familiar with the trajectory of function and recovery of the identified Veteran with chronic stroke.
  • Rehabilitation providers (n=25) of Veterans with chronic stroke must provide stroke-related care in the VA Healthcare system including (but not limited to) physical, speech, and occupational therapists, neurologists, and neuropsychologists.

Exclusion Criteria:

  • Veterans with chronic stroke will be excluded for moderate to severe global aphasia that precludes qualitative interview completion, if those individuals cannot or do not wish to complete study procedures via written responses. (Note that to avoid limiting generalizability, these individuals will be invited to complete the questionnaire-based assessments in Aim 2).
  • Participants will also be excluded for comorbid conditions that impact recall of stroke recovery history (e.g., dementia or psychosis).
  • Caregiver/Loved ones will be excluded if the veteran stroke survivor has not provided consent for caregiver/loved one participation.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Veterans with chronic stroke

Veterans with chronic stroke (n=50) must 1) have ischemic or hemorrhagic stroke, primary intracerebral hematoma, or subarachnoid hemorrhage with at least 6 month chronicity; 2) demonstrate ability to perform the interview and complete questionnaires and 3) endorse mild to severe psychosocial impairment

Caregiver/Loved ones

Caregiver/Loved ones (n=25) must be familiar with the trajectory of function and recovery of the identified Veteran with chronic stroke

Rehabilitation providers

Rehabilitation providers (n=25) of Veterans with chronic stroke must provide stroke-related care in the VA Healthcare system including (but not limited to) physical, speech, and occupational therapists, neurologists, and neuropsychologists

Primary outcome measure

  • Qualitative report of psychosocial function [ Time Frame: Once at cross-sectional assessment on one day for approximately 2-3 hours ]
  • Inventory of Psychosocial Functioning [ Time Frame: Once at cross-sectional assessment on one day for approximately 2-3 hours ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form [ Time Frame: Once at cross-sectional assessment on one day for approximately 2-3 hours ]
  • Brief-COPE [ Time Frame: Once at cross-sectional assessment on one day for approximately 2-3 hours ]
  • Stroke Impact Scale [ Time Frame: Once at cross-sectional assessment on one day for approximately 2-3 hours ]

Central Contacts and Locations

Central contacts

Lisa M McTeague, PhD

(843) 577-5011Lisa.Mcteague@va.gov

Anouk L Grubaugh, PhD MA BS

(843) 789-6664Anouk.Grubaugh@va.gov

Locations

Ralph H. Johnson VA Medical Center, Charleston, SC

Recruiting

Charleston, South Carolina, United States, 29401-5703

Contacts

Lisa M McTeague, PhD

843-577-5011Lisa.Mcteague@va.gov

Principal Investigator:

Lisa M. McTeague, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Feb 15, 2024

Last verified

Feb, 2024

Keywords

  • quality of life
  • rehabilitation
  • depression
  • anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2024-02-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.