Post-stroke Psychosocial Recovery

NCT05380037 | Recruiting

• 2 other identifiers: D3881-PI21RX003881-01A1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

quality of life; rehabilitation; depression; anxiety

Outcome Measures

Primary Outcomes (5)

• Qualitative report of psychosocial function

  Qualitative responses to an interview on the impact of stroke on psychosocial function in multiple domains and unmet needs for rehabilitation

  Once at cross-sectional assessment on one day for approximately 2-3 hours

• Inventory of Psychosocial Functioning

  All Veteran chronic stroke survivors will complete the self-report Inventory of Psychosocial Functioning (IPF; Rodriguez et al., 2018). The Inventory of Psychosocial Functioning is an 80-item self-report measure used to assess functional impairment across multiple psychosocial domains within the last 30 days. Items are rated in regards to frequency (never to always). Total score range=0-480, with higher scores indicating greater impairment.

  Once at cross-sectional assessment on one day for approximately 2-3 hours

• Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form

  Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form is a self-reported questionnaire, with 16 items, designed to assess overall enjoyment and satisfaction with physical health, mood, work, household and leisure activities, social and family relationships, daily functioning, sexual life, economic status, overall well-being and medications. Responses are scored on a 5-point scale ('not at all or never' to 'frequently or all the time'), where higher scores indicate better enjoyment and satisfaction with life (possible range 14-70). Fourteen summated items create the total Q-LES-Q - SF score. Two last items on medications and overall life satisfaction, are independent scores. Total score range=16-80, with higher scores indicating greater satisfaction.

  Once at cross-sectional assessment on one day for approximately 2-3 hours

• Brief-COPE

  The Brief COPE is a 28-item self-report measure of coping strategies used for responding to stressors. Items are rated on a scale from 1, I haven't been doing this at all, to 4, I've been doing this a lot. There are 14 two-item subscales within the Brief COPE, and each is analyzed separately with a score from 2 to 8 for each subscale: (1) self-distraction, (2) active coping, (3) denial, (4) substance use, (5) use of emotional support, (6) use of instrumental support, (7) behavioral disengagement, (8) venting, (9) positive reframing, (10) planning, (11) humor, (12) acceptance, (13) religion, and (14) self-blame. Higher scores indicate higher usage of that coping strategy.

  Once at cross-sectional assessment on one day for approximately 2-3 hours

• Stroke Impact Scale

  The stroke impact scale is a self-report measure of a quality of life across multiple domains of functioning since stroke.

  Once at cross-sectional assessment on one day for approximately 2-3 hours

Secondary Outcomes (5)

• Montreal Cognitive Assessment

  Once at cross-sectional assessment on one day for approximately 2-3 hours

• Mini-International Neuropsychiatric Interview

  Once at cross-sectional assessment on one day for approximately 2-3 hours

• PTSD Checklist-5

  Once at cross-sectional assessment on one day for approximately 2-3 hours

• Life Events Checklist

  Once at cross-sectional assessment on one day for approximately 2-3 hours

• Patient Health Questionnaire-9

  Once at cross-sectional assessment on one day for approximately 2-3 hours

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A single, cross-sectional qualitative assessment of 1) Veteran chronic stroke survivors (n=50), 2) their loved ones/caregivers (n=25), and 3) VA stroke rehabilitation providers (e.g., physical, speech, and occupational therapists, neurologists, neuropsychologists; n=25).

You may qualify if:

• 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:
• \) have ischemic or hemorrhagic stroke, primary intracerebral hematoma, or subarachnoid hemorrhage with at least 6 month chronicity
• \) demonstrate ability to perform the interview and complete questionnaires
• \) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

RECRUITING

Biospecimen

Retention: NONE RETAINED

None retained

MeSH Terms

Conditions

Stroke; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Lisa M. McTeague, PhD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa M McTeague, PhD

CONTACT

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

Anouk L Grubaugh, PhD MA BS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: January 9, 2023
• Primary Completion: January 13, 2025
• Study Completion: August 1, 2025
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)