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Completed

NCT Number: NCT05487144

Self-management EdUcation and SuPport to Promote PsychOsocial Health Among StRoke Survivors and Informal Caregivers in a VirTual Stroke Community (SUPPORT)

The purpose of this study is to create a virtual stroke community for stroke survivors and informal caregivers of stroke survivors by customizing an existing VE intervention to incorporate real-time, stroke-specific, psychosocial self management education (SME) and social interactions, to test feasibility, acceptability, and usability of the customized intervention for stroke survivors and informal caregivers of stroke survivors and to obtain and explore data to derive evidence-based hypotheses and properly design and conduct a future, larger trial to demonstrate treatment efficacy.

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Key information

Conditions

Stroke Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Mental Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stroke survivors that have experienced an ischemic or hemorrhagic stroke event and their caregivers
  • can read, write, and speak English
  • are able to provide written consent
  • are computer literate (have used a computer for ≥1 month)
  • have access to a computer with broadband internet at home
  • understand how to use the Internet (accessed the Internet on ≥2 occasions)

Exclusion criteria

  • reside outside of the home
  • Montreal Cognitive Assessment score of <9 indicating moderate to severe impairment
  • Caregivers that provide long-distance care. I

Treatment and study plan

Learning in a Virtual Environment (LIVE)

Behavioral

Phase 1 of the study will be a one-time meeting, either remote or in-person to complete V.E. training and fill out questionnaires. Phase 2 of the study is the 8 week intervention implementation.Participants will access the V.E. community from their homes on a computer with broadband internet. During the first four weeks of the intervention, participants will be required to come into the V.E. at least once per week for at least one hour. For the last four weeks, V.E. participation is strongly encouraged, but not required. The content in the V.E. will focus on psychosocial health and stroke recovery, and the messaging in the VE will be updated bi-weekly to encourage retention and engagement. Group meetings led by the study PI, a psychologist, or another trained member of the research team at least once a week will be offered. During the intervention period, VE-specific data will be collected continuously. Phase 3, will include a survey and a focus group interview via online platform.

Primary outcomes

  1. Feasibility as assessed by the number of participants enrolled in the study

    Time frame: post intervention (8 weeks from baseline of last participant )

    This will be defined as the number enrolled divided by the number of eligible individuals screened

  2. Feasibility as assessed by the number of participants who complete the study

    Time frame: post intervention (8 weeks from baseline of last participant )

  3. Feasibility as assessed by the number of participants who complete the data collection forms

    Time frame: post intervention (8 weeks from baseline of last participant )

  4. Usability as assessed by the perceived usefulness score

    Time frame: post intervention (8 weeks from baseline)

  5. Usability as assessed by the perceived ease of use scores

    Time frame: post intervention (8 weeks from baseline)

    This has 10 items, each scored form 1(strongly disagree) to 5(strongly agree), higher score meaning higher perceived ease of use

  6. Usability as assessed by the number of times the participants log in

    Time frame: post intervention (8 weeks from baseline)

  7. Usability as assessed by the time spent in the environment in minutes

    Time frame: post intervention (8 weeks from baseline)

  8. Acceptability as assessed by the number of VE Meetings attended

    Time frame: post intervention (8 weeks from baseline)

  9. Acceptability as assessed by the number of VE objects manipulated

    Time frame: post intervention (8 weeks form baseline)

    Objects manipulated are the resources interacted with

Secondary outcomes

  1. Change in perceived social support as assessed by the Multidimensional Scale of Perceived Social Support (MSPSS)

    Time frame: Baseline, post intervention (8 weeks after baseline)

    This is a 12 item scale , each question is scored from 1(very strongly disagree) to 7(very strongly agree) for a maximum score of score of 84, a higher number indicating more social support

  2. Change in post stroke depression as assessed by the Patient Health Questionnaire-9 score (PHQ-9)

    Time frame: Baseline, post intervention (8 weeks after baseline)

    This is a 9 item questionnaire, each scored from 0(not at all) to 3(nearly every day), a higher number indication g more depression

  3. Change in anxiety as assessed by the Generalized Anxiety Disorder-7 score

    Time frame: Baseline, post intervention (8 weeks after baseline)

    This is a 7 item questionnaire, each is scored from 0(not at all) to 3(nearly every day) a higher number indicating more anxiety

  4. Change in loneliness as assessed by the UCLA loneliness scale scores

    Time frame: Baseline, post intervention (8 weeks after baseline)

    This is a 20 item questionnaire, each one is scored form 1(never) to 4(always). Scores for questions 1,5,6,9,10,15,16,19 and 20 are reversed(i.e. 1=4,2=3,3=2,4=1)and the scores for each item is then summed together, higher number indicating more loneliness

  5. Change in caregiver burden as assessed by the Zarit Burden Interview (ZBI)

    Time frame: Baseline, post intervention (8 weeks after baseline)

    This is a 22 item questionnaire,each one scored from 0(never)-4(nearly always) higher core indicating more burden

  6. Change in self efficacy ( ability to perform tasks or behaviors) as assessed by the PROMIS General Self-efficacy Form

    Time frame: Baseline, post intervention (8 weeks after baseline)

    This is a 10 item questionnaire, each one is scored from 1(not at all true) to 4(exactly true), a higher number indicating a better outcome

  7. Change in emotional support as assessed by the NIH Emotional Support Form

    Time frame: Baseline, post intervention (8 weeks after baseline)

    This is an 8 item questionnaire, and each is scored form 1(never)-5(always), for a maximum score of 40, a higher number indicating higher levels of emotional support

  8. Change in instrumental support as assessed by the PROMIS Short Form v2.0

    Time frame: Baseline, post intervention (8 weeks after baseline)

    This is an 8 item questionnaire, and each is scored form 1(never)-5(always), for a maximum score of 40, a higher number indicating higher levels of instrumental support

  9. Change in ability to recover form stress as measured by the Brief Resilience Scale

    Time frame: Baseline, post intervention (8 weeks after baseline)

    This is a 6 item questionnaire scored from 1 (strongly disagree) to 5 (strongly agree) a higher number indicating a better outcome?

  10. Change in the amount that pain interferes with daily life as assessed by the PROMIS Short Form Pain Interference v 1.0 8a

    Time frame: Baseline, post intervention (8 weeks after baseline)

    This is an 8 item questionnaire and each is scored from 1 (not at all) to 5 (very much) a higher number indicating a worse outcome

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Self-management EdUcation and SuPport to Promote PsychOsocial Health Among StRoke Survivors and Informal Caregivers in a VirTual Stroke Community (SUPPORT): A Pilot Project

Acronym: SUPPORT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 4, 2022
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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