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

NCT05487144 | Completed

• 1 other identifier: HSC-SN-21-1005
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

depression; anxiety

Outcome Measures

Primary Outcomes (9)

• Feasibility as assessed by the number of participants enrolled in the study

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

  post intervention (8 weeks from baseline of last participant )

• Feasibility as assessed by the number of participants who complete the study

  post intervention (8 weeks from baseline of last participant )

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

  post intervention (8 weeks from baseline of last participant )

• Usability as assessed by the perceived usefulness score

  post intervention (8 weeks from baseline)

• Usability as assessed by the perceived ease of use scores

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

  post intervention (8 weeks from baseline)

• Usability as assessed by the number of times the participants log in

  post intervention (8 weeks from baseline)

• Usability as assessed by the time spent in the environment in minutes

  post intervention (8 weeks from baseline)

• Acceptability as assessed by the number of VE Meetings attended

  post intervention (8 weeks from baseline)

• Acceptability as assessed by the number of VE objects manipulated

  Objects manipulated are the resources interacted with

  post intervention (8 weeks form baseline)

Secondary Outcomes (10)

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

  Baseline, post intervention (8 weeks after baseline)

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

  Baseline, post intervention (8 weeks after baseline)

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

  Baseline, post intervention (8 weeks after baseline)

• Change in loneliness as assessed by the UCLA loneliness scale scores

  Baseline, post intervention (8 weeks after baseline)

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

  Baseline, post intervention (8 weeks after baseline)

Study Arms (1)

Treatment

EXPERIMENTAL

Behavioral: Learning in a Virtual Environment (LIVE)

Interventions

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.

Treatment

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Beauchamp JES, Wang M, Leon Novelo LG, Cox C, Meyer T, Fagundes C, Savitz SI, Sharrief A, Dishman D, Johnson C. Feasibility and user-experience of a virtual environment for social connection and education after stroke: A pilot study. J Stroke Cerebrovasc Dis. 2024 Feb;33(2):107515. doi: 10.1016/j.jstrokecerebrovasdis.2023.107515. Epub 2023 Dec 7.

  PMID: 38064972 DERIVED

MeSH Terms

Conditions

Stroke; Depression; Anxiety Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Jennifer Beauchamp, PhD, RN

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

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: Associate Professor

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: April 27, 2022
• Primary Completion: November 18, 2022
• Study Completion: November 18, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)