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

NCT ID: NCT05487144

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-27
• Study Completion Date: 2022-11-18

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment

Group Type: EXPERIMENTAL

Learning in a Virtual Environment (LIVE)

Intervention Type: 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.

Interventions

Learning in a Virtual Environment (LIVE)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Beauchamp

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Beauchamp, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38064972 (View on PubMed)

Other Identifiers

HSC-SN-21-1005

Identifier Type: -

Identifier Source: org_study_id