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

January 8, 2023 updated by: Jennifer Beauchamp, The University of Texas Health Science Center, Houston

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
post intervention (8 weeks from baseline of last participant )
Feasibility as assessed by the number of participants who complete the study
Time Frame: post intervention (8 weeks from baseline of last participant )
post intervention (8 weeks from baseline of last participant )
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 )
post intervention (8 weeks from baseline of last participant )
Usability as assessed by the perceived usefulness score
Time Frame: post intervention (8 weeks from baseline)
post intervention (8 weeks from baseline)
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
post intervention (8 weeks from baseline)
Usability as assessed by the number of times the participants log in
Time Frame: post intervention (8 weeks from baseline)
post intervention (8 weeks from baseline)
Usability as assessed by the time spent in the environment in minutes
Time Frame: post intervention (8 weeks from baseline)
post intervention (8 weeks from baseline)
Acceptability as assessed by the number of VE Meetings attended
Time Frame: post intervention (8 weeks from baseline)
post intervention (8 weeks from baseline)
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
post intervention (8 weeks form baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline, post intervention (8 weeks after baseline)
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
Baseline, post intervention (8 weeks after baseline)
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
Baseline, post intervention (8 weeks after baseline)
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
Baseline, post intervention (8 weeks after baseline)
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
Baseline, post intervention (8 weeks after baseline)
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
Baseline, post intervention (8 weeks after baseline)
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
Baseline, post intervention (8 weeks after baseline)
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
Baseline, post intervention (8 weeks after baseline)
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?
Baseline, post intervention (8 weeks after baseline)
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
Baseline, post intervention (8 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Beauchamp, PhD, RN, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-SN-21-1005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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