StrokeSUPPORTNCT05487144
Self-management EdUcation and SuPport to Promote PsychOsocial Health Among StRoke Survivors and Informal Caregivers in a VirTual Stroke Community (SUPPORT)
A study testing Learning in a Virtual Environment (LIVE) in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Learning in a Virtual Environment (LIVE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2022to 18 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- reside outside of the home
- Montreal Cognitive Assessment score of <9 indicating moderate to severe impairment
- Caregivers that provide long-distance care. I
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official 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
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
- Being tested
- Learning in a Virtual Environment (LIVE)
- Keywords
- depression, anxiety
- Medical subject headings
- Stroke, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Learning in a Virtual Environment (LIVE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Behavioral: Learning in a Virtual Environment (LIVE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: post intervention (8 weeks from baseline of last participant )
Feasibility as assessed by the number of participants who complete the study
Measured: post intervention (8 weeks from baseline of last participant )
Feasibility as assessed by the number of participants who complete the data collection forms
Measured: post intervention (8 weeks from baseline of last participant )
Usability as assessed by the perceived usefulness score
Measured: 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
Measured: post intervention (8 weeks from baseline)
Usability as assessed by the number of times the participants log in
Measured: post intervention (8 weeks from baseline)
Usability as assessed by the time spent in the environment in minutes
Measured: post intervention (8 weeks from baseline)
Acceptability as assessed by the number of VE Meetings attended
Measured: post intervention (8 weeks from baseline)
Acceptability as assessed by the number of VE objects manipulated
Objects manipulated are the resources interacted with
Measured: 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)
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
Measured: Baseline, post intervention (8 weeks after baseline)
Change in post stroke depression as assessed by the Patient Health Questionnaire-9 score (PHQ-9)
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
Measured: Baseline, post intervention (8 weeks after baseline)
Change in anxiety as assessed by the Generalized Anxiety Disorder-7 score
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
Measured: Baseline, post intervention (8 weeks after baseline)
Change in loneliness as assessed by the UCLA loneliness scale scores
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
Measured: Baseline, post intervention (8 weeks after baseline)
Change in caregiver burden as assessed by the Zarit Burden Interview (ZBI)
This is a 22 item questionnaire,each one scored from 0(never)-4(nearly always) higher core indicating more burden
Measured: 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
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
Measured: Baseline, post intervention (8 weeks after baseline)
Change in emotional support as assessed by the NIH Emotional Support Form
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
Measured: Baseline, post intervention (8 weeks after baseline)
Change in instrumental support as assessed by the PROMIS Short Form v2.0
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
Measured: Baseline, post intervention (8 weeks after baseline)
Change in ability to recover form stress as measured by the Brief Resilience Scale
This is a 6 item questionnaire scored from 1 (strongly disagree) to 5 (strongly agree) a higher number indicating a better outcome?
Measured: 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
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
Measured: Baseline, post intervention (8 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start27 Apr 2022
- Primary completion18 Nov 2022
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Beauchamp, The University of Texas Health Science Center, Houston
- Investigators
- Jennifer Beauchamp, PhD, RN, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487144
- Sponsor's protocol ID
- HSC-SN-21-1005
- Acronym
- SUPPORT
- Status last verified
- Jan 2023
- First submitted
- 2 Aug 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38064972
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05487144
- Acronym / sponsor ID
- SUPPORT / HSC-SN-21-1005
- Conditions
- Stroke
- Keywords
- depression, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Learning in a Virtual Environment (LIVE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- reside outside of the home
- Montreal Cognitive Assessment score of <9 indicating moderate to severe impairment
- Caregivers that provide long-distance care. I
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Treatment |
Primary outcome
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
Feasibility as assessed by the number of participants who complete the study
Time frame: 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 )
Usability as assessed by the perceived usefulness score
Time frame: 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
Usability as assessed by the number of times the participants log in
Time frame: 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)
Acceptability as assessed by the number of VE Meetings attended
Time frame: 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
10 secondary outcomes
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)
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)
Change in anxiety as assessed by the Generalized Anxiety Disorder-7 score
Time frame: 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)
Change in caregiver burden as assessed by the Zarit Burden Interview (ZBI)
Time frame: 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)
Change in emotional support as assessed by the NIH Emotional Support Form
Time frame: 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)
Change in ability to recover form stress as measured by the Brief Resilience Scale
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Derived from this study: PubMed 38064972Beauchamp 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Beauchamp, PhD, RN principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Learning in a Virtual Environment (LIVE) in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by the number of participants enrolled in the study (time frame: post intervention (8 weeks from baseline of last participant )). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05487144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.