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

Stroke Clinical Trial

— SUPPORT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05487144
• Other study ID #: HSC-SN-21-1005
• Status: Completed
• Phase: N/A
• Start date: April 27, 2022
• Est. completion date: November 18, 2022

Study information

• Verified date: January 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 18, 2022
• Est. primary completion date: November 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 )
Primary	Feasibility as assessed by the number of participants who complete the study		post intervention (8 weeks from baseline of last participant )
Primary	Feasibility as assessed by the number of participants who complete the data collection forms		post intervention (8 weeks from baseline of last participant )
Primary	Usability as assessed by the perceived usefulness score		post intervention (8 weeks from baseline)
Primary	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)
Primary	Usability as assessed by the number of times the participants log in		post intervention (8 weeks from baseline)
Primary	Usability as assessed by the time spent in the environment in minutes		post intervention (8 weeks from baseline)
Primary	Acceptability as assessed by the number of VE Meetings attended		post intervention (8 weeks from baseline)
Primary	Acceptability as assessed by the number of VE objects manipulated	Objects manipulated are the resources interacted with	post intervention (8 weeks form baseline)
Secondary	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	Baseline, post intervention (8 weeks after baseline)
Secondary	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	Baseline, post intervention (8 weeks after baseline)
Secondary	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	Baseline, post intervention (8 weeks after baseline)
Secondary	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	Baseline, post intervention (8 weeks after baseline)
Secondary	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	Baseline, post intervention (8 weeks after baseline)
Secondary	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	Baseline, post intervention (8 weeks after baseline)
Secondary	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	Baseline, post intervention (8 weeks after baseline)
Secondary	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	Baseline, post intervention (8 weeks after baseline)
Secondary	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?	Baseline, post intervention (8 weeks after baseline)
Secondary	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	Baseline, post intervention (8 weeks after baseline)