Clinical trial NCT05487144: Self-management EdUcation and SuPport to Promote PsychOsocial Health Among StRoke Survivors and Informal Caregivers in a VirTual Stroke Community (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: depression
anxiety
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Feasibility as assessed by the number of participants enrolled in the study
timeFrame: post intervention (8 weeks from baseline of last participant )
measure: Feasibility as assessed by the number of participants who complete the study
timeFrame: post intervention (8 weeks from baseline of last participant )
measure: Feasibility as assessed by the number of participants who complete the data collection forms
timeFrame: post intervention (8 weeks from baseline of last participant )
measure: Usability as assessed by the perceived usefulness score
timeFrame: post intervention (8 weeks from baseline)
measure: Usability as assessed by the perceived ease of use scores
timeFrame: post intervention (8 weeks from baseline)
measure: Usability as assessed by the number of times the participants log in
timeFrame: post intervention (8 weeks from baseline)
measure: Usability as assessed by the time spent in the environment in minutes
timeFrame: post intervention (8 weeks from baseline)
measure: Acceptability as assessed by the number of VE Meetings attended
timeFrame: post intervention (8 weeks from baseline)
measure: Acceptability as assessed by the number of VE objects manipulated
timeFrame: post intervention (8 weeks form baseline)
Secondary outcomes:
measure: Change in perceived social support as assessed by the Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Baseline, post intervention (8 weeks after baseline)
measure: Change in post stroke depression as assessed by the Patient Health Questionnaire-9 score (PHQ-9)
timeFrame: Baseline, post intervention (8 weeks after baseline)
measure: Change in anxiety as assessed by the Generalized Anxiety Disorder-7 score
timeFrame: Baseline, post intervention (8 weeks after baseline)
measure: Change in loneliness as assessed by the UCLA loneliness scale scores
timeFrame: Baseline, post intervention (8 weeks after baseline)
measure: Change in caregiver burden as assessed by the Zarit Burden Interview (ZBI)
timeFrame: Baseline, post intervention (8 weeks after baseline)
measure: Change in self efficacy ( ability to perform tasks or behaviors) as assessed by the PROMIS General Self-efficacy Form
timeFrame: Baseline, post intervention (8 weeks after baseline)
measure: Change in emotional support as assessed by the NIH Emotional Support Form
timeFrame: Baseline, post intervention (8 weeks after baseline)
measure: Change in instrumental support as assessed by the PROMIS Short Form v2.0
timeFrame: Baseline, post intervention (8 weeks after baseline)
measure: Change in ability to recover form stress as measured by the Brief Resilience Scale
timeFrame: Baseline, post intervention (8 weeks after baseline)
measure: Change in the amount that pain interferes with daily life as assessed by the PROMIS Short Form Pain Interference v 1.0 8a
timeFrame: Baseline, post intervention (8 weeks after baseline)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jennifer Beauchamp, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: