Interactive Self-Management Augmented by Rehabilitation Technologies

Completed · Not applicable

Conditions studied: Occupational Therapy, Epidemiology, Neurologic Disorder

In brief

Background: Stroke is a leading cause of long-term disability in the US. Mild stroke comprises half of stroke hospital admissions, but most people with mild stroke receive no rehabilitation services. Mild stroke is often the manifestation of uncontrolled chronic conditions (e.g. hypertension, diabetes), and people with mild stroke also experience ongoing chronic symptoms (e.g. depression, fatigue) that may impact their daily activities. An inability to manage chronic conditions and symptoms may lead to decreased participation in pre-stroke roles and activities, which may increase the chance of sustaining a second stroke. An effective intervention to manage chronic conditions and support participation is self-management. A meta-review of 13 systematic reviews demonstrated that self-management interventions significantly improve stroke survivors' daily activities, independence, and mortality. National research agendas from the Department of Health and Human Services (HHS) and Institute of Medicine (IOM) include self-management as one key goal of a strategic framework, aligning with the AOTF Research Priorities, for promoting (1) health behaviors to prevent and manage chronic conditions. Our preliminary studies indicate that mobile health (mHealth), defined as the delivery of healthcare services via mobile devices, can be used to precisely monitor participation in daily activities and mood and is acceptable in stroke survivors. Our meta-analysis indicates that digital self-management interventions are more effective in improving depression, fatigue, anxiety, and self-efficacy in people with neurologic disorders in comparison to non-digital self-management interventions. These studies support the AOTF Research Priorities that include (2) use of technology to support home and community activities, and (3) emotional influences. Objectives: The investigators will harness mHealth technology for a self-management program. Our intervention is a mobile phone intervention called iOTA, which builds on extensive work by my mHealth mentor and colleagues in health behavior research. The investigators will use a formal implementation science framework to adapt and test the iOTA intervention. The investigators will cohere an adaptation framework by soliciting stakeholder input to adapt the iOTA from Improving Participation after Stroke Self-Management (IPASS), an evidence-based intervention that targets self-management of chronic conditions and increased community participation in stroke survivors. Methods: The investigators will use a two-step approach, including a rigorous treatment adaptation and a Phase I feasibility trial. Our first step is to adapt the intervention with input from all relevant stakeholder levels. Our second step is to use a pre-post, non-randomized study design to test the adapted iOTA. Ten community-dwelling people with mild stroke will participate in the iOTA for 3 months. The iOTA incorporates daily short message service (SMS) text messages to supplement monthly in-person health coaching and weekly videoconference sessions. The investigators will include an occupational therapist (OT) as a health coach to teach individuals to incorporate self-management strategies into their daily routines to support participation in meaningful activities. Expected Outcome: This mHealth treatment development study will increase the reach and access of IPASS-a patient-centered, participation-focused self-management program for stroke survivors. The iOTA created will not only maximize our potential for the future randomized controlled trial (RCT) but also lay the groundwork for future funding mechanisms.

Key facts

Study ID

NCT04743037

Run by

Washington University School of Medicine

People needed

24

Starts

2020-09-01

Expected to finish

2021-06-30

Last updated by the study team

2021-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ischemic or hemorrhagic stroke (NIHSS scores ≤13)
• aged ≥18
• English-speaking
• ≥3 months post-stroke
• identified as having ≥1 chronic condition
• mobile phone ownership.

You may not qualify if…

• previous neurologic or psychiatric disorder (e.g. dementia or schizophrenia)
• Short Blessed Test score ≥9 (indicating severe cognitive impairment) (Katzman et al., 1983)
• history of functional problems (pre-morbid modified Ranking Scale score ≥2) regardless of prior stroke
• severe aphasia (Boston Naming Test ≤10) (Kaplan, Goodglass, \& Weintraub, 2001) or NIH Stroke Scale Aphasia subscale score ≥2.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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