Neurologic Disorder Clinical Trial
— iSMARTOfficial title:
Feasibility of Mobile Self-Management Intervention for Mild Stroke
Verified date | August 2021 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - ischemic or hemorrhagic stroke (NIHSS scores =13) - aged =18 - English-speaking - =3 months post-stroke - identified as having =1 chronic condition - mobile phone ownership. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Shirley Ryan AbilityLab |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acceptability: Acceptability of Intervention Measure (AIM) | A 4-item short-form to assess acceptability of an intervention's implementation (Weiner et al., 2017). High acceptability is defined as the score 16 or higher out of 20 on the AIM. | Post-treatment (week 12) | |
Primary | Appropriateness: Intervention Appropriateness Measure (IAM) | A 4-item short-form to assess appropriateness of an intervention's implementation (Weiner et al., 2017). High appropriateness is defined as the score 16 or higher out of 20 on the IAM. | Post-treatment (week 12) | |
Primary | Feasibility: Feasibility of Intervention Measure (FIM) | A 4-item short-form to assess feasibility of an intervention's implementation (Weiner et al., 2017). High feasibility is defined as the score 16 or higher out of 20 on the FIM. | Post-treatment (week 12) | |
Primary | Satisfaction: Client Satisfaction Questionnaire | An 8-item measure to assess the extent of satisfaction with services and met needs (Attkisson & Greenfield, 2004). High acceptability is defined as the score 24 or higher out of 32 on the Client Satisfaction Questionnaire. | Post-treatment (week 12) | |
Primary | Participation Self-Efficacy: Participation Strategies Self-Efficacy Scale | A 35-item measure to assess the self-efficacy in managing home, work, community participation; communication; & advocating resources (D. Lee, Fogg, Baum, Wolf, & Hammel, 2018). Pre- and post-treatment change score is used to indicate the magnitude change of this construct after intervention. Cohen's d effect size of change >.20 to indicate a meaningful change. | Pre-treatment (week 0) and Post-treatment (week 12 | |
Primary | General Self-Efficacy: PROMIS-Self-Efficacy Short Forms | 5 short forms to assess self-efficacy for managing: (1) daily activities, (2) medications and treatment, (3) symptoms, (4) emotions, and (5) social interactions. Each form is consisted of 4 items (Gruber-Baldini, Velozo, Romero, & Shulman, 2017). Pre- and post-treatment change score is used to indicate the magnitude change of this construct after intervention. Cohen's d effect size of change >.20 to indicate a meaningful change. | Pre-treatment (week 0) and Post-treatment (week 12) | |
Secondary | Functioning: Stroke Impact Scale | A 59-item self-reported scale to measure 8 domains: strength, hand function, ADLs, mobility, communication, emotion, cognition, and participation (Duncan, Bode, Lai, & Perera, 2003). Pre- and post-treatment change score is used to indicate the magnitude change of this construct after intervention. Cohen's d effect size of change >.20 to indicate a meaningful change. | Pre-treatment (week 0) and Post-treatment (week 12) | |
Secondary | Activity: Activity Card Sort | A 89-item measure to assess the engagement in social, instrumental, & leisure activities (C. M. Baum & Edwards, 2001). Pre- and post-treatment change score is used to indicate the magnitude change of this construct after intervention. Cohen's d effect size of change >.20 to indicate a meaningful change. | Pre-treatment (week 0) and Post-treatment (week 12) | |
Secondary | Participation: Reintegration to Normal Living Index | An 11-item measure to assess the extent of integration into normal activities after illness (Bourget, Deblock-Bellamy, Blanchette, & Batcho, 2018). Pre- and post-treatment change score is used to indicate the magnitude change of this construct after intervention. Cohen's d effect size of change >.20 to indicate a meaningful change. | Pre-treatment (week 0) and Post-treatment (week 12) | |
Secondary | Quality of Life: PROMIS® 29+2 Profile v2.1 (PROPr) | PROPr is used to calculate a preference score. This preference-based score is estimated based on multiple health domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, cognitive abilities), which provides a single summary score for overall health that can be used in comparisons across groups, treatment options in decision-making and cost-effectiveness analyses. We will also use this instrument throughout individual coaching sessions to guide the participant to identify the key problem area for self-management (Dewitt et al., 2018). Pre- and post-treatment change score is used to indicate the magnitude change of this construct after intervention. Cohen's d effect size of change >.20 to indicate a meaningful change. | Pre-treatment (week 0) and Post-treatment (week 12) | |
Secondary | Non-specific treatment factors: Healing Encounters & Attitudes Lists | : Measuring nonspecific factors in treatment, including: (1) patient-provider connection (PPC), (2) healthcare environment (HCE), (3) treatment expectancy (TE), (4) positive outlook, and (5) spirituality (Greco et al., 2016) | Course of Study 12 weeks |
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