Interactive Self-Management Augmented by Rehabilitation Technologies

NCT04743037 | Completed

• 1 other identifier: 202004137
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Occupational Therapy; Epidemiology; Neurologic Disorder

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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

• 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 Outcomes (5)

• Functioning: Stroke Impact Scale

  Pre-treatment (week 0) and Post-treatment (week 12)

• Activity: Activity Card Sort

  Pre-treatment (week 0) and Post-treatment (week 12)

• Participation: Reintegration to Normal Living Index

  Pre-treatment (week 0) and Post-treatment (week 12)

• Quality of Life: PROMIS® 29+2 Profile v2.1 (PROPr)

  Pre-treatment (week 0) and Post-treatment (week 12)

• Non-specific treatment factors: Healing Encounters & Attitudes Lists

  Course of Study 12 weeks

Study Arms (2)

Standard of Care (SOC)

NO INTERVENTION

The 15 attentional control group stroke survivors will receive phone calls over the 12-week intervention checking in with them on how they are doing in their everyday life. They will also receive stroke education materials, but they will not receive the same iSMART intervention as the intervention group.

iSMART

EXPERIMENTAL

The 15 iSMART participants will engage in video conference sessions between the pre and post visits. A health coach will collaboratively work with the participant to practice treatment strategies and set goals in weekly individual sections. In addition, all participants will engage in weekly group sessions with a health coach in order to learn and practice specific self-management skills and strategies in a group context. In addition, iSMART entails using an interactive SMS to provide ongoing support and self-monitoring of behavior change goals. The SMS is programmed to "touch" participants daily; the SMS system prompts participants to report their daily activities and progress in achieving goals via "check-in" messages and sends immediate, tailored feedback about their progress. If a participant is making progress toward their goal, the SMS system will suggest a change to the participant's goal between visits.

Behavioral: iSMART

Interventions

iSMART BEHAVIORAL

This patient-centered and participation-focused self-management intervention will help individuals develop strategies to manage chronic conditions and support their full participation in meaningful life activities.

iSMART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Shirley Ryan AbilityLab: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Li Z, Lei Y, Bui Q, DePaul O, Nicol GE, Mohr DC, Lee SI, Fong MWM, Metts CL, Tomazin SE, Wong AWK. A Digital Intervention to Promote Self-Management Self-Efficacy Among Community-Dwelling Individuals With Stroke: Pilot Randomized Controlled Trial. JMIR Rehabil Assist Technol. 2024 Feb 19;11:e50863. doi: 10.2196/50863.

  PMID: 38373029 DERIVED

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Wing Wong, PhD

  Washington University OT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 8, 2021
• Study Start: September 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)