Occupational TherapyiSMARTNCT04743037
Interactive Self-Management Augmented by Rehabilitation Technologies
A study testing iSMART in people with Occupational Therapy and Epidemiology, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occupational Therapy, Epidemiology, Neurologic Disorder
- What is being tested?
- iSMART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic or hemorrhagic stroke (NIHSS scores ≤13)
- aged ≥18
- English-speaking
- ≥3 months post-stroke
- identified as having ≥1 chronic condition
- mobile phone ownership.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Feasibility of Mobile Self-Management Intervention for Mild Stroke
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.
Read more
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.
Read the detailed description
In this study, the investigators will take 30 stroke survivors and have them participate in a 3-month study consisting of screening, assessments, goal setting, health coaching, EMA surveys, and feedback on how to improve the study for a future expanded study.
After the research team consents and enrolls participants, participants will be randomized and complete screening, assessment, and training on the video conferencing system, training on the Status/Post and SMS. The screening measures and assessments that will be performed are: Participation Strategies Self-Efficacy Scale, PROMIS Self Efficancy, Stroke Impact Scale, Activity Card Sort, Reintegration to Normal Living Index, PHQ-9, PROMIS 29+2, Light House Test, Boston Naming Test, and Short Blessed Test form are all assessments that will be performed online through REDCap via a secure link over the phone or email. The last three tests are screening instruments. The investigators can perform all assessments online through REDCap via a secure link over the phone or email. All data collected will be directly entered into REDCap. Participants will receive an iPod touch if they do not have an iPhone which will be mailed to them to use for the next 14 days. Participants will complete the EMA assessment prototype 5x/day for 14 days via the Status/post-application. Goals will also be set that the participant would like to achieve. If participants do not have a phone or mobile device capable of using the video conferencing system and SMS, the investigators will mail them an iPad to use for the study duration.
The 15 MyIPASS 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, MyIPASS 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.
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 MyIPASS intervention as the intervention group.
A pre-selected time will be scheduled for the participant to complete their post-assessments, and complete an interview after the 12 weeks via the phone. The assessments will be administered the same as they were in the pre-test, given a link over the phone or email to a secure RedCap site which will include the following assessments: Client Satisfaction Questionnaire (CSQ), Healing Encounters \& Attitudes Lists - Patient-Provider Connection (HEAL-PPC), PROMIS Self Efficancy, Stroke Impact Scale, Activity Card Sort, Reintegration to Normal Living Index, PHQ-9, PROMIS 29+2, Acceptability of Implementation Measure (AIM), Appropriateness of Implementation Measure (IAM), and Feasibility of Implementation Measures after the intervention. The investigators will ask them to mail the iPod back to the lab when they are finished with their 14-day surveys with a prepaid envelope. If participants used an iPad, they will return it to the lab via mail in a prepaid envelope.
At the conclusion of the trial, the investigators will ask the 30 stroke survivors, the investigators will conduct the feedback questions during the follow-up phone appointment. All interviews will be facilitated by a moderator. Moderators will be trained with the interview guide and Computer Usage Questionnaire. Sessions will be audio/video recorded to allow for transcription and analysis. Participants may share as much as they would like or feel comfortable.
Data from participants will be collected from screening measures, assessments, and the SMS prototype. Please refer to the attachment for knowing what coded data will be extracted from the SMS dashboard. During the data collection process, members of the research team may photograph the participant doing a variety of tasks if given permission.
- Conditions
- Occupational Therapy, Epidemiology, Neurologic Disorder
- Being tested
- iSMART
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSMARTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: iSMART |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-treatment (week 0) and Post-treatment (week 12)
Secondary outcomes (5)
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.
Measured: Pre-treatment (week 0) and Post-treatment (week 12)
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.
Measured: Pre-treatment (week 0) and Post-treatment (week 12)
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.
Measured: Pre-treatment (week 0) and Post-treatment (week 12)
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.
Measured: Pre-treatment (week 0) and Post-treatment (week 12)
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)
Measured: Course of Study 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start1 Sep 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occupational TherapyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Responsible party
- Sponsor
- Investigators
- Wing Wong, PhD, Principal investigator, Washington University OT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743037
- Sponsor's protocol ID
- 202004137
- Acronym
- iSMART
- Status last verified
- Aug 2021
- First submitted
- 2 Feb 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Publications
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.
PubMed 38373029
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Mobile Self-Management Intervention for Mild Stroke
- ClinicalTrials.gov ID
- NCT04743037
- Acronym / sponsor ID
- iSMART / 202004137
- Conditions
- Occupational Therapy, Epidemiology, Neurologic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, the investigators will take 30 stroke survivors and have them participate in a 3-month study consisting of screening, assessments, goal setting, health coaching, EMA surveys, and feedback on how to improve the study for a future expanded study.
After the research team consents and enrolls participants, participants will be randomized and complete screening, assessment, and training on the video conferencing system, training on the Status/Post and SMS. The screening measures and assessments that will be performed are: Participation Strategies Self-Efficacy Scale, PROMIS Self Efficancy, Stroke Impact Scale, Activity Card Sort, Reintegration to Normal Living Index, PHQ-9, PROMIS 29+2, Light House Test, Boston Naming Test, and Short Blessed Test form are all assessments that will be performed online through REDCap via a secure link over the phone or email. The last three tests are screening instruments. The investigators can perform all assessments online through REDCap via a secure link over the phone or email. All data collected will be directly entered into REDCap. Participants will receive an iPod touch if they do not have an iPhone which will be mailed to them to use for the next 14 days. Participants will complete the EMA assessment prototype 5x/day for 14 days via the Status/post-application. Goals will also be set that the participant would like to achieve. If participants do not have a phone or mobile device capable of using the video conferencing system and SMS, the investigators will mail them an iPad to use for the study duration.
The 15 MyIPASS 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, MyIPASS 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.
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 MyIPASS intervention as the intervention group.
A pre-selected time will be scheduled for the participant to complete their post-assessments, and complete an interview after the 12 weeks via the phone. The assessments will be administered the same as they were in the pre-test, given a link over the phone or email to a secure RedCap site which will include the following assessments: Client Satisfaction Questionnaire (CSQ), Healing Encounters \& Attitudes Lists - Patient-Provider Connection (HEAL-PPC), PROMIS Self Efficancy, Stroke Impact Scale, Activity Card Sort, Reintegration to Normal Living Index, PHQ-9, PROMIS 29+2, Acceptability of Implementation Measure (AIM), Appropriateness of Implementation Measure (IAM), and Feasibility of Implementation Measures after the intervention. The investigators will ask them to mail the iPod back to the lab when they are finished with their 14-day surveys with a prepaid envelope. If participants used an iPad, they will return it to the lab via mail in a prepaid envelope.
At the conclusion of the trial, the investigators will ask the 30 stroke survivors, the investigators will conduct the feedback questions during the follow-up phone appointment. All interviews will be facilitated by a moderator. Moderators will be trained with the interview guide and Computer Usage Questionnaire. Sessions will be audio/video recorded to allow for transcription and analysis. Participants may share as much as they would like or feel comfortable.
Data from participants will be collected from screening measures, assessments, and the SMS prototype. Please refer to the attachment for knowing what coded data will be extracted from the SMS dashboard. During the data collection process, members of the research team may photograph the participant doing a variety of tasks if given permission.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: iSMARTThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ischemic or hemorrhagic stroke (NIHSS scores ≤13)
- aged ≥18
- English-speaking
- ≥3 months post-stroke
- identified as having ≥1 chronic condition
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iSMARTThis 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. | Behavioural | iSMART |
Primary outcome
Acceptability: Acceptability of Intervention Measure (AIM)
Time frame: Post-treatment (week 12)
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.
Appropriateness: Intervention Appropriateness Measure (IAM)
Time frame: Post-treatment (week 12)
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.
Feasibility: Feasibility of Intervention Measure (FIM)
Time frame: Post-treatment (week 12)
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.
Satisfaction: Client Satisfaction Questionnaire
Time frame: Post-treatment (week 12)
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.
Participation Self-Efficacy: Participation Strategies Self-Efficacy Scale
Time frame: Pre-treatment (week 0) and Post-treatment (week 12
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.
General Self-Efficacy: PROMIS-Self-Efficacy Short Forms
Time frame: Pre-treatment (week 0) and Post-treatment (week 12)
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.
5 secondary outcomes
Functioning: Stroke Impact Scale
Time frame: Pre-treatment (week 0) and Post-treatment (week 12)
Activity: Activity Card Sort
Time frame: Pre-treatment (week 0) and Post-treatment (week 12)
Participation: Reintegration to Normal Living Index
Time frame: Pre-treatment (week 0) and Post-treatment (week 12)
Quality of Life: PROMIS® 29+2 Profile v2.1 (PROPr)
Time frame: Pre-treatment (week 0) and Post-treatment (week 12)
Non-specific treatment factors: Healing Encounters & Attitudes Lists
Time frame: Course of Study 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Derived from this study: PubMed 38373029Li 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.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
Related trials for Occupational Therapy
Recruiting
Effectiveness of Virtual Reality in Improving Upper Limb Function in Critically Ill Patients
Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Critical Illness
Recruiting
Structured Sensory-Based Occupational Therapy in Children With Autism
Autism Spectrum Disorder
Recruiting
Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers
Bladder Carcinoma, Genitourinary System Neoplasm
Not yet recruiting
Effect of Occupational Therapy on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness
Schizophenia Disorder, Severe Mental Illness
Not yet recruiting
Supplemental Mobility
Aging, Functional Recovery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wing Wong, PhD principal investigator
Washington University OT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iSMART in people with Occupational Therapy and Epidemiology, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability: Acceptability of Intervention Measure (AIM) (time frame: Post-treatment (week 12)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04743037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.