A randomized controlled trial of self-management for people with epilepsy and a history of negative health events (SMART) targeting rural and underserved people with epilepsy: a methodologic report

Abstract Background Many people living with epilepsy (PLWE) reside in rural communities, and epilepsy self-management may help address some of the gaps in epilepsy care for these communities. A prior randomized control trial of a remotely delivered, Web-based group format 12-week self-management program (SMART) conducted in Northeast Ohio, a primarily urban and suburban community, demonstrated improved outcomes in negative health events such as depression symptoms and quality of life. However, there is a paucity of research addressing the needs of PLWE in rural settings. Methods The present study leverages collaboration between investigators from 2 mid-western US states (Ohio and Iowa) to replicate testing of the SMART intervention and prioritize delivery to PLWE in rural and semi-rural communities. In phase 1, investigators will refine the SMART program using input from community stakeholders. A Community Advisory Board will then be convened to help identify barriers to trial implementation and strategies to overcome barriers. In phase 2, the investigators will conduct a 6-month prospective randomized control trial of the SMART program compared to 6-month waitlist controls, with the primary outcome being changes in negative health events defined as seizure, self-harm attempt, emergency department visit, or hospitalization. Additional outcomes of interest include quality of life and physical and mental health functioning. The study will also assess process measures of program adopters and system end-users to inform future outreach, education, and self-management strategies for PLWE. Discussion The method of this study employs lived experience of PLWE and those who provide care for PLWE in rural and underserved populations to refine a remotely delivered Web-based self-management program, to improve recruitment and retention, and to deliver the intervention. Pragmatic outcomes important to PLWE, payers, and policymakers will be assessed. This study will provide valuable insights on implementing future successful self-management programs. Trial registration ClinicalTrials.gov NCT04705441. Registered on January 12, 2021

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Self-management for people with epilepsy and a history of negative health events (SMART) targeting rural and underserved people with epilepsy: A methodologic report

10.21203/rs.3.rs-401711/v1 ◽

2021 ◽

Author(s):

Gena Ghearing ◽

Farren Briggs ◽

Kristin Cassidy ◽

Michael Privitera ◽

Carol Blixen ◽

...

Keyword(s):

Quality Of Life ◽

Rural Communities ◽

Randomized Control Trial ◽

Management Program ◽

Community Advisory Board ◽

Self Management ◽

Web Based ◽

Health Events ◽

Randomized Control

Abstract Background: Many people living with epilepsy (PLWE) reside in rural communities, and epilepsy self-management may help address some of the gaps in epilepsy care for these communities. A prior randomized control trial of a remotely delivered, web-based group format 12-week self-management program (SMART) conducted in Northeast Ohio, a primarily urban and suburban community, demonstrated improved outcomes in negative health events such as depression symptoms and quality of life. However, there is a paucity of research addressing the needs of PLWE in rural settings.Methods: The present study leverages collaboration between investigators from 2 mid-western U.S. states (Ohio and Iowa) to replicate testing of the SMART intervention and prioritize delivery to PLWE in rural and semi-rural communities. In Phase 1, investigators will refine the SMART program using input from community stakeholder. A community advisory board will then be convened to help identify barriers to trial implementation and strategies to overcome barriers. In Phase 2, the investigators will conduct a 6-month prospective randomized control trial of the SMART program compared to 6-month wait-list controls, with the primary outcome being changes in negative health events defined as seizure, self-harm attempt, emergency department visit, or hospitalization. Additional outcomes of interest include quality of life and physical and mental health functioning. The study will also assess process measures of program adopters and system end-users to inform future outreach, education, and self-management strategies for PLWE.Discussion The method of this study employs lived experience of PLWE and those who provide care for PLWE in rural and underserved populations to refine a remotely delivered web-based self-management program, to improve recruitment and retention, and to deliver the intervention. Pragmatic outcomes important to PLWE, payers, and policymakers, will be assessed. This study will provide valuable insights on implementing future successful self-management programs.Trial registration: The study has been registered at ClinicalTrials.gov (NCT04705441) on January 12, 2021.

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Results on health-related quality of life and functionality of a patient-centered self-management program in hospitalized COPD: a randomized control trial

Disability and Rehabilitation ◽

10.1080/09638288.2019.1609099 ◽

2019 ◽

Vol 42 (25) ◽

pp. 3687-3695 ◽

Cited By ~ 1

Author(s):

Laura Lopez-Lopez ◽

Marie Carmen Valenza ◽

Janet Rodriguez-Torres ◽

Irene Torres-Sanchez ◽

Maria Granados-Santiago ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Control Trial ◽

Management Program ◽

Self Management ◽

Health Related Quality ◽

Patient Centered ◽

Related Quality ◽

Health Related ◽

Randomized Control

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Using tele-health to enhance motivation, leisure time physical activity, and quality of life in adults with spinal cord injury: A self-determination theory-based pilot randomized control trial

Psychology of Sport and Exercise ◽

10.1016/j.psychsport.2019.03.008 ◽

2019 ◽

Vol 43 ◽

pp. 243-252 ◽

Cited By ~ 8

Author(s):

K. Chemtob ◽

M. Rocchi ◽

K. Arbour-Nicitopoulos ◽

D. Kairy ◽

B. Fillion ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Control Trial ◽

Leisure Time ◽

Leisure Time Physical Activity ◽

Self Determination Theory ◽

Self Determination ◽

Cord Injury ◽

Randomized Control ◽

Pilot Randomized Control Trial

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Differences in quality of life and patient satisfaction between complete denture occlusion schemes: A parallel randomized control trial

Journal of Prosthetic Dentistry ◽

10.1016/j.prosdent.2021.07.015 ◽

2021 ◽

Author(s):

Ramya Srinivasan ◽

Naveen Gopi Chander ◽

Jetti Ramesh Reddy ◽

Muthukumar Balasubramanian

Keyword(s):

Quality Of Life ◽

Patient Satisfaction ◽

Randomized Control Trial ◽

Complete Denture ◽

Randomized Control

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Intergenerational volunteering and quality of life: mixed methods evaluation of a randomized control trial involving persons with mild to moderate dementia

Quality of Life Research ◽

10.1007/s11136-010-9837-8 ◽

2011 ◽

Vol 20 (7) ◽

pp. 987-995 ◽

Cited By ~ 24

Author(s):

Daniel R. George

Keyword(s):

Quality Of Life ◽

Mixed Methods ◽

Randomized Control Trial ◽

Mixed Methods Evaluation ◽

Moderate Dementia ◽

Randomized Control

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Supporting Self-Management and Quality of Life in Bipolar Disorder with the Beta PolarUs App: Protocol for a Mixed-Methods Study (Preprint)

10.2196/preprints.36213 ◽

2022 ◽

Author(s):

Erin E Michalak ◽

Steven J Barnes ◽

Emma Morton ◽

Heather O'Brien ◽

Greg Murray ◽

...

Keyword(s):

Quality Of Life ◽

Mixed Methods ◽

Management Strategies ◽

Community Based Participatory Research ◽

Self Management ◽

Community Based ◽

Self Monitoring ◽

Web Based ◽

Beta Version

BACKGROUND Quality of life (QoL) is increasingly recognised as a key outcome of self-management interventions for bipolar disorder (BD). Mobile phone applications (apps) can increase access to evidence-based self-management strategies and provide real-time support. However, while individuals with lived experience desire support with monitoring and improving broader health domains, existing BD apps largely target mood symptoms only. Further, evidence from the broader mHealth literature has shown that the desires and goals of end-users are not adequately taken into account during app development, and as a result engagement with mental health apps is suboptimal. To capitalise on the potential of apps to optimise wellness in BD, there is a need for interventions developed in consultation with real-world users that are designed to support QoL self-monitoring and self-management. Objective: This mixed methods pilot study is designed to evaluate the beta version of the newly developed PolarUs app, which aims to support QoL self-monitoring and self-management in people with BD. Developed using a community-based participatory research framework, the PolarUs app builds on the web-based adaptation of a BD-specific QoL self-assessment measure, and integrates material from a web-based portal providing information on evidence-informed self-management strategies in BD. OBJECTIVE The primary objectives of this project are to: (1) evaluate PolarUs app feasibility (via behavioral usage metrics); (2) evaluate PolarUs impact (via the Brief Quality of Life in Bipolar Disorders, QoL.BD scale, our primary outcomes measure); and (3) explore engagement with the PolarUs app (via both quantitative and qualitative methods). METHODS Study participants will be North American residents (N=150) aged 18-65 years with a DSM-5 diagnosis of BD-I, BD-II or BD not otherwise specified (NOS) as assessed by a structured diagnostic interview. An embedded mixed-methods research design will be adopted; qualitative interviews with a purposefully selected sub-sample (~n=30) of participants will be conducted to explore in more depth feasibility, impact and engagement with the PolarUs app over the 12-week study period. RESULTS At the time of publication of this protocol, the development of the beta version of the PolarUs app is complete. Participant enrollment is expected to begin in February 2022. Data collection is expected to be completed by December 2022. CONCLUSIONS Beyond contributing knowledge on the feasibility and impacts of a novel app to support QoL and self-management in BD, this study is also expected to provide new knowledge on engagement with mHealth apps. Furthermore, it is expected to function as a case study of successful co-design between individuals living with BD, clinicians who specialise in the treatment of BD, and BD researchers, providing a template for future use of community-based participatory research frameworks in mHealth intervention development. Results will be used to further refine the PolarUs app and inform the design of a larger clinical trial.

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2294 Do patient comorbidities impact the effectiveness of a COPD self-management program?

Journal of Clinical and Translational Science ◽

10.1017/cts.2018.163 ◽

2018 ◽

Vol 2 (S1) ◽

pp. 41-41

Author(s):

Emilia Galli Thurber ◽

Hanan Aboumatar

Keyword(s):

Quality Of Life ◽

Patient Outcomes ◽

The United States ◽

Management Program ◽

Emergency Department Visits ◽

The Self ◽

Self Management ◽

Management Intervention ◽

Comorbidity Burden

OBJECTIVES/SPECIFIC AIMS: Chronic obstructive pulmonary disease (COPD) is a leading cause of both hospitalizations and readmissions in the United States, and about 1 in 5 hospitalized patients with COPD will be readmitted within 30 days. COPD-focused self-management programs are frequently used to help patients better manage their symptoms and prevent hospitalization. However, while the majority of patients with COPD have at least one comorbidity, most trials of COPD self-management programs either excluded patients with significant comorbidities or did not analyze the impact of comorbidities on patient outcomes. Using data from the BREATHE trial of a COPD self-management program, this study aims to determine if patient post-intervention outcomes differ based on the intensity and type of patient comorbidities. METHODS/STUDY POPULATION: In total, 240 patients hospitalized for COPD were randomly assigned to either a comprehensive self-management intervention or usual transitional care. Primary outcomes for this trial were the number of COPD-related hospitalizations and emergency department visits at 6 months and changes in COPD-specific quality of life. To determine whether patient comorbidities modify the effect of the self-management intervention on readmission and quality of life outcomes, we will compare patient outcomes across groups stratified by comorbidity burden (Charlson Comorbidity Index) and type (baseline diagnosis of congestive heart failure, diabetes, and depression). In addition, we will use regression analysis with interaction terms to test for interaction between comorbidity burden/type and intervention assignment. RESULTS/ANTICIPATED RESULTS: We hypothesize that the effect of the self-management intervention will differ in patients with greater comorbidity burden due to competing medical demands for patients with multimorbidity. DISCUSSION/SIGNIFICANCE OF IMPACT: The results of this study will help clinicians better target disease-specific self-management programs to the groups of patients with COPD who are likely to receive the greatest benefit from this type of intervention.

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