R-D1D – A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Control Trial (Preprint)

2021 ◽  
Author(s):  
Michelle Litchman ◽  
Bethany M. Kwan ◽  
Linda Zittleman ◽  
Juliana Simonetti ◽  
Eli Iacob ◽  
...  
Keyword(s):  
Rural Communities ◽  
Diabetes Care ◽  
Randomized Control Trial ◽  
Rural Populations ◽  
Diabetes Distress ◽  
Patient Level ◽  
Culturally Adapted ◽  
Test Kit ◽  
Patient Reported ◽  
Randomized Control

BACKGROUND Diabetes self-management education and support (DSMES) is a crucial component of diabetes care associated with improved clinical, psychosocial, and behavioral outcomes. The American Association of Diabetes Care and Education Specialists, the American Diabetes Association, and the American Academy of Family Physicians all recommend DSMES,1 yet accessing linguistically and culturally appropriate DSMES is challenging in rural areas. The Diabetes One-Day (D1D) program is an established DSMES group intervention that has not been adapted or evaluated in rural communities. OBJECTIVE The specific aims are: 1) adapt the existing D1D program for use in rural communities, called rural D1D (R-D1D) and 2) Conduct a patient-level randomized control trial to examine effects of R-D1D and standard patient education, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. METHODS This is a protocol for a pilot type II hybrid implementation-effectiveness trial of a culturally adapted virtual DSMES program for rural populations, R-D1D. We will use Boot Camp Translation, a process grounded in the principles of community-based participatory research, to adapt an existing DSMES program for rural populations, in both English and Spanish. Participants at two rural primary care clinics (4 cohorts of N=16 plus care partners, 2 in English and 2 in Spanish) will be randomized to the intervention or standard education control. The evaluation is guided by the RE-AIM framework. Patient-level effectiveness outcomes (A1c, diabetes distress and diabetes self-care behaviors) will be assessed using patient-reported outcomes measures and a home A1c test kit. Practice- and patient-level acceptability and feasibility will be assessed using surveys and interviews. RESULTS This study is supported by the National Institute of Nursing. Study procedures were approved, and adaptation processes have been completed. Recruitment and enrollment started in July 2021. CONCLUSIONS To our knowledge, this will be the first study to evaluate both effectiveness and implementation outcomes for virtually delivered DSMES culturally adapted for rural populations. This research has implications for delivery to other rural locations where access to specialty diabetes care is limited. CLINICALTRIAL ClinicalTrials.gov NCT04600622; https://clinicaltrials.gov/ct2/show/NCT04600622

The State of Prophylactic Mesh Augmentation

2018 ◽  
Vol 84 (1) ◽  
pp. 99-108 ◽  
Author(s):  
Michael A. Lanni ◽  
Michael G. Tecce ◽  
Valeriy Shubinets ◽  
Michael N. Mirzabeigi ◽  
John P. Fischer
Keyword(s):  
Randomized Control Trial ◽  
Large Scale ◽  
Surgical Techniques ◽  
The United States ◽  
Cost Utility ◽  
Prophylactic Mesh ◽  
Mesh Placement ◽  
Mesh Augmentation ◽  
Patient Reported ◽  
Randomized Control

Prophylactic mesh augmentation (PMA) is the implantation of mesh during closure of an index laparotomy to decrease a patient's risk for developing incisional hernia (IH). The current body of evidence lacks refined guidelines for patient selection, mesh placement, and material choice. The purpose of this study is to summarize the literature and identify areas of research needed to foster responsible and appropriate use of PMA as an emerging technique. We conducted a comprehensive review of Scopus, Cochrane, PubMed, and clinicaltrials.gov for articles and trials related to using PMA for IH risk reduction. We further supplemented our review by including select papers on patient-reported outcomes, cost utility, risk modeling, surgical techniques, and available materials highly relevant to PMA. Five-hundred-fifty-one unique articles and 357 trials were reviewed. Multiple studies note a significant decrease in IH incidence with PMA compared with primary suture-only–based closure. No multicenter randomized control trial has been conducted in the United States, and only two such trials are currently active worldwide. Evidence exists supporting the use of PMA, with practical cost utility and models for selecting high-risk patients, but standard PMA guidelines are lacking. Although Europe has progressed with this technique, widespread adoption of PMA requires large-scale pragmatic randomized control trial research, strong evidence-based guidelines, current procedural terminology coding, and resolution of several barriers.

scholarly journals R-D1D – A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Control Trial (Preprint)

10.2196/34255 ◽  
2021 ◽  
Author(s):  
Michelle Litchman ◽  
Bethany M. Kwan ◽  
Linda Zittleman ◽  
Juliana Simonetti ◽  
Eli Iacob ◽  
...  
Keyword(s):  
Randomized Control Trial ◽  
Rural Populations ◽  
Diabetes Intervention ◽  
Randomized Control

scholarly journals 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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Gena R. 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 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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