Resilient, Empowered, Active Living-Telehealth (REAL-T) for Diabetes, Autoimmune

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
USC Center for Health Professionals, Los Angeles, CA
Diabetes, Autoimmune+1 More
Resilient, Empowered, Active Living-Telehealth (REAL-T) - Behavioral
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a lifestyle-based telehealth intervention can help improve glycemic control and psychosocial outcomes for individuals with type 2 diabetes.

See full description

Eligible Conditions

  • Diabetes, Autoimmune

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Resilient, Empowered, Active Living-Telehealth (REAL-T) will improve 1 primary outcome, 15 secondary outcomes, and 1 other outcome in patients with Diabetes, Autoimmune. Measurement will happen over the course of Baseline.

6 months
Telehealth Satisfaction
Baseline
Background Information
Month 12
Change in cost to payor
Month 12
Change in automaticity of behavior (testing blood sugar), using the "Self-Report Behavioural Automaticity Index" (SRBAI)
Change in autonomy of taking insulin and/or checking blood sugar, using the "Treatment Self-Regulation Questionnaire" (TSRQ)
Change in cost to patients
Change in global diabetes self-management, using the "Diabetes Self-Management Questionnaire-Revised" (DSMQ-R).
Change in glycemic control, using Glycated Hemoglobin (HbA1C)
Change in medication adherence, using the "3-item adherence self-report scale" questionnaire
Change in self management of blood glucose, using the # of blood glucose checks
Change in self-efficacy for performing diabetes self-management, using the "Diabetes Empowerment Scale - Short Form" (DES-SF)
Month 12
Change in diabetes-related emotional distress, using the "Diabetes Distress Scale" (DDS)
Change in diabetes-related quality of life, using the "Audit of Diabetes-Dependent Quality of Life-15" (ADD-QoL-15)
Change in functional health and well-being, using the "SF-12v2® Health Survey"
Change in glycemic control, using Percent Time in Hyperglycemia
Change in glycemic control, using Percent Time in Hypoglycemia
Change in glycemic control, using Percent Time-in-Range

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Usual Care
1 of 2
Lifestyle Intervention
1 of 2
Active Control
Experimental Treatment

This trial requires 210 total participants across 2 different treatment groups

This trial involves 2 different treatments. Resilient, Empowered, Active Living-Telehealth (REAL-T) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Lifestyle Intervention
Behavioral
Resilient, Empowered, Active Living-Telehealth (REAL-T)
Usual CareParticipants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months for reporting.

Who is running the study

Principal Investigator
B. P.
Prof. Beth Pyatak, Associate Professor
University of Southern California

Closest Location

USC Center for Health Professionals - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
T1D for ≥12 months
A1c ≥7.5% at time of study enrollment
Age 18-30 yrs. at time of study enrollment
English or Spanish speaking
Resides in a state where OT clinicians are licensed, in an area where the participant has access to a local healthcare provider in the event of emergency and can complete data collection in person (when permitted) or via mailings (when required during period of social distance or due to distance from study site)
Participant has access to a laptop or desktop computer, either their own or loaned by the study (if geographically feasible and permitted given COVID-19 social distancing distractions)
Willing to participate in 6-month intervention

Patient Q&A Section

What are the signs of diabetes, autoimmune?

"People with diabetes or a family history of diabetes have a significantly higher prevalence of autoimmune diseases. Moreover, the relationship between diabetes and autoimmune diseases is likely to be modulated by gender and ageing." - Anonymous Online Contributor

Unverified Answer

What causes diabetes, autoimmune?

"A significant proportion of patients diagnosed with [type 1 diabetes](https://www.withpower.com/clinical-trials/type-1-diabetes) and/or insulin-dependent diabetes mellitus have autoimmune thyroid disease. Type 1 diabetes mellitus is associated with thyroid autoimmunity and diabetes-related autoantibodies against GAD65, ICA-2 and-1 and ICAM-1. These antibodies may be targeted in future clinical trials for diabetes autoimmunity in autoimmune thyroid disease." - Anonymous Online Contributor

Unverified Answer

Can diabetes, autoimmune be cured?

"We would argue that it is not possible to cure diabetes by restoring normoglycemia or type 1 diabetes remission. The aim of diabetes treatment is always to control blood glucose levels. Because glucose levels are controlled in most of these patients, the patients can be reassured and some of them can be in remission." - Anonymous Online Contributor

Unverified Answer

How many people get diabetes, autoimmune a year in the United States?

"About 23 million Americans have diabetes or pre-diabetes. Diabetic and pre-diabetic patients and their family members comprise an underserved sector of the population relative to their significant medical needs." - Anonymous Online Contributor

Unverified Answer

What are common treatments for diabetes, autoimmune?

"There are many treatments for diabetes including oral drugs like Metformin or Glipizide, and injections of Insulin or Glucagon. There are also very effective and well known non-pharmaceutical treatments like Exercise, Dental Care and Weight Loss Surgery.\n" - Anonymous Online Contributor

Unverified Answer

What is diabetes, autoimmune?

"Diabetes is a disorder caused by the failure of the pancreas to produce enough insulin, a hormone that helps the body process carbohydrates. It can be treated with insulin or medications or a combination of the two. Diabetes is most often found among people that are of African descent or Hispanic descent." - Anonymous Online Contributor

Unverified Answer

What is resilient, empowered, active living-telehealth (real-t)?

"A telehealth program is described which provides support for patients with diabetes and their health providers while providing real-time monitoring of the patient's condition. Both the participants and health care providers were satisfied with the program. Further research is needed to better understand how and why this program achieves such positive outcomes." - Anonymous Online Contributor

Unverified Answer

How serious can diabetes, autoimmune be?

"Diabetes and autoimmune diseases have been shown to be closely and progressively related. The association of both diseases is greater than chance variation due to diabetes or autoimmune diabetes. In many ways, the diseases seem closely related, in others, they appear to be causally related. There is still an open question of whether these associations are merely coincidental, or if diabetes and autoimmune diabetes are in fact the same process. This is a subject that requires further research." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving resilient, empowered, active living-telehealth (real-t)?

"This research provides the first example of a clinical trial that utilized the theory described here to support the healthful well-being of a group of people who struggled to do it. This trial's results point to the need to reconsider how telehealth could be used and to pay close attention to the unique challenges faced by certain populations who might benefit more from being empowered rather than challenged." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets diabetes, autoimmune?

"Diabetes in one generation is most likely to present in a female of the third decade. The age at diagnosis of diabetes is on the rise but on a small scale." - Anonymous Online Contributor

Unverified Answer

What does resilient, empowered, active living-telehealth (real-t) usually treat?

"RESULTS underscore the importance of engaging clients of this type of support in their treatment care. Providers should ensure that their current work does not overwhelm the goals and wishes of patients. Clinicians as well as those who work with this type of support should continue to pay heed to the work ethic of participants who have been engaged in these type of services for years and years. Additional training and support for such clients is needed to help increase knowledge on these types of services and to allow therapists to more effectively work within the constraints of these services." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for diabetes, autoimmune?

"Patients who are elderly, have diabetes, are infertile, or are pregnant should consider clinical trials for autoimmune diabetes. Patients with renal dysfunction undergoing dialysis should consider clinical trials for diabetes. Patients with prior gastrointestinal disease, past history of thyroid disease, current thyroid dysfunction, other autoimmune diseases, or abnormal LFTs should consider clinical trials for diabetes. Patients who have had prior thyroid intervention should consider clinical trials for autoimmune thyroid disease." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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