Providing access to clinical trials for native American, veteran, and active-duty military patients can be a challenge, but a significant number of trials are now recruiting from those populations. Many trials explicitly recruit patients from the US Department of Veterans
Affairs (VA), the military, and Indian Health Service. The VA Office of Research and Development alone sponsors more than 480 research initiatives, and many more are sponsored by Walter Reed National Medical Center and other major defense and VA facilities. The clinical trials listed below are all open as of October 24, 2018; have at least 1 VA, DoD, or IHS location recruiting patients; and are focused on preventing diabetes mellitus or improving patient care. For additional information and full inclusion/exclusion criteria, please consult clinicaltrials. gov.
Diabetes Prevention Program Outcomes Study (DPPOS)
The Diabetes Prevention Program (DPP) was a multicenter trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%.
ID: NCT00038727
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases
Location: George Washington University, Rockville, Maryland
Efforts to Improve Diabetes Control
The primary objectives of this study are: (1) test the longterm effectiveness of a peer mentor model on improving glucose control, blood pressure, LDL levels, diabetes mellitus quality of life, and depression scores in a mixed race population of poorly controlled diabetic veterans; (2) test the effectiveness of using former peer mentees as peer mentors as a means of creating a self-sustaining program; and (3) test the effects of becoming a mentor on those who were originally mentees given a growing literature that being a mentor is good for your health. Secondary objectives include: (1) in those randomized to being a mentee, explore mentor characteristics associated with improved HbA1c.
ID: NCT01651117
Sponsor: VA Office of Research and Development
Location: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania
A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians
The goal of the proposed research is to identify effective patient-centered strategies to prevent diabetes in high-risk populations in real world settings. The investigators will accomplish this by conducting a randomized controlled trial comparing an enhanced Diabetes Prevention Program addressing psychosocial stressors to a standard version in a high-risk population of urban American Indian
and Alaskan Native peoples within a primary care setting.
ID: NCT02266576
Sponsor: Stanford University
Locations: Timpany Center of San Jose State University, California; Stanford University School of Medicine, California
Physical Activity and Participation
Physical activity is the cornerstone of good diabetes management, and yet effective physical activity intervention is not available. The investigators developed a lifestyle intervention based on individual’s home activity patterns. The goal of the study is to test the efficacy of this intervention among veterans with diabetes in a randomized-controlled trial. In addition to physical activity, the investigators will also assess if the intervention will improve social participation among veterans.
ID: NCT02268916
Sponsor: VA Office of Research and Development
Location: VA Ann Arbor Healthcare System, Michigan
Caring Others Increasing EngageMent in PACT (CO-IMPACT)
This trial will compare two methods of increasing engagement in care and success in diabetes management, among patients with diabetes with high-risk features, who also have family members involved in their care.
ID: NCT02328326
Sponsor: VA Office of Research and Development
Locations: VA Ann Arbor Healthcare System, Michigan;VA Pittsburgh Healthcare System, Pennsylvania
STEP UP to Avert Amputation in Diabetes (STEP UP)
This study will evaluate a comprehensive tailored behavioral intervention aimed to improve foot self-care and self-monitoring (combined with dermal thermometry) to prevent recurrent ulcers in Veterans at highest risk of amputation. This intervention may be a novel strategy for improving self-care and early detection of foot abnormalities in this at-risk population using psychological theories to target multiple health behaviors simultaneously. This could be an efficient and cost-effective approach to improve diabetes-related foot health behavior, and other risk factors in patients who are vulnerable to devastating consequences related to amputation.
ID: NCT02356848
Sponsor: VA Office of Research and Development
Location: Manhattan Campus of the VA NY Harbor Healthcare System
Physical Activity Behavior Change for Older Adults After Dysvascular Amputation (PABC)
This pilot study will use mobile-health technology to deliver an intervention designed for lasting physical activity behavior change. The study will assess the feasibility of using the Physical Activity Behavior Change (PABC) intervention for Veterans with lower limb amputation. This intervention will be delivered using wrist-worn wearable activity sensors and a home-based tablet computer to allow real-time physical activity feedback and video interface between the participants and the therapist.
ID: NCT02738086
Sponsor: VA Office of Research and Development
Location: Rocky Mountain Regional VA Medical Center, Aurora, Colorado
ForgIng New Paths to Prevent DIabeTes (FINDIT)
This study will evaluate the effects of screening for type 2 diabetes mellitus (T2DM) and brief counseling about screening test results on weight and key health behaviors among veterans with risk factors for T2DM. Study participants will be randomly assigned to 1 of 2 study groups: (1) Blood Test Group; or (2) Brochure Group. Participants in the Blood Test Group will complete a blood test called hemoglobin A1c (HbA1c) which measures average blood sugar levels. Participants will receive brief counseling about the results from their primary care provider or someone authorized to speak on their behalf. Participants randomly selected for the Brochure Group will review a handout from the VA National Center for Health Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations. All participants will be asked to complete a survey prior to study group assignment, immediately after a Primary Care appointment, 3 months after enrollment, and 12 months after enrollment.
ID: NCT02747108
Sponsor: VA Office of Research and Development
Location: VA Ann Arbor Healthcare System, Michigan
Using Technology to Share Fitness Goals and Results to Improve Diabetes Outcomes
The investigators will recruit DoD beneficiaries, aged 18 years or older and diagnosed with type 2 diabetes. Patients will be randomized into one of two groups. Group 1 will use a fitness tracker but will not be able to see other participants data and group 2 will use a fitness tracker and will be able to see other members daily and weekly results. Outcome measures will be assessed at baseline, 3 months and 6 months to include hemoglobin A1c, weight, body mass index, blood pressure, and number of hours and days fitness tracker is used. The goal is to see if the group randomized into an online community will have improved activity and outcome measurements compared with those who use the pedometer alone.
ID: NCT02761018
Sponsor: Mike O’Callaghan Military Hospital
Location: Mike O’Callaghan Federal Medical Center, Nellis Air Force Base, Nevada
Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study (HELP Vets)
Diabetes and obesity are both major public health concerns and the prevalence of diabetes is even higher in the patient population of the VA. This planning project is designed to adapt a successful weight-loss program for delivery through an existing outpatient clinic to reach local veterans at risk for developing diabetes. The information gathered as a part of this project will be used to plan a larger trial designed to improve the health of veterans by offering them a diabetes prevention program through their usual source of healthcare.
ID: NCT02835495
Sponsor: Wake Forest University Health Sciences
Location: Wake Forest School of Medicine
Mindful Stress Reduction in Diabetes Self-Management Education for Veterans (MindSTRIDE)
The purpose of this study is to see if adding Mindfulness training to diabetes education reduces feelings of stress and makes it easier to adhere to healthy behaviors that improve diabetes outcomes (such as hemoglobin A1c).
ID: NCT02928952
Sponsor: VA Office of Research and Development
Location: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, Pennsylvania
Improving Diabetes Care Through Effective Personalized Patient Portal Interactions
Patient-facing eHealth technologies are those that connect patients and the healthcare system, and include online patient portals. Although many organizations are adopting patient portals, there is limited understanding of how the different portal features help improve health outcomes. This study is designed to develop and test an intervention to improve adoption and use of patient portal features for diabetes management.
ID: NCT02953262
Sponsor: VA Office of Research and Development
Locations: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, Massachusetts; VA Boston Healthcare System Jamaica Plain Campus, Massachusetts.
Home-Based Kidney Care in Native American’s of New Mexico (HBKC)
People reach end stage renal disease (ESRD) due to progressive chronic kidney disease (CKD), which is associated with increased risk for heart disease and death. The burden of chronic kidney disease is increased among minority populations compared to Caucasians. New Mexico American Indians are experiencing an epidemic of chronic kidney disease due primarily to the high rates of obesity and diabetes. The present study entitled Home-Based Kidney Care is designed to delay / reduce rates of ESRD by early interventions in CKD. Investigators propose to assess the safety and efficacy of conducting a full-scale study to determine if home based care delivered
by a collaborative team composed of community health workers, the Albuquerque Area Indian Health Board and University of New Mexico faculty will decrease the risk for the development and the progression of CKD.
ID: NCT03179085
Sponsor: University of New Mexico
Location: University of New Mexico, Albuquerque
INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT)
This study will evaluate a VA MyHealtheVet Secure Messaging intervention that uses different intervention messaging strategies designed to increase engagement in behaviors to prevent type 2 diabetes (T2DM). After completing a baseline survey, participants will be randomly assigned to receive different novel presentations of information about ways to prevent T2DM through both secure messaging and US mail. The investigators will test the 5 presentations that each: (1) represent an innovative approach from behavioral economics or health psychology with great promise to increase engagement in behaviors to prevent T2DM among patients with prediabetes; and (2) have not been tested in this setting.
ID: NCT03403231
Sponsor: VA Office of Research and Development
Location: VA Ann Arbor Healthcare System, Michigan
Self-efficacy, Beliefs and Adherence—Pilot and Feasibility Trial of a Pharmacist-led Intervention
This study uses an intervention mixed methods design. The overall purpose is to improve medication adherence and assess the clinical impact on diabetes outcomes among patients with uncontrolled diabetes. We will examine if usual care combined with a clinic-based health literacy/psychosocial support intervention improves medication adherence compared to usual care alone. A randomized controlled trial will be conducted at William S. Middleton Memorial Veterans Hospital in Madison, targeting individuals with
uncontrolled diabetes. The patient-centered health literacy intervention will focus on enhancing patients’ self-efficacy and addressing patients’ negative beliefs in medicine and illness.
ID: NCT03406923
Sponsor: University of Wisconsin, Madison
Location: William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin
Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus (PRACTICE-DM)
Diabetes generates significant morbidity, mortality, and costs within the Veterans Health Administration (VHA). Veterans with persistently poor diabetes control despite clinic-based care are among the highest-risk diabetes patients in VHA, and contribute disproportionately to VHA’s massive burden of diabetes complications and costs. VHA critically needs effective, practical management alternatives for veterans whose diabetes does not respond to clinic-based management. The proposed study will address this need by leveraging VHA’s unique Home Telehealth capacity to deliver comprehensive telemedicine-based management for veterans with persistently poor diabetes control despite clinic-based care. Because this intensive intervention is delivered using only existing Home Telehealth workforce, infrastructure, and technical resources—which are ubiquitous at VHA centers nationwide—it could represent an effective, practical approach to improving outcomes in veterans with PPDM, potentially translating to a substantial reduction in VHA’s diabetes burden.
ID: NCT03520413
Sponsor: VA Office of Research and Development
Locations: Durham VA Medical Center, North Carolina; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia
Cooking for Health
Type 2 diabetes is a leading cause of morbidity and mortality among American Indians in the US. Although healthy diet is a key component of diabetes management programs, many American Indians face contextual barriers to adopting a healthy diet including: difficulty budgeting for food on low-incomes, low literacy and numeracy when purchasing food, and limited cooking skills. The proposed project will develop, implement, and evaluate a culturally-targeted healthy foods budgeting, purchasing, and cooking skills intervention aimed at improving the cardio-metabolic health of American Indians with type 2 diabetes who live in rural areas.
ID: NCT03699709
Sponsor: University of Washington
Location: Missouri Breaks Industries Research, Eagle Butte, South Dakota