Prepare for Your Diabetes Care

Status Recruiting

Clinical Trial Summary

As adults with type 2 diabetes age, they are increasingly vulnerable to treatment-related hypoglycemia and its related complications (including hospitalization and death). This study proposes to evaluate, in a randomized clinical trial, a strategy of expanded advance care planning to support older adults in value-aligned re-assessment of diabetes treatment regimens with their primary care team. If the aims of this project are achieved and incidence of clinically-significant hypoglycemia is reduced, this Prepare for Your Diabetes web-based patient educational care strategy could be scaled and applied in a wide variety of healthcare settings and chronic conditions in which evolving risks, benefits, and consequences of treatment require re-assessment with age.

Clinical Trial Description

In this pragmatic, clinical efficacy, parallel group randomized clinical trial, the study will enroll eligible Kaiser Permanente Northern California members (age 75 years or greater, type 2 diabetes, prescribed insulin or sulfonylureas [SUs], and last measured HbA1c <=8%). Participants randomly allocated to the intervention arm will view the Prepare for Your Diabetes Care web-based educational module that is designed to help them prepare to discuss their diabetes medication regimens with their primary care providers and receive an Action Plan handout. Participants randomly allocated to the control arm will continue with usual care. All participants will complete baseline, 6-month, and 12-month surveys. The hypothesis is that empowering high-risk patients to engage in values-based discussions about diabetes treatment intensity will result - when clinically appropriate - in decreases in diabetes regimen intensity leading to decreased incidence of hypoglycemia over the 12-month study period. If successful, this study will provide evidence to support strategies for safer treatment in older adults with type 2 diabetes. ;

Study Design

Related Conditions & MeSH terms

Aging
Diabetes Mellitus, Type 2
Hypoglycemia
Patient Activation
Type 2 Diabetes Mellitus With Hypoglycemia

Clinical Trial Details

NCT number	NCT05263310
Study type	Interventional
Source	Kaiser Permanente
Contact	Ilana Peterson, MPH
Phone	877-220-3022
Email	prepareresearchstudy@kp.org
Status	Recruiting
Phase	N/A
Start date	April 25, 2022
Completion date	March 30, 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05433233` - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension	N/A
Recruiting	`NCT06032065` - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)	Phase 3
Completed	`NCT05293730` - Trial of the Impact of the Electronic Frailty Integrated With Social Needs	N/A
Recruiting	`NCT03932162` - Gene Expression Changes In Young and Geriatric Skin	Early Phase 1
Completed	`NCT04064528` - Effects of Age on Amino Acid Delivery to Tendon	N/A
Completed	`NCT03366129` - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed	`NCT06029920` - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment	N/A
Recruiting	`NCT05543980` - Leg Heat Therapy in Elderly Individuals	Phase 2
Recruiting	`NCT05566938` - Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly	N/A
Completed	`NCT04894929` - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement	N/A
Not yet recruiting	`NCT06071130` - Emotion, Aging, and Decision Making	N/A
Enrolling by invitation	`NCT04641663` - Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST)	N/A
Completed	`NCT04088006` - The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity	N/A
Completed	`NCT03695081` - Patient Pathway Pharmacist - Optimal Drug-related Care	N/A
Recruiting	`NCT05424263` - Acetate and Age-associated Arterial Dysfunction	Phase 2
Completed	`NCT05601713` - Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling	N/A
Completed	`NCT04551339` - Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19	N/A
Recruiting	`NCT04997577` - Speech Perception and High Cognitive Demand	N/A
Completed	`NCT05922475` - Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training	N/A
Completed	`NCT04015479` - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.