Prepare for Your Diabetes Care

NCT05263310 | Active Not Recruiting DMC

• 2 other identifiers: IRB-1635322R01AG068133
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus With Hypoglycemia; Aging; Patient Activation

Outcome Measures

Primary Outcomes (1)

• Any incidence of hypoglycemia

  Any one of the following hypoglycemia event measures: * Self-report to survey question: Have you had three or more symptomatic hypoglycemia episodes in past 4 weeks (survey administered at month 6 and month 12) * Self-report to survey question: Have you had one or more severe hypoglycemia episodes in past 6 months that resulted in passing out or needing active help from someone else (survey administered at month 6 and month 12) * Clinical record of any emergency department or hospital admission with primary admitting diagnosis of hypoglycemia during the 12-month study period

  12 months after baseline date

Secondary Outcomes (8)

• Patient-Reported Outcome: Incidence of Severe Self-Reported Hypoglycemia

  Preceding 6-month period (asked 6 and 12 months after first study-related visit)]

• Patient-Reported Outcome: Incidence of Symptomatic Self-Reported Hypoglycemia

  Preceding 1-month period (asked 6 and 12 months after first study-related visit)

• Patient-Reported Outcome: Problem Areas in Diabetes

  6 and 12 months following the first study-related visit

• Clinical Utilization Outcome: Hypoglycemic-related admissions to Emergency Department or Hospital

  6 and 12 months following the first study-related visit

• Patient-Centered Outcome: RAND Patient Satisfaction Questionnaire

  6 and 12 months following the first study-related visit

Study Arms (2)

Educational Video and Action Plan handout

EXPERIMENTAL

Patients in the intervention arm will be given access to an educational video (Prepare for Your Diabetes Care) and will be supported in viewing the video and the Action Plan handout. This program will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps with the participant's primary care provider.

Behavioral: Prepare for Your Diabetes Care

Usual Care

ACTIVE COMPARATOR

Patients in the control arm will continue with usual care and also complete baseline, 6-month, and 12-month surveys

Behavioral: Usual Care

Interventions

Prepare for Your Diabetes Care BEHAVIORAL

Educational video and Action Plan handout

Educational Video and Action Plan handout

Usual Care BEHAVIORAL

Control arm patients will continue with usual care

Usual Care

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 75 years
• Type 2 diabetes with last measured HbA1c ≤ 8.0%
• Currently prescribed insulin and/or SUs
• Kaiser Permanente Northern California member

You may not qualify if:

• Unable to communicate in English
• Unable to provide informed consent and/or participate in informed decision making due to cognitive or communication-related deficits
• Excluded by their primary care provider

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Kaiser Permanente - Oakland Medical Center

Oakland, California, 94577, United States

Location

Related Publications (1)

• Lee AK, Mejia JJ, Ferguson C, Li BH, Grant RW, Sudore RL. Expanded care planning paradigm for older adults with type 2 diabetes: Rationale, design, and protocol of the PREPARE for Your Diabetes Care randomized trial. Contemp Clin Trials. 2025 Jun;153:107913. doi: 10.1016/j.cct.2025.107913. Epub 2025 Apr 11.

  PMID: 40222399 DERIVED

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Richard W Grant, MD MPH

  Kaiser Permanente Northern California - Division of Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: care provider will not be informed of patient status; outcomes assessor will be blinded to allocation status
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pragmatic, clinical efficacy, patient-level randomized clinical trial

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 2, 2022
• Study Start: April 25, 2022
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)