Image

Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes

Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes

Recruiting
65 years and older
All
Phase N/A

Powered by AI

Overview

Aim 1: Characterize shared decision-making and unmet patient-caregiver dyads needs for patients with diabetes and Alzheimer's Disease and related dementias (ADRD) while using a continuous glucose monitoring (CGM) device.

Aim 2: Develop an interactive tool to enhance shared decision-making for diabetes management.

Description

Aim 1: Patient-caregiver dyads will participant in a semi-structured interview to establish a baseline. The dyad will receive standard diabetes educational materials along with a CGM training and instructions for device use. Patients will then wear the CGM device for 14 days. Three follow-up interviews will take place during the 14-day scanning period, as well as a debrief interview following the scanning period for assessment and technical support.

Aim 2: Patient-caregiver dyads and clinicians will participate in a user-centered design session to guide the design of interactive information displays to improve the interpretability of CGM data.

Eligibility

Patient-Caregiver Dyad Inclusion Criteria (Aims 1 + 2):

  • patient must have dual diagnosis of MCI or ADRD and diabetes (DM)
  • patient must have active prescriptions for DM
  • patient must have had at least one visit to an Eskenazi or IU Health primary care clinic within 12 months
  • patient must be able to provide assent and have a legally authorized representative (LAR) consent on their behalf if patient lacks capacity to consent
  • patient must have a caregiver aged 18 years or older who interacts daily, or almost daily, with the patient
  • patient and caregiver must both speak English
  • patient and caregiver must both reside in the community
  • dyad must have internet access

Patient-Caregiver Dyad Exclusion Criteria (Aims 1 +2):

  • patient has terminal illness
  • use of an automated insulin delivery system
  • patient is receiving dialysis
  • patient is taking ascorbic acid during monitoring period
  • patient has existing implanted medical devices
  • patient has a bleeding disorder
  • patient has a pre-existing arm skin lesions
  • patient has an allergy to medical adhesive or isopropyl alcohol
  • patient has plans for imaging or diathermy treatment during the study period

Clinician Participant Inclusion Criteria (Aim 2):

  • primary care physicians
  • nurses
  • pharmacists
  • nutritionists
  • psychologists
  • medical residents

Clinician Participant Exclusion Criteria (Aim 2):

  • only treats patients younger than 65 years
  • does not manage patients' DM

Study details
    Diabetes
    Alzheimer's Disease (Incl Subtypes)
    Dementia
    Hypoglycemia

NCT05643144

Indiana University

3 May 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.