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

Primary Purpose

Diabetes, Alzheimer's Disease (Incl Subtypes), Dementia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Glucose Monitoring
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes focused on measuring Continuous glucose monitoring, Shared decision-making, Human factors, Primary care

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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 patient has prior use of CGM device 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

Sites / Locations

  • Eskenazi HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Patient-Caregiver Dyads

Patient-Caregiver Dyads & Clinicians (first iteration)

Patient-Caregiver Dyads & Clinicians (second iteration)

Arm Description

Participants will wear a continuous glucose monitor

Participants will participate in the first iteration of the user-centered design process.

Participants will participate in the second iteration of the user-centered design process.

Outcomes

Primary Outcome Measures

Patient and Caregiver Unmet Needs (Aim 1)
Semi-structured Interviews: Baseline interview questions will be framed by validated psychometric measurements of hypoglycemia unawareness, fear of hypoglycemia, ADRD quality of life, and DM distress. Observation interviews will be conducted to elicit patients' and caregivers' perceptions about hypoglycemia and describe their specific risks (e.g., nutrition, resources, stress, finances). Debrief interviews will review CGM data with participants and ask clarifying questions to elicit descriptions of their overall experiences.
Level of Situation Awareness (Aim 2)
Contextual Inquiries: With and without examples of information displays present, we will invite participants questions related to identifying and reading glucose values (e.g., identify glycemic targets), and articulate perceived important information at specific decision points.

Secondary Outcome Measures

Feasibility: Percentage of patients recruited (Aim 1)
Recruitment Percentage = Participant total/Eligible population total
Feasibility: Retention rate of participants (Aim 1)
Retention Rate = Completed participant total/Recruited participant total
Feasibility: CGM data completeness (Aim 1)
Count of total days CGM worn [CGM performs calculation]
Hypoglycemia: Percentage of time below range (Aim 1)
Percentage = glucose readings and time 54-69 mg/dL / total amount of readings and time monitored [CGM performs calculation]
Severe Hypoglycemia: Percentage of time below range (Aim 1)
Percentage = glucose readings and time <54 mg/dL / total amount of readings and time monitored [CGM performs calculation]
Percentage of time in range (Aim 1)
Percentage = glucose readings and time 70-180 mg/dL / total amount of readings and time monitored [CGM performs calculation]
Mean glucose (Aim 1)
Mean = sum of glucose readings / total amount of glucose readings [CGM performs calculation]
Glucose management indicator (Aim 1)
Estimated A1C automated calculation based on 14 days of CGM data [CGM performs calculation]
Glucose variability (Aim 1)
Oscillations in blood glucose levels: Measurement of fluctuations of glucose or other related parameters of glucose homoeostasis over a given interval of time (i.e., within a day, between days or longer term) [CGM performs calculation]

Full Information

First Posted
November 11, 2022
Last Updated
September 1, 2023
Sponsor
Indiana University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05643144
Brief Title
Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes
Official Title
Enhancing Shared Decision-making to Prompt and Guide Individualized Care for People With Alzheimer's Disease and Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
August 17, 2026 (Anticipated)
Study Completion Date
August 17, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Alzheimer's Disease (Incl Subtypes), Dementia, Hypoglycemia
Keywords
Continuous glucose monitoring, Shared decision-making, Human factors, Primary care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient-Caregiver Dyads
Arm Type
Experimental
Arm Description
Participants will wear a continuous glucose monitor
Arm Title
Patient-Caregiver Dyads & Clinicians (first iteration)
Arm Type
No Intervention
Arm Description
Participants will participate in the first iteration of the user-centered design process.
Arm Title
Patient-Caregiver Dyads & Clinicians (second iteration)
Arm Type
No Intervention
Arm Description
Participants will participate in the second iteration of the user-centered design process.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitoring
Intervention Description
CGM education and glucose data collection for 14 days with a device. Interviews with dyads to assess experience and awareness of hypoglycemic events.
Primary Outcome Measure Information:
Title
Patient and Caregiver Unmet Needs (Aim 1)
Description
Semi-structured Interviews: Baseline interview questions will be framed by validated psychometric measurements of hypoglycemia unawareness, fear of hypoglycemia, ADRD quality of life, and DM distress. Observation interviews will be conducted to elicit patients' and caregivers' perceptions about hypoglycemia and describe their specific risks (e.g., nutrition, resources, stress, finances). Debrief interviews will review CGM data with participants and ask clarifying questions to elicit descriptions of their overall experiences.
Time Frame
2 months
Title
Level of Situation Awareness (Aim 2)
Description
Contextual Inquiries: With and without examples of information displays present, we will invite participants questions related to identifying and reading glucose values (e.g., identify glycemic targets), and articulate perceived important information at specific decision points.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Feasibility: Percentage of patients recruited (Aim 1)
Description
Recruitment Percentage = Participant total/Eligible population total
Time Frame
1 year
Title
Feasibility: Retention rate of participants (Aim 1)
Description
Retention Rate = Completed participant total/Recruited participant total
Time Frame
1 year
Title
Feasibility: CGM data completeness (Aim 1)
Description
Count of total days CGM worn [CGM performs calculation]
Time Frame
2 months
Title
Hypoglycemia: Percentage of time below range (Aim 1)
Description
Percentage = glucose readings and time 54-69 mg/dL / total amount of readings and time monitored [CGM performs calculation]
Time Frame
2 months
Title
Severe Hypoglycemia: Percentage of time below range (Aim 1)
Description
Percentage = glucose readings and time <54 mg/dL / total amount of readings and time monitored [CGM performs calculation]
Time Frame
2 months
Title
Percentage of time in range (Aim 1)
Description
Percentage = glucose readings and time 70-180 mg/dL / total amount of readings and time monitored [CGM performs calculation]
Time Frame
2 months
Title
Mean glucose (Aim 1)
Description
Mean = sum of glucose readings / total amount of glucose readings [CGM performs calculation]
Time Frame
2 months
Title
Glucose management indicator (Aim 1)
Description
Estimated A1C automated calculation based on 14 days of CGM data [CGM performs calculation]
Time Frame
2 months
Title
Glucose variability (Aim 1)
Description
Oscillations in blood glucose levels: Measurement of fluctuations of glucose or other related parameters of glucose homoeostasis over a given interval of time (i.e., within a day, between days or longer term) [CGM performs calculation]
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 patient has prior use of CGM device 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
April Savoy, PhD
Phone
317-278-2194
Email
asavoy@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Roth, MPH
Phone
317-274-9053
Email
samroth@regenstrief.org
Facility Information:
Facility Name
Eskenazi Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Noblet

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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