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

Sponsor

Indiana University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05643144

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arms

53.5

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Alzheimer's Disease (Incl Subtypes) Dementia Hypoglycemia	Device: Continuous Glucose Monitoring	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Enhancing Shared Decision-making to Prompt and Guide Individualized Care for People With Alzheimer's Disease and Diabetes

Anticipated Study Start Date :

Jan 15, 2023

Anticipated Primary Completion Date :

Jun 30, 2027

Anticipated Study Completion Date :

Jun 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient-Caregiver Dyads Participants will wear a continuous glucose monitor	Device: Continuous Glucose Monitoring CGM education and glucose data collection for 14 days with a device. Interviews with dyads to assess experience and awareness of hypoglycemic events.
No Intervention: Patient-Caregiver Dyads & Clinicians (first iteration) Participants will participate in the first iteration of the user-centered design process.
No Intervention: Patient-Caregiver Dyads & Clinicians (second iteration) Participants will participate in the second iteration of the user-centered design process.

Arm

Intervention/Treatment

Experimental: Patient-Caregiver Dyads

Participants will wear a continuous glucose monitor

Device: Continuous Glucose Monitoring

CGM education and glucose data collection for 14 days with a device. Interviews with dyads to assess experience and awareness of hypoglycemic events.

No Intervention: Patient-Caregiver Dyads & Clinicians (first iteration)

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

No Intervention: Patient-Caregiver Dyads & Clinicians (second iteration)

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

Outcome Measures

Primary Outcome Measures

Patient and Caregiver Unmet Needs (Aim 1) [2 months]
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) [1 day]
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) [1 year]
Recruitment Percentage = Participant total/Eligible population total
Feasibility: Retention rate of participants (Aim 1) [1 year]
Retention Rate = Completed participant total/Recruited participant total
Feasibility: CGM data completeness (Aim 1) [2 months]
Count of total days CGM worn [CGM performs calculation]
Hypoglycemia: Percentage of time below range (Aim 1) [2 months]
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) [2 months]
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) [2 months]
Percentage = glucose readings and time 70-180 mg/dL / total amount of readings and time monitored [CGM performs calculation]
Mean glucose (Aim 1) [2 months]
Mean = sum of glucose readings / total amount of glucose readings [CGM performs calculation]
Glucose management indicator (Aim 1) [2 months]
Estimated A1C automated calculation based on 14 days of CGM data [CGM performs calculation]
Glucose variability (Aim 1) [2 months]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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