Enhancing Shared Decision-making to Prompt and Guide Individualized Care for People With Alzheimer's Disease and Diabetes
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Indiana University
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Level of Situation Awareness (Aim 2)
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
April Savoy
Assistant Professor
Indiana University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Level of Situation Awareness (Aim 2)
Time Frame: 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.
Patient and Caregiver Unmet Needs (Aim 1)
Time Frame: 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.
Secondary Outcomes
- Feasibility: Retention rate of participants (Aim 1)(1 year)
- Feasibility: Percentage of patients recruited (Aim 1)(1 year)
- Feasibility: CGM data completeness (Aim 1)(2 months)
- Hypoglycemia: Percentage of time below range (Aim 1)(2 months)
- Mean glucose (Aim 1)(2 months)
- Severe Hypoglycemia: Percentage of time below range (Aim 1)(2 months)
- Percentage of time in range (Aim 1)(2 months)
- Glucose management indicator (Aim 1)(2 months)
- Glucose variability (Aim 1)(2 months)