Clinical trial NCT05643144: 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
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Alzheimer's Disease (Incl Subtypes)
Dementia
Hypoglycemia
Keywords: Continuous glucose monitoring
Shared decision-making
Human factors
Primary care
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-12-08
Enrollment: 62
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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
* 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

Primary outcomes:
measure: Patient and Caregiver Unmet Needs (Aim 1)
timeFrame: 2 months
measure: Level of Situation Awareness (Aim 2)
timeFrame: 1 day
Secondary outcomes:
measure: Feasibility: Percentage of patients recruited (Aim 1)
timeFrame: 1 year
measure: Feasibility: Retention rate of participants (Aim 1)
timeFrame: 1 year
measure: Feasibility: CGM data completeness (Aim 1)
timeFrame: 2 months
measure: Hypoglycemia: Percentage of time below range (Aim 1)
timeFrame: 2 months
measure: Severe Hypoglycemia: Percentage of time below range (Aim 1)
timeFrame: 2 months
measure: Percentage of time in range (Aim 1)
timeFrame: 2 months
measure: Mean glucose (Aim 1)
timeFrame: 2 months
measure: Glucose management indicator (Aim 1)
timeFrame: 2 months
measure: Glucose variability (Aim 1)
timeFrame: 2 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
Study officials:
References: