Deprescribing of Diabetes Regimens in Long Term Care Residents With Alzheimer's

Diabetes Clinical Trial

Official title:

Deprescribing of Diabetes Treatment Regimens in Long Term Care (LTC) Residents With Alzheimer's Disease or Related Dementias (ADRD)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05535478
• Other study ID #: Pro00053280
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objectives To 1) examine the ability of the STRIDE (Simplification of Treatment Regimens and Individualized Diabetes Education) educational program to increase deprescribing of high hypoglycemia risk glucose-lowering medications (HRMs) among long term care facility (LTCF) residents with ADRD, 2) assess key implementation constructs (secondary outcomes) of the STRIDE program, including acceptability, appropriateness, and feasibility, and 3) validate the primary HRM use outcome measure.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: July 31, 2024
• Est. primary completion date: June 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical staff at the LTCF (MDs, PAs, NPs, clinical pharmacists) - (Targeted providers for STRIDE program)
• Clinical staff that participated in the STRIDE program (Providers doing stakeholder exit interviews)

Exclusion Criteria:

• Consistent with the pragmatic nature of the trial, there are no exclusion criteria.

Related Conditions & MeSH terms

• Dementia
• Diabetes
• Diabetes Mellitus
• Hypoglycemia

Intervention

Behavioral:
• STRIDE
a. Targeted providers for STRIDE program: i. Clinical staff at the LTCF who participate in deprescribing at the facilities (physicians (MDs), physician's assistants (PAs), nurse practitioners (NPs), clinical pharmacists): clinical staff members caring for LTCF residents with ADRD and diabetes at 6 LTCFs in the Ohio and Michigan areas will be invited via email from the LTCF leadership to participate in the STRIDE education program. The STRIDE program consist of practical algorithms and educational material, which they are free to view at any time, and participation in 2 webinars and monthly telementoring calls

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Joslin Diabetes Center	Brown University, Theoria Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proportion of long term care facility (LTCF) residents with Alzheimer's disease adn related dementias (ADRD) and diabetes with high risk medications (HRM) use	HRM use will include any sulfonylurea use (i.e., glyburide, glipizide, glimepiride, or chlorpropamide) and any insulin use.	Baseline vs 6 months
Secondary	Acceptability of the STRIDE Educational Program	The extent to which the program is agreeable to LTCF staff- using the Acceptability of Intervention Measure (AIM)	6 months
Secondary	Appropriateness of the STRIDE Educational Program	The extent to which the program is suitable for a particular purpose, i.e., to improve the frequency at which LTCF staff attempt diabetes medication regimen deprescribing- using the Intervention Appropriateness Measure (IAM)	6 months
Secondary	Feasibility of the STRIDE Educational Program	The extent to which the program is practical at the LTCF level- using the Feasibility of Intervention Measure (FIM)	6 months