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

Sponsor
Joslin Diabetes Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05535478
Collaborator
Brown University (Other), Theoria Medical (Other)
20
1
13

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: STRIDE
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Deprescribing of Diabetes Treatment Regimens in Long Term Care (LTC) Residents With Alzheimer's Disease or Related Dementias (ADRD)
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: STRIDE Intervention

Educational intervention for clinicians

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

Outcome Measures

Primary Outcome Measures

  1. 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 [Baseline vs 6 months]

    HRM use will include any sulfonylurea use (i.e., glyburide, glipizide, glimepiride, or chlorpropamide) and any insulin use.

Secondary Outcome Measures

  1. Acceptability of the STRIDE Educational Program [6 months]

    The extent to which the program is agreeable to LTCF staff- using the Acceptability of Intervention Measure (AIM)

  2. Appropriateness of the STRIDE Educational Program [6 months]

    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)

  3. Feasibility of the STRIDE Educational Program [6 months]

    The extent to which the program is practical at the LTCF level- using the Feasibility of Intervention Measure (FIM)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Joslin Diabetes Center
  • Brown University
  • Theoria Medical

Investigators

  • Principal Investigator: Medha Munshi, MD, Joslin Diabetes Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT05535478
Other Study ID Numbers:
  • Pro00053280
First Posted:
Sep 10, 2022
Last Update Posted:
Sep 10, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Joslin Diabetes Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2022