NCT05535478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

2.5 years

First QC Date

August 26, 2022

Last Update Submit

July 28, 2025

Conditions

Keywords

older adultslong term care facilityhigh risk medicationshypoglycemiadeprescribingdiabetesdementia

Outcome Measures

Primary Outcomes (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

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

    Baseline vs 6 months

Secondary Outcomes (3)

  • Acceptability of the STRIDE Educational Program

    6 months

  • Appropriateness of the STRIDE Educational Program

    6 months

  • Feasibility of the STRIDE Educational Program

    6 months

Study Arms (1)

STRIDE Intervention

OTHER

Educational intervention for clinicians

Behavioral: STRIDE

Interventions

STRIDEBEHAVIORAL

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

STRIDE Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Diabetes MellitusDementiaHypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Medha Munshi, MD

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2022

First Posted

September 10, 2022

Study Start

January 31, 2023

Primary Completion

July 14, 2025

Study Completion

July 14, 2025

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations