DiabetesNCT05535478
Deprescribing of Diabetes Regimens in Long Term Care Residents With Alzheimer's
A study testing STRIDE in people with Diabetes and Dementia, run by Joslin Diabetes Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Dementia, Hypoglycemia; Drug
- What is being tested?
- STRIDE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2023to 14 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Consistent with the pragmatic nature of the trial, there are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deprescribing of Diabetes Treatment Regimens in Long Term Care (LTC) Residents With Alzheimer's Disease or Related Dementias (ADRD)
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.
- Conditions
- Diabetes, Dementia, Hypoglycemia; Drug
- Being tested
- STRIDE
- Keywords
- older adults, long term care facility, high risk medications, hypoglycemia, deprescribing, diabetes, dementia
- Medical subject headings
- Diabetes Mellitus, Dementia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRIDEBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| STRIDE Intervention | Other | Educational intervention for clinicians Receives: Behavioral: STRIDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline vs 6 months
Secondary outcomes (3)
Acceptability of the STRIDE Educational Program
The extent to which the program is agreeable to LTCF staff- using the Acceptability of Intervention Measure (AIM)
Measured: 6 months
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)
Measured: 6 months
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start31 Jan 2023
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, Theoria Medical
- Responsible party
- Sponsor
- Investigators
- Medha Munshi, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535478
- Sponsor's protocol ID
- Pro00053280
- Status last verified
- Jul 2025
- First submitted
- 26 Aug 2022
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deprescribing of Diabetes Treatment Regimens in Long Term Care (LTC) Residents With Alzheimer's Disease or Related Dementias (ADRD)
- ClinicalTrials.gov ID
- NCT05535478
- Acronym / sponsor ID
- Pro00053280
- Conditions
- Diabetes, Dementia, Hypoglycemia; Drug
- Keywords
- older adults, long term care facility, high risk medications, hypoglycemia, deprescribing, diabetes, dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Brown University, Theoria Medical
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STRIDE Intervention | Other | Behavioral: STRIDEEducational intervention for clinicians |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Consistent with the pragmatic nature of the trial, there are no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STRIDEa. 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 | Behavioural | STRIDE Intervention |
Primary outcome
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
Time frame: Baseline vs 6 months
HRM use will include any sulfonylurea use (i.e., glyburide, glipizide, glimepiride, or chlorpropamide) and any insulin use.
3 secondary outcomes
Acceptability of the STRIDE Educational Program
Time frame: 6 months
Appropriateness of the STRIDE Educational Program
Time frame: 6 months
Feasibility of the STRIDE Educational Program
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medha Munshi, MD principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STRIDE in people with Diabetes and Dementia, run by Joslin Diabetes Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline vs 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.