Student Pharmacist Non-Pharmacological Intervention on Type 2 Diabetes Management in Older Asian Adult Populations

NCT ID: NCT06861491

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2026-04-30

Brief Summary

This study is being done to assess the impact of student pharmacist involvement on blood glucose control through non-pharmacological interventions in people of Asian and Asian descent over the age of 50 with type 2 diabetes. This study team is trying to advance the field of pharmacy and expand the roles of student pharmacists.

Detailed Description

This study aims to assess the clinical impact of student pharmacist-led interventions on glycemic control in adult populations. This study will specifically target adults aged 50 years and older of Asian or Asian-descent with diagnosed type 2 diabetes, residing in San Francisco. The goal of the study is to demonstrate the utility of pharmacy students in a community setting on chronic disease management through patient-specific education and interventions. The aims of this study are to compare glycemic control in patients with type 2 diabetes who receive continuous assessment and non-pharmacological counseling from student pharmacists versus those who do not. Specifically, this study will evaluate:

1. The impact of student pharmacist assessments and personalized recommendations on diet, exercise, and adherence to treatment regimens, and their lasting effects on blood glucose control.

2. If participants perceived any value and effect of student pharmacist involvement in managing chronic diseases.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-pharmacological intervention and education by student pharmacists

Student pharmacists will provide non-pharmacological recommendations to participants about lifestyle modifications, including exercise and diet, as well as provide information about current medications the participant is taking.

Group Type: EXPERIMENTAL

Non-pharmacological

Intervention Type: BEHAVIORAL

This intervention will be provided by student pharmacists. It will focus on lifestyle modifications, adherence, and education of disease state.

Control

Student pharmacists will collect data on participants, but will not provide recommendations on non-pharmacological management. However, they will provide online resources on diabetes management if prompted.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Non-pharmacological

This intervention will be provided by student pharmacists. It will focus on lifestyle modifications, adherence, and education of disease state.

Intervention Type: BEHAVIORAL

Other Intervention Names

Lifestyle; Diet; Exercise; Adherence

Eligibility Criteria

Inclusion Criteria

• Adults ≥ 50 years old
• Asian or Asian-descent
• Diagnosed with T2DM
• A1C >7.0% (uncontrolled)
• Take blood glucose measurements as prescribed by their physician, or consistently (defined as missing no more than 1 reading from their regular routine).

Exclusion Criteria

• Age < 50 years old
• Not diagnosed with type 2 diabetes, or have diagnoses such as type 1 diabetes, gestational diabetes, or medication induced diabetes
• Patients that are on medications that affect glycemic control
• Corticosteroids
• First-generation antipsychotics (e.g. chlorpromazine, perphenazine, phenothiazines)
• Immunosuppressants (e.g. tacrolimus, cyclosporine)
• Experiencing acute disease states
• Recent surgery/hospitalized within the last 3 months
• Active infections
• Non-adherence to blood glucose monitoring (defined as missing > 1 reading from their regular routine or not taking readings as prescribed by their doctor)
• Patients with late stage T2DM requiring insulin therapy
• Diagnosed with cancer, end-stage renal disease, end-stage liver disease
• Received any organ transplant

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Crystal Zhou, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Central Contacts

Crystal Zhou, PharmD

Role: CONTACT

crystal.zhou@ucsf.edu

(415) 476-2354

Jerril Jacob, BS in Biochemistry

Role: CONTACT

jerril.jacob@ucsf.edu

(510) 320-4977

Other Identifiers

24-42131

Identifier Type: -

Identifier Source: org_study_id