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Telehealth Pharmacist Intervention for Type 2 Diabetes

N/A
Recruiting
Led By Rohan Mahabaleshwarkar, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 17
Awards & highlights

Study Summary

This trial studies if having a pharmacist help rural patients with Type 2 Diabetes in primary care will be beneficial.

Who is the study for?
This trial is for adults aged 18 to 75 living in rural areas with uncontrolled Type 2 diabetes, as shown by their health records. Participants must have a recent HbA1c level of at least 8%. People with cancer, other chronic disease programs, specialist T2D care, or serious mental illnesses are excluded.Check my eligibility
What is being tested?
The study tests if having a pharmacist provide telehealth support for diabetes management in rural primary care helps control Type 2 diabetes better and if it's worth expanding this service within the healthcare system.See study design
What are the potential side effects?
Since this trial involves telehealth services rather than medication or medical procedures, traditional side effects are not expected. However, there may be indirect effects related to changes in diabetes management.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 17
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 17 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient enrollment rates
Proportion of items self-reported by pharmacist - Fidelity
Proportion of patients with complete data
+3 more
Secondary outcome measures
Change in Blood Pressure
Change in HbA1c
Change in barriers to medication adherence
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: telehealth-based clinical pharmacy interventionExperimental Treatment1 Intervention
will involve a pharmacist identifying and addressing medication-related problems (e.g., inappropriate dosage or indications, drug interactions, and therapeutic duplication); optimizing medication regimens (discontinuing if appropriate, providing subsidized and generic options, and reducing medication complexity); and providing T2D education and self-management support
Group II: usual careActive Control1 Intervention
will involve routine physician office visits every 3 (for those with HbA1c outside goal) - or every 6 months (for those with HbA1c within goal). Medication regimens are usually managed by physicians, nurse practitioners, and physician assistants, and Patients have access to centralized chronic disease management programs.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,003,997 Total Patients Enrolled
Duke UniversityOTHER
2,360 Previous Clinical Trials
3,420,090 Total Patients Enrolled
Rohan Mahabaleshwarkar, PhDPrincipal InvestigatorAtrium Health Wake Forest University Health Sciences

Media Library

Telehealth-based Clinical Pharmacy Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05761886 — N/A
Type 2 Diabetes Research Study Groups: usual care, telehealth-based clinical pharmacy intervention
Type 2 Diabetes Clinical Trial 2023: Telehealth-based Clinical Pharmacy Intervention Highlights & Side Effects. Trial Name: NCT05761886 — N/A
Telehealth-based Clinical Pharmacy Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05761886 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor open to participants over two decades old?

"Eligibility for this research entails individuals who are between 18 and 75 years of age."

Answered by AI

Are there any qualifications for prospective participants of this research endeavor?

"This clinical trial is enrolling up to 240 people with type 2 diabetes, aged from 18 to 75."

Answered by AI

Is enrollment available for this clinical trial currently?

"Data hosted on clinicaltrials.gov reveals that recruitment for this medical experiment has been suspended. Despite the trial's initial posting date of April 1st 2023 and its latest update being February 27th, participants are no longer being accepted into the study. However, there are presently 1299 other trials recruiting patients at this current time."

Answered by AI

What is the ambition of this experiment?

"The key metric of this trial, which will be assessed after a period lasting approximately Month 10 is the Proportion of participants with complete data. Other secondary objectives include measuring any alterations in Blood Pressure (normally below 120/80 mm Hg), counting Acute Care Days spent at hospital or emergency room settings, and surveying patients for their self-reported medication adherence scores (measured by asking "Over the past week, what percent of the time did you take all your diabetes medications as your doctor prescribed?")."

Answered by AI
~0 spots leftby May 2024