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Type 2 DiabetesNCT05761886

Rural Area Pharmacist Intervention for Diabetes

A study testing telehealth-based clinical pharmacy intervention in people with Type 2 Diabetes, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of the project is to inform the system leaders regarding the feasibility and utility of having an embedded telehealth-based clinical pharmacist at rural primary care practices for supportive disease management of patients with Type 2 diabetes (T2D) and whether continuing and expanding the program within the… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
telehealth-based clinical pharmacy intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteUnited States
Study dates
16 May 2023to 26 Mar 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >= 18 years and <=75 years (since children have different incidence, management, and outcomes of Type 2 diabetes (T2D) compared to adults and older adults aged more than 75 years may have had their hemoglobin A1C (HbA1c) goals adjusted to higher thresholds)
  • HbA1c reading ≥ 8% recorded during 6 months prior to or up to 9 days after the encounter at the participating practices
  • Uncontrolled type 2 diabetes (ICD-10-CM code E11.XX) recorded in the EHR in the year prior to up to 1 week after the uncontrolled HbA1c reading

Who cannot join

  • Patients with gestational or type 1 diabetes
  • Those enrolled in any other chronic disease management programs delivered by non-physician healthcare professionals
  • Those receiving T2D care from an endocrinologist
  • Those receiving long term, hospice, or palliative care services
  • Those with serious mental illnesses (schizophrenia and other psychotic disorders, major depressive disorders, bipolar disorders, and borderline personality disorder)
  • Those with malignant cancer
  • Those with cognitive impairment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Rural Area Pharmacist Intervention for Diabetes - Management Using eHealth: A Pilot Study (RAPID-ME)

The goal of the project is to inform the system leaders regarding the feasibility and utility of having an embedded telehealth-based clinical pharmacist at rural primary care practices for supportive disease management of patients with Type 2 diabetes (T2D) and whether continuing and expanding the program within the system is worthwhile.

Read the detailed description

Improvement of suboptimal type 2 diabetes (T2D) management and outcomes in rural areas in the United States (US) is an urgent national health policy priority. Novel approaches such as telehealth and supportive clinical management of T2D by non-physician providers have been recommended to fill gaps in care. With specialty in drug therapy, clinical pharmacists are in a position to uniquely contribute to filling gaps in T2D management related to medication therapy, which are common and often the cause of adverse outcomes in patients with T2D. The objective of this pilot study is to determine the feasibility, acceptability, appropriateness, fidelity, barriers and facilitators of implementation, and preliminary effectiveness of a telehealth-based clinical pharmacy intervention to inform the design of a subsequently planned fully powered effectiveness-implementation trial of the intervention. This pilot study will involve randomization based on the days the patients had encounters at participating practices (4 in North Carolina). The 2 study arms will be: 1) Usual care, receiving standard practice of care managed by physicians, nurse practitioners, and physician assistants with access to chronic disease management services and 2) Intervention arm, receiving the intervention consisting of clinical pharmacy services including identification and resolution of medication-related problems and patient needs, optimization of medication regimen and T2D education and self-management support, in addition to usual care. The intervention will last for 3 months and will consist of biweekly video/phone calls between patients and the pharmacist. Based on recommendations from literature on pilot studies, the total planned sample size is 240 patients. Implementation science framework by Proctor and colleagues and scales by Weiner and colleagues (for feasibility, acceptability, appropriateness, and fidelity) and Consolidated Framework for implementation Research (for barriers and facilitators of intervention implementation) will guide collection of data on outcomes. for using complementary medicine and healthcare avoidance. The results of our work will facilitate wide implementation of the intervention and thereby improved outcomes.

Conditions
Type 2 Diabetes
Being tested
telehealth-based clinical pharmacy intervention
Keywords
Telehealth, Rural populations, Clinical pharmacy services
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • telehealth-based clinical pharmacy interventionOther

    The pharmacist will perform an initial comprehensive review of the medication regimen, make any adjustments, document those in the patient's electronic health record (EHR) and communicate with the patient's T2D care team as needed. They will also call (using an EHR-based software) the patient using phone/video to educate them about T2D self-management and identify any medication-related unmet needs. Periodic reviews of the medication regimen and roughly biweekly follow-up patient calls will occur with frequency based on need (as judged by the pharmacist). Patient intervention calls will be personalized depending on HbA1c levels, comorbidities, and medication complexity

Study groups in NCT05761886
Study groupRoleWhat they receive
telehealth-based clinical pharmacy interventionExperimentalwill 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
Receives: Other: telehealth-based clinical pharmacy intervention
usual careNo interventionwill 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient enrollment rates

    Proportion of eligible patients enrolled

    Measured: Month 13

  2. Proportion of patients with complete data

    Proportion of patients with complete data

    Measured: Month 17

  3. Proportion of respondents selecting a response - Feasibility

    Proportion of respondents selecting a response of agree/strongly agree (disagree/strongly disagree for negatively worded items) on 70% of the survey items measuring perspectives regarding whether it was possible for the respondents to perform the program activities

    Measured: Month 17

  4. Proportion of respondents selecting a response - Acceptability

    Proportion of respondents selecting a response of agree/strongly agree (disagree/strongly disagree for negatively worded items) on 70% of the survey items measuring perspectives regarding whether they approve and like the program

    Measured: Month 17

  5. Proportion of respondents selecting a response - Appropriateness

    Proportion of respondents selecting a response of agree/strongly agree (disagree/strongly disagree for negatively worded items) on 70% of the survey items measuring perspectives regarding program fit with the needs of the respondents

    Measured: Month 17

  6. Proportion of items self-reported by pharmacist - Fidelity

    Proportion of items self-reported by pharmacist by checking (yes/no/not applicable) in a task-list of program activities

    Measured: Month 17

Secondary outcomes (5)

  1. Change in HbA1c

    Change in HbA1c from baseline to follow-up - While the usually recommended HbA1c target is <7.0%, the American Diabetes Association recommends transitioning the HbA1c target to ≥8.0% based on factors such as age, limited life expectancy, complications, history of hypoglycemia, and comorbidities.

    Measured: Month 17

  2. Change in Blood Pressure

    Change in systolic and diastolic blood pressure from baseline to follow-up - A normal blood pressure can vary between individuals, but the American Heart Association recommend a target blood pressure below 120 mm Hg systolic and 80 mm Hg diastolic. Usually, hypertension is defined as blood pressure above 140/90 and is considered severe if the pressure is above 180/120.

    Measured: Month 17

  3. Number of Acute Care Days

    Change in the number of days spent in emergency room or hospital from baseline to follow-up

    Measured: Month 17

  4. Change in patient-reported medication adherence scores

    Change in patient-reported medication adherence score from baseline to follow-up measured by a survey

    Change in patient-reported medication adherence score from baseline to follow-up measured by a single item survey: "Over the past week, what percent of the time did you take all your diabetes medications as your doctor prescribed?" [11 response categories (0, 10, 20... 100%) with higher score indicating better adherence]

    Measured: Month 17

  5. Change in barriers to medication adherence

    Change in patient-reported barriers to medication adherence score from baseline to follow-up

    Adherence Starts with Knowledge-12 survey - measured by Adherence Starts with Knowledge-12 survey (Score can range from 12-60, with higher scores representing greater barriers to adherence.)

    Measured: Month 17

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2023
  2. Study start16 May 2023
  3. Primary completion12 Oct 2024
  4. Study completion26 Mar 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
the target sample size in our pilot study is 72 in the intervention group. The target for the control group is 168.
Masking
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05761886
Sponsor's protocol ID
IRB00094019
Status last verified
Jan 2025
First submitted
27 Feb 2023
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing telehealth-based clinical pharmacy intervention in people with Type 2 Diabetes, run by Wake Forest University Health Sciences 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 3 inclusion and 7 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 27 Apr 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?

Patient enrollment rates (time frame: Month 13). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05761886.

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 27 Apr 2025.

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