DiabetesNCT04376112
Influence of Pharmacist and Student Pharmacists on Medication Adherence in Community Pharmacy Setting in Underserved Population
A study testing Pharmacist and pillpack intervention in people with Diabetes and Medication Non Adherence, run by Loma Linda University at 1 site in United States.
Trial summary
The overall objective is to examine the influence of various services provided by the community pharmacy on patients' diabetes and diabetes-related health outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Medication Non Adherence, Blood Pressure
- What is being tested?
- Pharmacist and pillpack intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2020to 1 Jan 2021
- 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
- ≥18 years of age, any gender
- Hemoglobin A1c >8.5%
- Taking total of ≥5 medications and taking ≥2 anti-diabetes medications
Who cannot join
- Unable to give informed consent
- Individuals included in Inland Empire Health Plan's Complex Care Program
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Pharmacy at SACHS
San Bernardino, California, 92410
About this study
The overall objective is to examine the influence of various services provided by the community pharmacy on patients' diabetes and diabetes-related health outcomes.
Read the detailed description
Diabetes affects approximately 30.3 million people in the U.S. and is the 7th leading cause of death (ADA 2019). Uncontrolled diabetes leads to various complications including cardiovascular disease, kidney disease, diabetic retinopathy, peripheral neuropathy, and lower extremity amputation. Estimated healthcare expenditure for individuals with diabetes is approximately $327 billion per year (ADA 2017). In San Bernardino County, the prevalence of diabetes was higher (12.4%) than the national rate (9.4%). More specifically, the federally qualified health center in which the Loma Linda University (LLU) community pharmacy serves has a diabetes prevalence rate of about 16% (HRSA 2017). To decrease risk of diabetes complications, HbA1c is recommended to be <7% in most patients; however, about 35% of the investigator's patient population have poorly controlled diabetes which is defined as HbA1c >9% (ADA 2019). Given high prevalence rates of uncontrolled diabetes in this high-risk population, it is pivotal that individuals are provided with appropriate diabetes self-management strategies, regular monitoring, and preventative care by their primary care provider to adequately control the disease. Numerous studies illustrate that clinical pharmacists improve health outcomes for chronic disease managements with medication therapy management (MTM) services in underserved patients. Additionally, team-based or coordinated care with the community pharmacist and the patient's health care providers has also demonstrated to assist with improvements in clinic outcomes of chronic diseases. Recently, combination of blister packaging and MTM services have been shown to improve medication adherence and clinical endpoints. Given the high prevalence of diabetes in this community, there is a critical need to achieve improvement in clinical diabetes outcomes possibly via monthly blister packaging and MTM services including point-of-care testing (POCT).
- Being tested
- Pharmacist and pillpack intervention, Standard of care
- Medical subject headings
- Diabetes Mellitus, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist and pillpack interventionOther
These participants will be randomized into one of the following two cohorts: standard of care (SOC) and pharmacy intervention group (blister packaging + MTM services). For pharmacy intervention (PI) group, the POCT will be used to measure HbA1c and blood pressure (BP) at baseline, 3, and 6 months during medication therapy management (MTM) service. Recommendation from MTM services will be documented in the patients' electronic medical records (EMRs) and shared with their primary care providers. For the SOC group, HbA1c and BP will be measured at the physician's office and researchers will have an access to participants' EMR.
Standard of careOther
None. Regular visits to primary care physician. Will measure HbA1c and blood pressure at baseline, 3, and 6 months
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Not described Receives: Other: Standard of care |
| Pharmacist Intervention | Experimental | Not described Receives: Other: Pharmacist and pillpack intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin A1c
Finger prick for HgA1c at baseline and at 6 months. Goal < 7% normal above 7% is abnormal
Measured: Change between baseline and 6 months
blood pressure
Blood pressure will be checked at baseline and at 6 months. Goal BP is 130/80 mmHg and above 130/80 mmHg is abnormal.
Measured: Change between baseline and 6 months
Medication adherence
Adherence of medication will be determined by patients picking up their medications. Patient profile will track every insurance claims for the medications. The proportion of days covered indicates the medication adherence, and it will be calculated at the end of 6 months.
Measured: Change between baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study startOct 2020 (estimated)
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Why it stopped: withdrawn due to lack of enrollment secondary to COVID-19 and the pharmacy being sold to a non-LLU system
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.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376112
- Sponsor's protocol ID
- 5190360
- Status last verified
- Apr 2022
- First submitted
- 23 Sep 2019
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pharmacist and Student Pharmacists on Medication Adherence in Community Pharmacy Setting in Underserved Population
- ClinicalTrials.gov ID
- NCT04376112
- Acronym / sponsor ID
- 5190360
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn due to lack of enrollment secondary to COVID-19 and the pharmacy being sold to a non-LLU system
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 6 May 2020 (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.
The overall objective is to examine the influence of various services provided by the community pharmacy on patients' diabetes and diabetes-related health outcomes.
Detailed description
Diabetes affects approximately 30.3 million people in the U.S. and is the 7th leading cause of death (ADA 2019). Uncontrolled diabetes leads to various complications including cardiovascular disease, kidney disease, diabetic retinopathy, peripheral neuropathy, and lower extremity amputation. Estimated healthcare expenditure for individuals with diabetes is approximately $327 billion per year (ADA 2017). In San Bernardino County, the prevalence of diabetes was higher (12.4%) than the national rate (9.4%). More specifically, the federally qualified health center in which the Loma Linda University (LLU) community pharmacy serves has a diabetes prevalence rate of about 16% (HRSA 2017). To decrease risk of diabetes complications, HbA1c is recommended to be <7% in most patients; however, about 35% of the investigator's patient population have poorly controlled diabetes which is defined as HbA1c >9% (ADA 2019). Given high prevalence rates of uncontrolled diabetes in this high-risk population, it is pivotal that individuals are provided with appropriate diabetes self-management strategies, regular monitoring, and preventative care by their primary care provider to adequately control the disease. Numerous studies illustrate that clinical pharmacists improve health outcomes for chronic disease managements with medication therapy management (MTM) services in underserved patients. Additionally, team-based or coordinated care with the community pharmacist and the patient's health care providers has also demonstrated to assist with improvements in clinic outcomes of chronic diseases. Recently, combination of blister packaging and MTM services have been shown to improve medication adherence and clinical endpoints. Given the high prevalence of diabetes in this community, there is a critical need to achieve improvement in clinical diabetes outcomes possibly via monthly blister packaging and MTM services including point-of-care testing (POCT).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of care |
| Pharmacist Intervention | Experimental | Other: Pharmacist and pillpack intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years of age, any gender
- Hemoglobin A1c >8.5%
- Taking total of ≥5 medications and taking ≥2 anti-diabetes medications
Key exclusion criteria (2 listed)
- Unable to give informed consent
- Individuals included in Inland Empire Health Plan's Complex Care Program
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 |
|---|---|---|
| Pharmacist and pillpack interventionThese participants will be randomized into one of the following two cohorts: standard of care (SOC) and pharmacy intervention group (blister packaging + MTM services). For pharmacy intervention (PI) group, the POCT will be used to measure HbA1c and blood pressure (BP) at baseline, 3, and 6 months during medication therapy management (MTM) service. Recommendation from MTM services will be documented in the patients' electronic medical records (EMRs) and shared with their primary care providers. For the SOC group, HbA1c and BP will be measured at the physician's office and researchers will have an access to participants' EMR. | Other | Pharmacist Intervention |
| Standard of careNone. Regular visits to primary care physician. Will measure HbA1c and blood pressure at baseline, 3, and 6 months | Other | Standard of Care |
Primary outcome
hemoglobin A1c
Time frame: Change between baseline and 6 months
Finger prick for HgA1c at baseline and at 6 months. Goal < 7% normal above 7% is abnormal
blood pressure
Time frame: Change between baseline and 6 months
Blood pressure will be checked at baseline and at 6 months. Goal BP is 130/80 mmHg and above 130/80 mmHg is abnormal.
Medication adherence
Time frame: Change between baseline and 6 months
Adherence of medication will be determined by patients picking up their medications. Patient profile will track every insurance claims for the medications. The proportion of days covered indicates the medication adherence, and it will be calculated at the end of 6 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist and pillpack intervention in people with Diabetes and Medication Non Adherence, run by Loma Linda University 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 2 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: withdrawn, as of the sponsor's last update on 20 Apr 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
hemoglobin A1c (time frame: Change between baseline and 6 months). The study lists 3 primary outcomes in all. 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 20 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.