Adherence, PatientNCT03848884
Impact of Adherence Education and Monitoring on Community Pharmacy Star Ratings and Patient Satisfaction
A study testing Adherence monitoring and education in people with Adherence, Patient, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Does monthly adherence monitoring and education by a pharmacy resident impact Kroger star ratings, compared to the current standard? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adherence, Patient
- What is being tested?
- Adherence monitoring and education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 16 Oct 2019
- 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 or older
- Patients pre-identified by Kroger analytics in ClinicalQ - Patients with PDC < 80%
- Patient taking oral diabetes medications and/or RASA medications (ACE-I, ARB, direct renin inhibitor)
Who cannot join
- Patients who are enrolled in MedSync or Autorefill program
- Patients who are lost to follow-up
- Incomplete/missing documentation of an encounter
- Prisoners, children
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Does monthly adherence monitoring and education by a pharmacy resident impact Kroger star ratings, compared to the current standard?
Read the detailed description
To evaluate if a monthly adherence monitoring and education service impacts the percent of patients adherent to oral diabetes and renin-angiotensin system antagonists (RASA) medications based on star ratings. It will also evaluate patient satisfaction of the adherence monitoring and education service, using a standard questionnaire.
- Conditions
- Adherence, Patient
- Being tested
- Adherence monitoring and education
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence monitoring and educationBehavioural
Standardized medication counseling and education combined with individual patient customized guidance and counseling - administered monthly.
| Study group | Role | What they receive |
|---|---|---|
| Adherence monitoring and education | Experimental | Not described Receives: Behavioral: Adherence monitoring and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence in oral diabetes medications determined by star ratings
Determine change in patients who are adherent to oral diabetes medications, determined by pharmacy star ratings in adherence measures; pharmacy analytics determines the star rating measure (on a scale of 1 to 5 stars, with 5 being the highest) before and after the study. A student t-test will be used to determine if there is a difference.
Measured: Baseline to 6 months
Adherence in renin-angiotensin system antagonists (RASA) medications determined by star ratings
Determine change in patients who are adherent to RASA medications, determined by pharmacy star ratings in adherence measures; pharmacy analytics determines the star rating measure (on a scale of 1 to 5 stars, with 5 being the highest) before and after the study. A student t-test will be used to determine if there is a difference.
Measured: Baseline to 6 months
Secondary outcomes (1)
Change in proportion of days covered (PDC)
Determine change in PDC after monthly follow-up on medication adherence and education; pharmacy analytics determines patient PDC in normal practice. The mean PDC for each patient at the end of the six-month study period will be compared to the baseline using a student t-test.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Mar 2019
- Primary completion16 Oct 2019
- Study completion16 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, PatientStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Venable Goode, PharmD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848884
- Sponsor's protocol ID
- HM20014333
- Status last verified
- Oct 2019
- First submitted
- 14 Feb 2019
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adherence Education and Monitoring on Community Pharmacy Star Ratings and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT03848884
- Acronym / sponsor ID
- HM20014333
- Conditions
- Adherence, Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 21 Feb 2019 (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.
Does monthly adherence monitoring and education by a pharmacy resident impact Kroger star ratings, compared to the current standard?
Detailed description
To evaluate if a monthly adherence monitoring and education service impacts the percent of patients adherent to oral diabetes and renin-angiotensin system antagonists (RASA) medications based on star ratings. It will also evaluate patient satisfaction of the adherence monitoring and education service, using a standard questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adherence monitoring and education | Experimental | Behavioral: Adherence monitoring and education |
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 or older
- Patients pre-identified by Kroger analytics in ClinicalQ - Patients with PDC < 80%
- Patient taking oral diabetes medications and/or RASA medications (ACE-I, ARB, direct renin inhibitor)
Key exclusion criteria (4 listed)
- Patients who are enrolled in MedSync or Autorefill program
- Patients who are lost to follow-up
- Incomplete/missing documentation of an encounter
- Prisoners, children
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 |
|---|---|---|
| Adherence monitoring and educationStandardized medication counseling and education combined with individual patient customized guidance and counseling - administered monthly. | Behavioural | Adherence monitoring and education |
Primary outcome
Adherence in oral diabetes medications determined by star ratings
Time frame: Baseline to 6 months
Determine change in patients who are adherent to oral diabetes medications, determined by pharmacy star ratings in adherence measures; pharmacy analytics determines the star rating measure (on a scale of 1 to 5 stars, with 5 being the highest) before and after the study. A student t-test will be used to determine if there is a difference.
Adherence in renin-angiotensin system antagonists (RASA) medications determined by star ratings
Time frame: Baseline to 6 months
Determine change in patients who are adherent to RASA medications, determined by pharmacy star ratings in adherence measures; pharmacy analytics determines the star rating measure (on a scale of 1 to 5 stars, with 5 being the highest) before and after the study. A student t-test will be used to determine if there is a difference.
1 secondary outcome
Change in proportion of days covered (PDC)
Time frame: Baseline to 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 18 Oct 2019.
- 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.
Jean-Venable Goode, PharmD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adherence monitoring and education in people with Adherence, Patient, run by Virginia Commonwealth 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 4 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 18 Oct 2019. 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?
Adherence in oral diabetes medications determined by star ratings (time frame: Baseline to 6 months). The study lists 2 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 18 Oct 2019.