HypertensionNCT01934608
The Effect of Synching Prescription Refills on Adherence
A study testing Refill synch in people with Hypertension and Hypercholesterolemia, run by University of Pennsylvania at 1 site in United States.
Trial summary
To determine the effect of synchronizing a patient's prescription refill schedule on medication adherence. The targeted population is Humana members who are currently taking 2 or more Stars medications (hypertension, hypercholesterolemia, diabetes) and are current customers of RightSource. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Hypercholesterolemia, Diabetes
- What is being tested?
- Refill synch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 691 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Nov 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Humana members who are currently taking 2 or more Stars medications (hypertension, hypercholesterolemia, diabetes) and are current customers of RightSource.
Who cannot join
- under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Test a Synchronized Prescription Refill Program to Improve Medication Adherence
To determine the effect of synchronizing a patient's prescription refill schedule on medication adherence. The targeted population is Humana members who are currently taking 2 or more Stars medications (hypertension, hypercholesterolemia, diabetes) and are current customers of RightSource. Participants will be randomized to one of two groups. Group one will be usual care and group two will be the Rx synchronization group.
- Conditions
- Hypertension, Hypercholesterolemia, Diabetes, Medication Adherence
- Being tested
- Refill synch
- Medical subject headings
- Hypertension, Hypercholesterolemia, Diabetes Mellitus, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refill synchBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Refill synch | Experimental | Participants in this group will have their medication refill schedule synchronized. Receives: Behavioral: Refill synch |
| Control | No intervention | Participants in this arm will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence to each of the chronic medications as measured by the proportion of days covered (PDC) measure
Measured: 6 months and 12 months
Secondary outcomes (1)
Secondary outcomes will be continuous gaps (e.g. 15, 30, or 60 days) in medication use.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 691 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jalpa Doshi, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934608
- Sponsor's protocol ID
- HUM-001
- Status last verified
- Dec 2015
- First submitted
- 29 Aug 2013
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Test a Synchronized Prescription Refill Program to Improve Medication Adherence
- ClinicalTrials.gov ID
- NCT01934608
- Acronym / sponsor ID
- HUM-001
- Conditions
- Hypertension, Hypercholesterolemia, Diabetes, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 691 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Sep 2013 (estimated)
- 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.
To determine the effect of synchronizing a patient's prescription refill schedule on medication adherence. The targeted population is Humana members who are currently taking 2 or more Stars medications (hypertension, hypercholesterolemia, diabetes) and are current customers of RightSource. Participants will be randomized to one of two groups. Group one will be usual care and group two will be the Rx synchronization group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Refill synch | Experimental | Behavioral: Refill synchParticipants in this group will have their medication refill schedule synchronized. |
| Control | No intervention | –Participants in this arm will receive usual care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Humana members who are currently taking 2 or more Stars medications (hypertension, hypercholesterolemia, diabetes) and are current customers of RightSource.
Key exclusion criteria (1 listed)
- under 18 years of age
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 |
|---|---|---|
| Refill synch | Behavioural | Refill synch |
Primary outcome
Medication adherence to each of the chronic medications as measured by the proportion of days covered (PDC) measure
Time frame: 6 months and 12 months
1 secondary outcome
Secondary outcomes will be continuous gaps (e.g. 15, 30, or 60 days) in medication use.
Time frame: 6 and 12 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 22 Dec 2015.
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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.
Jalpa Doshi, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Refill synch in people with Hypertension and Hypercholesterolemia, run by University of Pennsylvania 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 1 inclusion and 1 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 22 Dec 2015. 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?
Medication adherence to each of the chronic medications as measured by the proportion of days covered (PDC) measure (time frame: 6 months and 12 months). 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 22 Dec 2015.