Medication AdherenceNCT04066010
Optimizing the Approach of Mobile Application Use to Improve Medication Adherence in Patients With Hypertension
A study testing Mobile application (BP-n-Me) in people with Medication Adherence and Hypertension, run by Mercer University.
Trial summary
The purpose of this study was to determine the effectiveness of using a custom-designed mobile application to improve blood pressure (BP) and promote adherence to antihypertensive medication regimens. This was a prospective, multicenter, randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Hypertension
- What is being tested?
- Mobile application (BP-n-Me)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Nov 2018
- 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
- Diagnosed with hypertension as evidenced by diagnosis codes or chart documentation
- Prescribed at least one antihypertensive for a minimum of three months prior to enrollment
- Have access to an Android mobile device with data capabilities
- Consent to using the application on their device
Who cannot join
- Do not read or speak English
- Unable to read and sign the informed consent or Health Insurance Privacy and Accountability Act (HIPAA) waiver
- Too ill or cognitively impaired to participate
About this study
The purpose of this study was to determine the effectiveness of using a custom-designed mobile application to improve blood pressure (BP) and promote adherence to antihypertensive medication regimens. This was a prospective, multicenter, randomized controlled trial. Patients were randomized to an intervention or control group for three months. Antihypertensive medication refill history was assessed three months before, during and three months after the study period. Continuous outcome measures investigated were systolic/diastolic BP and medication refill history, using the cumulative medication gap (CMG) score.
- Conditions
- Medication Adherence, Hypertension
- Being tested
- Mobile application (BP-n-Me)
- Medical subject headings
- Medication Adherence, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application (BP-n-Me)Other
The mobile app consisted of a series of features including (1) calendar reminders of when to take medications and the patient's antihypertensive medication regimen (2) a "Call your Pharmacist" button specific to patient's pharmacy, (3) a BP log in which the patient could enter blood pressure values that were automatically compared to goal values, (4) counseling points for lifestyle and adherence factors individually tailored to each patient and (5) lifestyle and medication adherence surveys.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Other | Mobile application intervention Receives: Other: Mobile application (BP-n-Me) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
This was assessed based on cumulative medication gap (CMG)
Measured: 6 months
Blood pressure
This was assessed by measuring the change of systolic and diastolic blood pressure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study startOct 2016
- Primary completionMay 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercer University
- Sponsor type
- University, hospital or other
- Collaborators
- Emory Healthcare, Grady Health System, Atlanta Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066010
- Sponsor's protocol ID
- H1605145
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.
PubMed 33769555
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Approach of Mobile Application Use to Improve Medication Adherence in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT04066010
- Acronym / sponsor ID
- H1605145
- Conditions
- Medication Adherence, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Mercer UniversityUniversity, hospital or other
- Collaborators
- Emory Healthcare, Grady Health System, Atlanta Medical Center
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 22 Aug 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.
The purpose of this study was to determine the effectiveness of using a custom-designed mobile application to improve blood pressure (BP) and promote adherence to antihypertensive medication regimens. This was a prospective, multicenter, randomized controlled trial. Patients were randomized to an intervention or control group for three months. Antihypertensive medication refill history was assessed three months before, during and three months after the study period. Continuous outcome measures investigated were systolic/diastolic BP and medication refill history, using the cumulative medication gap (CMG) score.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Other | Other: Mobile application (BP-n-Me)Mobile application intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age
- Diagnosed with hypertension as evidenced by diagnosis codes or chart documentation
- Prescribed at least one antihypertensive for a minimum of three months prior to enrollment
- Have access to an Android mobile device with data capabilities
- Consent to using the application on their device
Key exclusion criteria (3 listed)
- Do not read or speak English
- Unable to read and sign the informed consent or Health Insurance Privacy and Accountability Act (HIPAA) waiver
- Too ill or cognitively impaired to participate
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 |
|---|---|---|
| Mobile application (BP-n-Me)The mobile app consisted of a series of features including (1) calendar reminders of when to take medications and the patient's antihypertensive medication regimen (2) a "Call your Pharmacist" button specific to patient's pharmacy, (3) a BP log in which the patient could enter blood pressure values that were automatically compared to goal values, (4) counseling points for lifestyle and adherence factors individually tailored to each patient and (5) lifestyle and medication adherence surveys. | Other | Intervention |
Primary outcome
Medication adherence
Time frame: 6 months
This was assessed based on cumulative medication gap (CMG)
Blood pressure
Time frame: 6 months
This was assessed by measuring the change of systolic and diastolic blood pressure
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 30 Aug 2019.
- Derived from this study: PubMed 33769555Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application (BP-n-Me) in people with Medication Adherence and Hypertension, run by Mercer University.
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 5 inclusion and 3 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 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: 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?
On the ClinicalTrials.gov record for NCT04066010, which also lists 1 linked publication.
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 30 Aug 2019.