HypertensionNCT06034301
Pill Bottle vs Reminder App
A study testing Medication Reminder App in people with Hypertension and Medication Adherence, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Current medication adherence interventions are minimally effective, which results in higher rates of morbidity and mortality for 45 million US adults who have hypertension and low adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Medication Adherence
- What is being tested?
- Medication Reminder App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to 2 May 2024
- 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
- currently be prescribed an antihypertensive medication by their doctor
- have taken antihypertensive medication for the last year
- be willing to download and use a new app on their phone for the study
- score a 34 or lower on the Hill Bone compliance scale
Who cannot join
- need assistance taking their medications
- have a severe cognitive impairment
- have a severe visual impairment that prevents them from reading notifications on their phone
- use a pillbox to take their medications
- do not use a smart phone or their smart phone does not meet the requirements for the app to be downloaded
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Feasibility of Interventions Impacting Medication Adherence
Current medication adherence interventions are minimally effective, which results in higher rates of morbidity and mortality for 45 million US adults who have hypertension and low adherence. This feasibility randomized controlled trial seeks to understand the efficacy of reminders and monitoring in the form of a mobile phone application vs usual care on medication adherence as well as the feasibility of the intervention and study procedures. This study will compare participants who use a mobile phone app that notifies them when to take their medications (intervention group) to participants who do not get assigned the app (control group) for 30 days. Medication adherence will be monitored using a Medication Event Monitoring System (MEMS) cap. Both groups will also receive the usual care, which will include giving participants a pamphlet about taking their medications. The long-term goal of this work is to improve antihypertensive medication adherence and to decrease morbidity and mortality. The objective of this application is to test the efficacy of the app based reminders and feedback. The hypothesis driving this research is that the intervention will be more effective than the usual care. The specific aims are as follows:
Read the detailed description
Current medication adherence interventions are minimally effective, which results in higher rates of morbidity and mortality for 45 million US adults who have hypertension and low adherence. This feasibility randomized controlled trial seeks to understand the efficacy of reminders and monitoring in the form of a mobile phone application vs usual care on medication adherence as well as the feasibility of the intervention and study procedures. This study will compare participants who use a mobile phone app that notifies them when to take their medications (intervention group) to participants who do not get assigned the app (control group) for 30 days. Participants will receive an electronic monitoring cap (i.e. a Medication Event Monitoring System (MEMS) cap) to monitor when they take their antihypertensive medications while they are in the study. Both groups will also receive the usual care, which will include giving participants a pamphlet about taking their medications. The long-term goal of this work is to improve antihypertensive medication adherence and to decrease morbidity and mortality. The objective of this application is to test the efficacy of the app based reminders and feedback. The hypothesis driving this research is that the intervention will be more effective than the usual care. The specific aims are as follows:
Aim 1. Compare the efficacy of the app based reminders and feedback with usual care for the primary outcome of medication adherence in 40 adults with hypertension and low adherence.
Aim 2. Conduct a robust process evaluation to guide intervention improvements, dissemination, and implementation in a diverse sample.
The hypothesis will be tested for two specific aims in 40 adults (20 control, 20 intervention) with hypertension and low adherence. For these aims, the study will be conducted as a phase II single-blind, parallel-group, randomized controlled trial with diverse adults with hypertension over 30 days. Participants will answer surveys about their demographics, knowledge about hypertension, and their medication adherence. They will then be randomized and either be given the standard of care or standard of care plus the intervention (app-based reminders and feedback). The intervention includes a brief training session on downloading and using the medication reminder app. Across arms, Participants will track their medication adherence for 30 days using the MEMS cap. After the 30 days, participants will take surveys about their adherence and knowledge about hypertension and have a brief exit interview with a member of the research team to talk about their experience and debrief them about the study.
- Conditions
- Hypertension, Medication Adherence
- Being tested
- Medication Reminder App
- Keywords
- Occupational Therapy, Medication Management
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Reminder AppDevice
If the participant is randomized to the intervention group, they will:
- receive a brief education session and be handed a flyer about the importance of medication adherence.
- get training on how to use the medication reminder app and participant will be given a user guide on how to use the app
- demonstrate their understanding on an iPad using the teach back method
- install and set up the medication reminder app on their phone
- receive a MEMS cap and be given instructions on how to use it with their blood pressure medication. Study team members will use a participant ID to log into the MEMS cap application; no identifiable information will be entered.
| Study group | Role | What they receive |
|---|---|---|
| MEMS Cap Only | No intervention | If the participant is randomized to the control group, they will: 1. receive a brief education session and be handed a flyer about the importance of medication adherence 2. receive a MEMS cap and be given instructions on how to use it with their blood pressure medication |
| Medication Reminder App + MEMS Cap | Active comparator | Intervention group that will be shown how to use the mobile phone medication reminder app and be given assistance downloading and setting it up on their personal phone. Receives: Device: Medication Reminder App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Event Monitoring System (MEMS) Cap
The Medication Event Monitoring System (MEMS) measures medication adherence over 30 days at home. In this system, an electronic cap will be placed on a bottle assigned to the participant's antihypertensive medication and records each time the medication bottle is opened. All participants will use the electronic monitoring for one antihypertensive medication taken daily.
Measured: 30 days
Exit interview
In the exit interview, participants will be asked qualitative questions about their experiences in the study and using the MEMS cap and medication reminder app. This will support a robust process evaluation to guide intervention improvements, dissemination, and implementation in a diverse sample.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start18 Sep 2023
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaclyn Schwartz, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034301
- Sponsor's protocol ID
- 202306153
- Status last verified
- Jun 2024
- First submitted
- 5 Sep 2023
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in any publications, after deidentification (text, tables, figures, and appendices).
Publications
Ahmed I, Ahmad NS, Ali S, Ali S, George A, Saleem Danish H, Uppal E, Soo J, Mobasheri MH, King D, Cox B, Darzi A. Medication Adherence Apps: Review and Content Analysis. JMIR Mhealth Uhealth. 2018 Mar 16;6(3):e62. doi: 10.2196/mhealth.6432.
PubMed 29549075Aldeer M., Javanmard M., & Martin R. P. (2018). A review of medication adherence monitoring technologies. Applied System Innovation, 1(2), 2. https://doi: 10.3390/asi1020014.
Morrissey EC, Casey M, Glynn LG, Walsh JC, Molloy GJ. Smartphone apps for improving medication adherence in hypertension: patients' perspectives. Patient Prefer Adherence. 2018 May 14;12:813-822. doi: 10.2147/PPA.S145647. eCollection 2018.
PubMed 29785096Santo K, Chow CK, Thiagalingam A, Rogers K, Chalmers J, Redfern J. MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol. BMJ Open. 2017 Oct 8;7(10):e017540. doi: 10.1136/bmjopen-2017-017540.
PubMed 28993388Santo K, Singleton A, Chow CK, Redfern J. Evaluating Reach, Acceptability, Utility, and Engagement with An App-Based Intervention to Improve Medication Adherence in Patients with Coronary Heart Disease in the MedApp-CHD Study: A Mixed-Methods Evaluation. Med Sci (Basel). 2019 Jun 4;7(6):68. doi: 10.3390/medsci7060068.
PubMed 31167489Santo K, Singleton A, Rogers K, Thiagalingam A, Chalmers J, Chow CK, Redfern J. Medication reminder applications to improve adherence in coronary heart disease: a randomised clinical trial. Heart. 2019 Feb;105(4):323-329. doi: 10.1136/heartjnl-2018-313479. Epub 2018 Aug 27.
PubMed 30150326
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Interventions Impacting Medication Adherence
- ClinicalTrials.gov ID
- NCT06034301
- Acronym / sponsor ID
- 202306153
- Conditions
- Hypertension, Medication Adherence
- Keywords
- Occupational Therapy, Medication Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 13 Sep 2023 (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.
Current medication adherence interventions are minimally effective, which results in higher rates of morbidity and mortality for 45 million US adults who have hypertension and low adherence. This feasibility randomized controlled trial seeks to understand the efficacy of reminders and monitoring in the form of a mobile phone application vs usual care on medication adherence as well as the feasibility of the intervention and study procedures. This study will compare participants who use a mobile phone app that notifies them when to take their medications (intervention group) to participants who do not get assigned the app (control group) for 30 days. Medication adherence will be monitored using a Medication Event Monitoring System (MEMS) cap. Both groups will also receive the usual care, which will include giving participants a pamphlet about taking their medications. The long-term goal of this work is to improve antihypertensive medication adherence and to decrease morbidity and mortality. The objective of this application is to test the efficacy of the app based reminders and feedback. The hypothesis driving this research is that the intervention will be more effective than the usual care. The specific aims are as follows:
Detailed description
Current medication adherence interventions are minimally effective, which results in higher rates of morbidity and mortality for 45 million US adults who have hypertension and low adherence. This feasibility randomized controlled trial seeks to understand the efficacy of reminders and monitoring in the form of a mobile phone application vs usual care on medication adherence as well as the feasibility of the intervention and study procedures. This study will compare participants who use a mobile phone app that notifies them when to take their medications (intervention group) to participants who do not get assigned the app (control group) for 30 days. Participants will receive an electronic monitoring cap (i.e. a Medication Event Monitoring System (MEMS) cap) to monitor when they take their antihypertensive medications while they are in the study. Both groups will also receive the usual care, which will include giving participants a pamphlet about taking their medications. The long-term goal of this work is to improve antihypertensive medication adherence and to decrease morbidity and mortality. The objective of this application is to test the efficacy of the app based reminders and feedback. The hypothesis driving this research is that the intervention will be more effective than the usual care. The specific aims are as follows:
Aim 1. Compare the efficacy of the app based reminders and feedback with usual care for the primary outcome of medication adherence in 40 adults with hypertension and low adherence.
Aim 2. Conduct a robust process evaluation to guide intervention improvements, dissemination, and implementation in a diverse sample.
The hypothesis will be tested for two specific aims in 40 adults (20 control, 20 intervention) with hypertension and low adherence. For these aims, the study will be conducted as a phase II single-blind, parallel-group, randomized controlled trial with diverse adults with hypertension over 30 days. Participants will answer surveys about their demographics, knowledge about hypertension, and their medication adherence. They will then be randomized and either be given the standard of care or standard of care plus the intervention (app-based reminders and feedback). The intervention includes a brief training session on downloading and using the medication reminder app. Across arms, Participants will track their medication adherence for 30 days using the MEMS cap. After the 30 days, participants will take surveys about their adherence and knowledge about hypertension and have a brief exit interview with a member of the research team to talk about their experience and debrief them about the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Feasibility randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| MEMS Cap Only | No intervention | –If the participant is randomized to the control group, they will: 1. receive a brief education session and be handed a flyer about the importance of medication adherence 2. receive a MEMS cap and be given instructions on how to use it with their blood pressure medication |
| Medication Reminder App + MEMS Cap | Active comparator | Device: Medication Reminder AppIntervention group that will be shown how to use the mobile phone medication reminder app and be given assistance downloading and setting it up on their personal phone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- currently be prescribed an antihypertensive medication by their doctor
- have taken antihypertensive medication for the last year
- be willing to download and use a new app on their phone for the study
- score a 34 or lower on the Hill Bone compliance scale
Key exclusion criteria (5 listed)
- need assistance taking their medications
- have a severe cognitive impairment
- have a severe visual impairment that prevents them from reading notifications on their phone
- use a pillbox to take their medications
- do not use a smart phone or their smart phone does not meet the requirements for the app to be downloaded
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 |
|---|---|---|
| Medication Reminder AppIf the participant is randomized to the intervention group, they will: 1. receive a brief education session and be handed a flyer about the importance of medication adherence. 2. get training on how to use the medication reminder app and participant will be given a user guide on how to use the app 3. demonstrate their understanding on an iPad using the teach back method 4. install and set up the medication reminder app on their phone 5. receive a MEMS cap and be given instructions on how to use it with their blood pressure medication. Study team members will use a participant ID to log into the MEMS cap application; no identifiable information will be entered. | Device | Medication Reminder App + MEMS Cap |
Primary outcome
Medication Event Monitoring System (MEMS) Cap
Time frame: 30 days
The Medication Event Monitoring System (MEMS) measures medication adherence over 30 days at home. In this system, an electronic cap will be placed on a bottle assigned to the participant's antihypertensive medication and records each time the medication bottle is opened. All participants will use the electronic monitoring for one antihypertensive medication taken daily.
Exit interview
Time frame: 30 days
In the exit interview, participants will be asked qualitative questions about their experiences in the study and using the MEMS cap and medication reminder app. This will support a robust process evaluation to guide intervention improvements, dissemination, and implementation in a diverse sample.
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 11 Jun 2024.
- Background: PubMed 29549075Ahmed I, Ahmad NS, Ali S, Ali S, George A, Saleem Danish H, Uppal E, Soo J, Mobasheri MH, King D, Cox B, Darzi A. Medication Adherence Apps: Review and Content Analysis. JMIR Mhealth Uhealth. 2018 Mar 16;6(3):e62. doi: 10.2196/mhealth.6432.
- BackgroundAldeer M., Javanmard M., & Martin R. P. (2018). A review of medication adherence monitoring technologies. Applied System Innovation, 1(2), 2. https://doi: 10.3390/asi1020014.
- Background: PubMed 29785096Morrissey EC, Casey M, Glynn LG, Walsh JC, Molloy GJ. Smartphone apps for improving medication adherence in hypertension: patients' perspectives. Patient Prefer Adherence. 2018 May 14;12:813-822. doi: 10.2147/PPA.S145647. eCollection 2018.
- Background: PubMed 28993388Santo K, Chow CK, Thiagalingam A, Rogers K, Chalmers J, Redfern J. MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol. BMJ Open. 2017 Oct 8;7(10):e017540. doi: 10.1136/bmjopen-2017-017540.
- Background: PubMed 31167489Santo K, Singleton A, Chow CK, Redfern J. Evaluating Reach, Acceptability, Utility, and Engagement with An App-Based Intervention to Improve Medication Adherence in Patients with Coronary Heart Disease in the MedApp-CHD Study: A Mixed-Methods Evaluation. Med Sci (Basel). 2019 Jun 4;7(6):68. doi: 10.3390/medsci7060068.
- Background: PubMed 30150326Santo K, Singleton A, Rogers K, Thiagalingam A, Chalmers J, Chow CK, Redfern J. Medication reminder applications to improve adherence in coronary heart disease: a randomised clinical trial. Heart. 2019 Feb;105(4):323-329. doi: 10.1136/heartjnl-2018-313479. Epub 2018 Aug 27.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in any publications, after deidentification (text, tables, figures, and appendices).
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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.
Jaclyn Schwartz, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Reminder App in people with Hypertension and Medication Adherence, run by Washington University School of Medicine 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 4 inclusion and 5 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 11 Jun 2024. 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 Event Monitoring System (MEMS) Cap (time frame: 30 days). 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 NCT06034301, which also lists 6 linked publications.
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 11 Jun 2024.