HypertensionMASHNCT05630521
Testing Feasibility of Medication Adherence Problem Solving for Hypertension
A study testing Medication Adherence Problem Solving for Hypertension in people with Hypertension and Adherence, Medication, run by Rush University Medical Center at 1 site in United States.
Trial summary
Adherence to medications for high blood pressure is key to improving blood pressure control and reducing the impact of cardiovascular disease. This project will test the feasibility of a tailored telehealth intervention to help patients improve adherence to blood pressure medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Adherence, Medication
- What is being tested?
- Medication Adherence Problem Solving for Hypertension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2023to 25 Sep 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
- Aged ≥ 18 years at time of study entry
- Able to read, write, and converse in English
- Have an active prescription for at least one HTN medication, reporting no antihypertensive prescription changes for 30 days prior to study entry
- Have prescription drug coverage or participate in a prescription assistance program that covers medication costs.
- Diagnosis of HTN, based on self-report or confirmed through medical records, where available. (Self-reported high BP has long been shown to be strongly correlated with presence of a HTN diagnosis.22-24 Self-report combined with presence of a prescribed HTN medication ensures that only participants with HTN will be included)
- Must self-administer their own medications
- Uncontrolled BP: systolic (SBP) ≥ 130 mmHg and/or diastolic (DBP) ≥ 80 mmHg at baseline
- Nonadherent to HTN medication (Hill-Bone Medication Subscale score < 36) at screening
Who cannot join
- Acutely ill (e.g., symptoms of myocardial infarction, respiratory distress, stroke)
- Patients who have end-stage renal disease (ESRD) and/or are on dialysis
- In state of hypertensive crisis (SBP >180 and/or DBP > 120 mmHg) at the time of study screening. Any participant in hypertensive crisis will be referred to their health care provider immediately for further instruction and follow-up, per current guidelines2
- BP measurement is contraindicated on both upper extremities
- Terminal chronic illness with a life expectancy of 6 months or less
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Testing Feasibility of the Medication Adherence Problem Solving for Hypertension (MASH) Intervention to Improve Antihypertensive Medication Adherence
Adherence to medications for high blood pressure is key to improving blood pressure control and reducing the impact of cardiovascular disease. This project will test the feasibility of a tailored telehealth intervention to help patients improve adherence to blood pressure medication.
Read the detailed description
Improving rates of blood pressure (BP) control among adults with hypertension is a key step in reducing rates of myocardial infarction, stroke, and heart failure, and lowering overall mortality from cardiovascular disease. Unfortunately, over half of patients prescribed medication for hypertension do not take their medication as prescribed, leading to a high percentage of patients (45%) who are unable to reach their target BP despite being treated with antihypertensive medication. Low medication adherence has been linked with higher rates of myocardial infarction, stroke, and angina, as well as reduced life expectancy. Previously tested interventions to improve adherence to antihypertensive regimens have had limited efficacy, largely due to an underlying assumption that a single, standardized intervention approach will address all patients' reasons for nonadherence. Tailoring adherence interventions using a Managed Problem Solving approach will permit addressing each patient's reasons for nonadherence. This project will test the feasibility of the Medication Adherence Problem Solving for Hypertension (MASH) telehealth intervention, tailored to each participant's reasons for low adherence to their antihypertensive medication. The intervention is designed to assess beliefs about hypertension, beliefs about medications, and barriers to effective medication-taking We will then deliver intervention strategies to address each patient's problematic beliefs and barriers, applying the 5 steps of Managed Problem Solving. The proposed project aims are to 1) Assess the feasibility of MASH to improve antihypertensive medication adherence among adults with hypertension (HTN) by tracking recruitment, participant engagement and satisfaction with the intervention, as well as retention in the study; 2) Obtain estimates of efficacy of MASH compared to usual care on improving antihypertensive adherence as measured by electronic monitoring caps (MEMS) and lowering BP among persons with elevated BP at baseline over 12 weeks to inform future power analyses for a full-scale trial; and 3) Obtain estimates of other model parameters necessary to inform future power analyses for a full-scale intervention trial, including (a) intervention effects on targeted reasons for nonadherence (beliefs, barriers, perceived side-effects) and their subsequent association with medication adherence; (b) strength of covariate effects (e.g. education, household size, employment); and (c) the within-participant correlation between assessments. If successful, this intervention can also serve as a model for improving medication adherence in other chronic conditions and improve health outcomes for the half of patients with chronic conditions who struggle to manage their medications.
- Conditions
- Hypertension, Adherence, Medication
- Being tested
- Medication Adherence Problem Solving for Hypertension
- Keywords
- Medication adherence, Hypertension, Telehealth
- 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 Adherence Problem Solving for HypertensionBehavioural
The MASH program is a 12-week intervention containing two components: (1) four education modules on HTN causes, risks, treatment, and barriers to treatment; and (2) telehealth visits every 2 weeks with a registered nurse to deliver evidence-based managed problem solving strategies tailored on patients' responses to assessments of HTN beliefs, medication beliefs, and barriers impacting their medication adherence.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Intervention Group | Experimental | The intervention components are: 1) educational modules and 2) bi-weekly telehealth visits for managed problem solving for 12 weeks.
All intervention participants will be provided four educational modules, electronically and in print form. The modules are adapted from evidence-based materials developed by the American Heart Association, American College of Cardiology, and Centers for Disease Control and Prevention and cover (1) the causes of HTN, (2) how HTN raises risks for other chronic conditions, (3) medications for effectively managing high BP, and (4) how to manage barriers to medication adherence.
Telehealth visits will supplement and reinforce the educational modules, addressing participants' specific knowledge needs and enhancing self-efficacy. Receives: Behavioral: Medication Adherence Problem Solving for Hypertension |
| Control | No intervention | The study will use a usual-care control group. The standard of care for this patient population does not involve any type of medication adherence intervention or monitoring beyond regular clinic follow-up visits with their health care provider. Control group participants will be given printed handouts on the American Heart Association's Life's Simple 7 lifestyle changes for reducing cardiovascular risk, along with the instructions for using the MEMS cap. If control group participants ask about their antihypertensive medications during the study, they will be referred to their prescribing provider or pharmacist for any information that could not be obtained from the medication label or pharmacy packaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of patients enrolled in the study divided by number of patients invited to participate
Measured: 12 weeks
Participant engagement
The number of intervention telehealth appointments kept divided by the number scheduled per-protocol
Measured: 12 weeks
Patient satisfaction with intervention
Qualitative responses to questions about intervention delivery and content
Measured: 12 weeks
Participant retention
% of randomized participants who complete the study
Measured: 12 weeks
Secondary outcomes (2)
Antihypertensive medication adherence
Adherence to antihypertensive medications as measured by electronic monitoring caps (MEMS)
Measured: 12 weeks
Blood pressure
Resting blood pressure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start20 Feb 2023
- Primary completion25 Aug 2024
- Study completion25 Sep 2024
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.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd Ruppar, PhD, RN, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630521
- Sponsor's protocol ID
- 22031803
- Acronym
- MASH
- Status last verified
- Sep 2024
- First submitted
- 4 Nov 2022
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final research data will be made available to other investigators who wish to conduct additional analyses. Coded data will be provided in the form of an Excel spreadsheet, and a codebook with explanations of the data fields. No individually-identifiable information will be included in the shared datasets. Data will be available for other investigators once any manuscripts using the requested data are accepted for publication. Requests for data will require a data-sharing agreement outlining the specific uses of the data.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Feasibility of the Medication Adherence Problem Solving for Hypertension (MASH) Intervention to Improve Antihypertensive Medication Adherence
- ClinicalTrials.gov ID
- NCT05630521
- Acronym / sponsor ID
- MASH / 22031803
- Conditions
- Hypertension, Adherence, Medication
- Keywords
- Medication adherence, Hypertension, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 25 Aug 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 29 Nov 2022 (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.
Adherence to medications for high blood pressure is key to improving blood pressure control and reducing the impact of cardiovascular disease. This project will test the feasibility of a tailored telehealth intervention to help patients improve adherence to blood pressure medication.
Detailed description
Improving rates of blood pressure (BP) control among adults with hypertension is a key step in reducing rates of myocardial infarction, stroke, and heart failure, and lowering overall mortality from cardiovascular disease. Unfortunately, over half of patients prescribed medication for hypertension do not take their medication as prescribed, leading to a high percentage of patients (45%) who are unable to reach their target BP despite being treated with antihypertensive medication. Low medication adherence has been linked with higher rates of myocardial infarction, stroke, and angina, as well as reduced life expectancy. Previously tested interventions to improve adherence to antihypertensive regimens have had limited efficacy, largely due to an underlying assumption that a single, standardized intervention approach will address all patients' reasons for nonadherence. Tailoring adherence interventions using a Managed Problem Solving approach will permit addressing each patient's reasons for nonadherence. This project will test the feasibility of the Medication Adherence Problem Solving for Hypertension (MASH) telehealth intervention, tailored to each participant's reasons for low adherence to their antihypertensive medication. The intervention is designed to assess beliefs about hypertension, beliefs about medications, and barriers to effective medication-taking We will then deliver intervention strategies to address each patient's problematic beliefs and barriers, applying the 5 steps of Managed Problem Solving. The proposed project aims are to 1) Assess the feasibility of MASH to improve antihypertensive medication adherence among adults with hypertension (HTN) by tracking recruitment, participant engagement and satisfaction with the intervention, as well as retention in the study; 2) Obtain estimates of efficacy of MASH compared to usual care on improving antihypertensive adherence as measured by electronic monitoring caps (MEMS) and lowering BP among persons with elevated BP at baseline over 12 weeks to inform future power analyses for a full-scale trial; and 3) Obtain estimates of other model parameters necessary to inform future power analyses for a full-scale intervention trial, including (a) intervention effects on targeted reasons for nonadherence (beliefs, barriers, perceived side-effects) and their subsequent association with medication adherence; (b) strength of covariate effects (e.g. education, household size, employment); and (c) the within-participant correlation between assessments. If successful, this intervention can also serve as a model for improving medication adherence in other chronic conditions and improve health outcomes for the half of patients with chronic conditions who struggle to manage their medications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth Intervention Group | Experimental | Behavioral: Medication Adherence Problem Solving for HypertensionThe intervention components are: 1) educational modules and 2) bi-weekly telehealth visits for managed problem solving for 12 weeks. All intervention participants will be provided four educational modules, electronically and in print form. The modules are adapted from evidence-based materials developed by the American Heart Association, American College of Cardiology, and Centers for Disease Control and Prevention and cover (1) the causes of HTN, (2) how HTN raises risks for other chronic conditions, (3) medications for effectively managing high BP, and (4) how to manage barriers to medication adherence. Telehealth visits will supplement and reinforce the educational modules, addressing participants' specific knowledge needs and enhancing self-efficacy. |
| Control | No intervention | –The study will use a usual-care control group. The standard of care for this patient population does not involve any type of medication adherence intervention or monitoring beyond regular clinic follow-up visits with their health care provider. Control group participants will be given printed handouts on the American Heart Association's Life's Simple 7 lifestyle changes for reducing cardiovascular risk, along with the instructions for using the MEMS cap. If control group participants ask about their antihypertensive medications during the study, they will be referred to their prescribing provider or pharmacist for any information that could not be obtained from the medication label or pharmacy packaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥ 18 years at time of study entry
- Able to read, write, and converse in English
- Have an active prescription for at least one HTN medication, reporting no antihypertensive prescription changes for 30 days prior to study entry
- Have prescription drug coverage or participate in a prescription assistance program that covers medication costs.
- Diagnosis of HTN, based on self-report or confirmed through medical records, where available. (Self-reported high BP has long been shown to be strongly correlated with presence of a HTN diagnosis.22-24 Self-report combined with presence of a prescribed HTN medication ensures that only participants with HTN will be included)
Key exclusion criteria (5 listed)
- Acutely ill (e.g., symptoms of myocardial infarction, respiratory distress, stroke)
- Patients who have end-stage renal disease (ESRD) and/or are on dialysis
- In state of hypertensive crisis (SBP >180 and/or DBP > 120 mmHg) at the time of study screening. Any participant in hypertensive crisis will be referred to their health care provider immediately for further instruction and follow-up, per current guidelines2
- BP measurement is contraindicated on both upper extremities
- Terminal chronic illness with a life expectancy of 6 months or less
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 Adherence Problem Solving for HypertensionThe MASH program is a 12-week intervention containing two components: (1) four education modules on HTN causes, risks, treatment, and barriers to treatment; and (2) telehealth visits every 2 weeks with a registered nurse to deliver evidence-based managed problem solving strategies tailored on patients' responses to assessments of HTN beliefs, medication beliefs, and barriers impacting their medication adherence. | Behavioural | Telehealth Intervention Group |
Primary outcome
Recruitment rate
Time frame: 12 weeks
Number of patients enrolled in the study divided by number of patients invited to participate
Participant engagement
Time frame: 12 weeks
The number of intervention telehealth appointments kept divided by the number scheduled per-protocol
Patient satisfaction with intervention
Time frame: 12 weeks
Qualitative responses to questions about intervention delivery and content
Participant retention
Time frame: 12 weeks
% of randomized participants who complete the study
2 secondary outcomes
Antihypertensive medication adherence
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
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 2 Oct 2024.
- Individual participant dataSharing planned: Yes. Final research data will be made available to other investigators who wish to conduct additional analyses. Coded data will be provided in the form of an Excel spreadsheet, and a codebook with explanations of the data fields. No individually-identifiable information will be included in the shared datasets. Data will be available for other investigators once any manuscripts using the requested data are accepted for publication. Requests for data will require a data-sharing agreement outlining the specific uses of the data.
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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.
Todd Ruppar, PhD, RN principal investigator
Rush University Medical Center
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 Adherence Problem Solving for Hypertension in people with Hypertension and Adherence, Medication, run by Rush University Medical Center 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 8 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 2 Oct 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?
Recruitment rate (time frame: 12 weeks). The study lists 4 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 2 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.