HypertensionNCT01643473
Tailored Approaches to Improve Medication Adherence
A study testing Adherence Intervention in people with Hypertension, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to to culturally tailor a technology-based individualized adherence intervention for Black and Latino patients with uncontrolled HTN or T2DM, who are non-adherent to their medications, and determine its acceptability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Adherence Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 1 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have uncontrolled hypertension defined as BP>140/90 mmHg on at least two consecutive visits in the past year (or BP>130/80 mmHg for those with diabetes or kidney disease) and Framingham Risk Scores (FRS) >20% (or at least one CVD risk factor including hyperlipidemia or diabetes);
- Have been prescribed at least one antihypertensive or oral anti-diabetic medication;
- Self-identify as Latino or African American/Black
- Be > 18 years of age
Who cannot join
- Refuse or are unable to provide informed consent;
- Currently participate in another hypertension study; or 2 diabetes study
- Have significant psychiatric comorbidity
- Plan to discontinue care at the clinic within the next 3 months
- Vulnerable populations including adults unable to provide informed consent, pregnant women, and prisoners will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to to culturally tailor a technology-based individualized adherence intervention for Black and Latino patients with uncontrolled HTN or T2DM, who are non-adherent to their medications, and determine its acceptability.
Read the detailed description
Using a randomized controlled trial design, this study will compare the efficacy of a tailored adherence intervention (TAI) to a single patient education (PE) session, on medication adherence among 40 high-risk Black and Latino patients with uncontrolled hypertension (HTN) who are non-adherent to their prescribed antihypertensive medications. Patients randomized to the PE group will receive a single tablet delivered patient education session at the baseline visit. Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.
- Conditions
- Hypertension
- Being tested
- Adherence Intervention, Attention Control
- Keywords
- Hypertension, Latinos, Medication Adherence, Blood Pressure Control, Patient-centered, Black
- 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.
Adherence InterventionBehavioural
Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.
Attention ControlOther
Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes
| Study group | Role | What they receive |
|---|---|---|
| Attention Control | Active comparator | Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes Receives: Other: Attention Control |
| Tailored Adherence Intervention | Experimental | Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers Receives: Behavioral: Adherence Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Retaining Study Participants Through the 3 Month Trial
Feasibility is assessed as the absolute number of patients that are retained in the study once they are consented and enrolled at baseline.
Measured: 3 months
Secondary outcomes (3)
Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months
Change in mean systolic and diastolic blood pressure readings from baseline to 3 months. Systolic and diastolic blood pressure are measured in mmHg using a validated automated blood pressure monitor. The average of three readings was used as the blood pressure measurements for the baseline and 3 month study visit.
Measured: baseline and 3 months
Change From Baseline in HbA1c at 3 Months
Change in HbA1c from baseline to 3 months using a validated point-of-care device (Afinion AS100 Analyzer) at baseline and 3 months.
Measured: baseline and 3 months
Change From Baseline in Self-reported Medication Adherence at 3 Months
Medication adherence will be assessed by self-report using the validated 8-item Morisky Medication Adherence Scale. Scores range from 0-8, with higher scores indicative of better medication adherence.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startApr 2013
- Primary completion20 Feb 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Antoinette Schoenthaler, EdD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643473
- Sponsor's protocol ID
- s14-00414
- Status last verified
- Sep 2019
- First submitted
- 16 Jul 2012
- Last updated
- 26 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schoenthaler A, Leon M, Butler M, Steinhaeuser K, Wardzinski W. Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial. JMIR Mhealth Uhealth. 2020 Sep 23;8(9):e17135. doi: 10.2196/17135.
PubMed 32965230Schoenthaler A, De La Calle F, Barrios-Barrios M, Garcia A, Pitaro M, Lum A, Rosal M. A practice-based randomized controlled trial to improve medication adherence among Latinos with hypertension: study protocol for a randomized controlled trial. Trials. 2015 Jul 2;16:290. doi: 10.1186/s13063-015-0815-x.
PubMed 26134837
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Approaches to Improve Medication Adherence
- ClinicalTrials.gov ID
- NCT01643473
- Acronym / sponsor ID
- s14-00414
- Conditions
- Hypertension
- Keywords
- Hypertension, Latinos, Medication Adherence, Blood Pressure Control, Patient-centered, Black
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2013
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Posted 26 Sep 2019
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 is to to culturally tailor a technology-based individualized adherence intervention for Black and Latino patients with uncontrolled HTN or T2DM, who are non-adherent to their medications, and determine its acceptability.
Detailed description
Using a randomized controlled trial design, this study will compare the efficacy of a tailored adherence intervention (TAI) to a single patient education (PE) session, on medication adherence among 40 high-risk Black and Latino patients with uncontrolled hypertension (HTN) who are non-adherent to their prescribed antihypertensive medications. Patients randomized to the PE group will receive a single tablet delivered patient education session at the baseline visit. Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Control | Active comparator | Other: Attention ControlHealth education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes |
| Tailored Adherence Intervention | Experimental | Behavioral: Adherence InterventionTablet-based tailored adherence intervention matched to patients' most salient adherence barriers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have uncontrolled hypertension defined as BP>140/90 mmHg on at least two consecutive visits in the past year (or BP>130/80 mmHg for those with diabetes or kidney disease) and Framingham Risk Scores (FRS) >20% (or at least one CVD risk factor including hyperlipidemia or diabetes);
- Have been prescribed at least one antihypertensive or oral anti-diabetic medication;
- Self-identify as Latino or African American/Black
- Be > 18 years of age
Key exclusion criteria (5 listed)
- Refuse or are unable to provide informed consent;
- Currently participate in another hypertension study; or 2 diabetes study
- Have significant psychiatric comorbidity
- Plan to discontinue care at the clinic within the next 3 months
- Vulnerable populations including adults unable to provide informed consent, pregnant women, and prisoners will be excluded from this study.
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 InterventionPatients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles. | Behavioural | Tailored Adherence Intervention |
| Attention ControlHealth education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes | Other | Attention Control |
Primary outcome
Feasibility of Retaining Study Participants Through the 3 Month Trial
Time frame: 3 months
Feasibility is assessed as the absolute number of patients that are retained in the study once they are consented and enrolled at baseline.
3 secondary outcomes
Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months
Time frame: baseline and 3 months
Change From Baseline in HbA1c at 3 Months
Time frame: baseline and 3 months
Change From Baseline in Self-reported Medication Adherence at 3 Months
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32965230Schoenthaler A, Leon M, Butler M, Steinhaeuser K, Wardzinski W. Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial. JMIR Mhealth Uhealth. 2020 Sep 23;8(9):e17135. doi: 10.2196/17135.
- Derived from this study: PubMed 26134837Schoenthaler A, De La Calle F, Barrios-Barrios M, Garcia A, Pitaro M, Lum A, Rosal M. A practice-based randomized controlled trial to improve medication adherence among Latinos with hypertension: study protocol for a randomized controlled trial. Trials. 2015 Jul 2;16:290. doi: 10.1186/s13063-015-0815-x.
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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.
Antoinette Schoenthaler, EdD principal investigator
NYU Langone Health
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 Intervention in people with Hypertension, run by NYU Langone Health 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 26 Sep 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?
Yes. Results are posted in the registry (first posted 26 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of Retaining Study Participants Through the 3 Month Trial (time frame: 3 months). 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 NCT01643473, which also lists 2 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 26 Sep 2019.