HypertensionMAPNCT05183763
Medication Adherence Program
A study testing STAR-MAP health coaching and Medication reminder tools in people with Hypertension and Medication Adherence, run by Tulane University at 5 sites in United States.
Trial summary
Randomized controlled trial testing the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence Program (STAR-MAP), a health coaching approach that aims to improve antihypertensive medication adherence, blood pressure control, and quality of life. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension, Medication Adherence, Behavior and Behavior Mechanisms
- What is being tested?
- STAR-MAP health coaching and Medication reminder tools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Mar 2022to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fully insured by Blue Cross Blue Shield of Louisiana (BCBSLA)
- continuously enrolled in BCBSLA for one year
- planning to remain a member of BCBSLA for next year
- English-speaking
- telephone access
- aged ≥40 years
Show all 12Show fewer
- diagnosis of essential hypertension (ICD-10-CM code I10)
- currently filling antihypertensive medication
- low antihypertensive medication refill (proportion of days covered (PDC) <0.8)
- low self-report adherence (4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4) score ≥1)
- uncontrolled blood pressure (BP) (systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg)
- desire to improve BP
Who cannot join
- living in a household with someone already enrolled in the study
- enrollment in another clinical trial for drug adherence or BP control
- moderate to severe cognitive impairment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Tulane Doctors Dermatology & Multispecialty Clinic
Covington, Louisiana, 70433
Tulane Doctors Heart & Vascular and Primary Care Clinic
Metairie, Louisiana, 70002
Tulane University Clinical and Translational Unit
New Orleans, Louisiana, 70112
LSU Health Sciences Shreveport Clinical Trials Office
Shreveport, Louisiana, 71101
About this study
Official title: Supporting Tailored Adaptive Change and Reinforcement for Medication Adherence Program: Randomized Trial of a Novel Approach to Improve Adherence in Older Hypertensive Women and Men
Randomized controlled trial testing the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence Program (STAR-MAP), a health coaching approach that aims to improve antihypertensive medication adherence, blood pressure control, and quality of life. Participants (n=402) >=40 years old with a diagnosis of hypertension, uncontrolled blood pressure, and low antihypertensive medication adherence will be recruited through a statewide health insurer, Blue Cross Blue Shield of Louisiana, and randomized to receive either interactive health coaching sessions with medication reminder tools (intervention) or medication reminder tools only (control) over one year. Data will be collected from participants at baseline, 6 months, 12 months, and 24 months using questionnaires, physical measurement (height, weight, blood pressure), a computer-based single-category implicit association test, and laboratory analysis of antihypertensive medication urinary metabolites.
- Being tested
- STAR-MAP health coaching, Medication reminder tools
- Medical subject headings
- Hypertension, Medication Adherence, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR-MAP health coachingBehavioural
Interactive health coaching delivered in 11 sessions over one year; focusing on using adaptive change tactics to improve medication-taking behavior
Medication reminder toolsBehavioural
Medication-taking reminder app and pillbox
| Study group | Role | What they receive |
|---|---|---|
| STAR-MAP | Experimental | Interactive health coaching sessions and medication reminder tools Receives: Behavioral: STAR-MAP health coaching; Behavioral: Medication reminder tools |
| Medication App and Reminder System Medication Adherence Program (MARS-MAP) | Active comparator | Medication reminder tools only Receives: Behavioral: Medication reminder tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in proportion with PDC >=0.8 at 12 months
Proportion of days covered (PDC) calculated from pharmacy refill data
Measured: 12 months
Secondary outcomes (8)
Difference in mean change in PDC, baseline to 12 months
Proportion of days covered (PDC) calculated from pharmacy refill data
Measured: Baseline to 12 months
Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months
Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence))
Measured: Baseline to 12 months
Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 12 months
Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence))
Measured: 12 months
Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 12 months
Adherence determined by liquid chromatography tandem mass spectrometry analysis of urinary metabolites of antihypertensive medications
Measured: Baseline to 12 months
Difference in proportion with controlled BP at 12 months
Controlled blood pressure (BP) defined as systolic BP <130 mm Hg and diastolic BP <80 mm Hg; BP measured using standardized protocol
Measured: 12 months
Difference in mean change in SBP, baseline to 12 months
Systolic blood pressure (SBP) measured using standardized protocol
Measured: Baseline to 12 months
Difference in mean change in DBP, baseline to 12 months
Diastolic blood pressure (DBP) measured using standardized protocol
Measured: Baseline to 12 months
Difference in mean change in health-related quality of life scores, baseline to 12 months
Quality of life measured using 12-item Short Form Survey (SF-12); scores for eight subscales, Mental Component Summary, and Physical Component Summary calculated and compared (minimum: 0 (worse quality of life); maximum: 100 (better quality of life))
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start7 Mar 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, Minds at Work, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Marie A Krousel-Wood, MD, MSPH, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183763
- Sponsor's protocol ID
- 2020-2221
- Other IDs
- R01HL153750
- Acronym
- MAP
- Status last verified
- Sep 2026
- First submitted
- 17 Dec 2021
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peacock E, Mohundro B, Li J, Bazzano L, Shankar A, Petty R, Kegan R, Krousel-Wood M. Supporting tailored adaptive change and reinforcement for medication adherence program (STAR-MAP): Rationale and design of a randomized controlled clinical trial. Contemp Clin Trials. 2026 Jul;166:108353. doi: 10.1016/j.cct.2026.108353. Epub 2026 May 22.
PubMed 42173438
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Tailored Adaptive Change and Reinforcement for Medication Adherence Program: Randomized Trial of a Novel Approach to Improve Adherence in Older Hypertensive Women and Men
- ClinicalTrials.gov ID
- NCT05183763
- Acronym / sponsor ID
- MAP / 2020-2221
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Ohio State University, Minds at Work, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 11 Jan 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.
Randomized controlled trial testing the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence Program (STAR-MAP), a health coaching approach that aims to improve antihypertensive medication adherence, blood pressure control, and quality of life. Participants (n=402) >=40 years old with a diagnosis of hypertension, uncontrolled blood pressure, and low antihypertensive medication adherence will be recruited through a statewide health insurer, Blue Cross Blue Shield of Louisiana, and randomized to receive either interactive health coaching sessions with medication reminder tools (intervention) or medication reminder tools only (control) over one year. Data will be collected from participants at baseline, 6 months, 12 months, and 24 months using questionnaires, physical measurement (height, weight, blood pressure), a computer-based single-category implicit association test, and laboratory analysis of antihypertensive medication urinary metabolites.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STAR-MAP | Experimental | Behavioral: STAR-MAP health coaching, Behavioral: Medication reminder toolsInteractive health coaching sessions and medication reminder tools |
| Medication App and Reminder System Medication Adherence Program (MARS-MAP) | Active comparator | Behavioral: Medication reminder toolsMedication reminder tools only |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- fully insured by Blue Cross Blue Shield of Louisiana (BCBSLA)
- continuously enrolled in BCBSLA for one year
- planning to remain a member of BCBSLA for next year
- English-speaking
- telephone access
Key exclusion criteria (3 listed)
- living in a household with someone already enrolled in the study
- enrollment in another clinical trial for drug adherence or BP control
- moderate to severe cognitive impairment
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 |
|---|---|---|
| STAR-MAP health coachingInteractive health coaching delivered in 11 sessions over one year; focusing on using adaptive change tactics to improve medication-taking behavior | Behavioural | STAR-MAP |
| Medication reminder toolsMedication-taking reminder app and pillbox | Behavioural | Medication App and Reminder System Medication Adherence Program (MARS-MAP), STAR-MAP |
Primary outcome
Difference in proportion with PDC >=0.8 at 12 months
Time frame: 12 months
Proportion of days covered (PDC) calculated from pharmacy refill data
8 secondary outcomes
Difference in mean change in PDC, baseline to 12 months
Time frame: Baseline to 12 months
Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months
Time frame: Baseline to 12 months
Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 12 months
Time frame: 12 months
Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 12 months
Time frame: Baseline to 12 months
Difference in proportion with controlled BP at 12 months
Time frame: 12 months
Difference in mean change in SBP, baseline to 12 months
Time frame: Baseline to 12 months
Difference in mean change in DBP, baseline to 12 months
Time frame: Baseline to 12 months
Difference in mean change in health-related quality of life scores, baseline to 12 months
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Derived from this study: PubMed 42173438Peacock E, Mohundro B, Li J, Bazzano L, Shankar A, Petty R, Kegan R, Krousel-Wood M. Supporting tailored adaptive change and reinforcement for medication adherence program (STAR-MAP): Rationale and design of a randomized controlled clinical trial. Contemp Clin Trials. 2026 Jul;166:108353. doi: 10.1016/j.cct.2026.108353. Epub 2026 May 22.
Related trials for Hypertension
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingPhase 2
Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
Pheochromocytoma, Paraganglioma
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.
Marie A Krousel-Wood, MD, MSPH principal investigator
Tulane University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAR-MAP health coaching and Medication reminder tools in people with Hypertension and Medication Adherence, run by Tulane University at 5 sites 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 12 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Difference in proportion with PDC >=0.8 at 12 months (time frame: 12 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 NCT05183763, 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 1 Oct 2026.