NCT06307574 · University of Arizona
bpMedManage: Digital Technology to Support Adherence to Hypertension Medications
What this study is about
The purpose of the bpMedManage study is to rigorously test the effectiveness of a smartphone technology to help improve high blood pressure medication adherence among older adults with mild cognitive impairment (MCI) in a 16-week randomly assigned controlled trial. A total of 100 older adults will be recruited.
View original scientific description
The purpose of the bpMedManage study is to rigorously test the efficacy of a smartphone technology to help improve high blood pressure medication adherence among older adults with mild cognitive impairment (MCI) in a 16-week randomized controlled trial. A total of 100 older adults will be recruited. There will be two treatment arms, bpMedManage-S and bpMedManage-P with 50 participants in each arm. Participants randomized into the bpMEDManage-S intervention arm will use a smartphone application with medication reminders plus receive education with standardized information on hypertension and antihypertensive medications on the education portal. Participants in the bpMedManage-P group will use a smartphone to receive education with standardized information on hypertension and antihypertensive medications on an education portal. Both groups will complete baseline assessments followed by 4 weeks of medication adherence monitoring. At the end of the adherence monitoring period, participants will be randomized into one of the two treatment arms. Immediate outcomes on primary and secondary measures will be assessed 4 weeks after beginning of the intervention. Follow-up outcomes will be assessed 12 weeks after the beginning of the intervention.
Interventions
BEHAVIORAL
bpMedManage
In this 16-week RCT, a total of 100 older adults with MCI will be recruited. There are two treatment arms, bpMedManage-S and bpMedManage-P with 50 participants in each arm. Participants randomized into the bpMEDManage-S intervention arm will use a smartphone application with medication reminders plus receive education with standardized information on hypertension and antihypertensive medications on the education portal. Participants in the bpMedManage-P group will use a smartphone to receive education with standardized information on hypertension and antihypertensive medications on the education portal. Both groups will complete baseline assessments followed by 4 weeks of medication adherence monitoring. At the end of the adherence monitoring period, participants will be randomized into one of the two treatment arms. Immediate outcomes will be assessed 4 weeks after beginning of the intervention. Follow-up outcomes will be assessed 12 weeks after the beginning of the intervention.
Primary outcome measures
Change in medication adherence measured by the Medication Event Monitoring System (MEMS® Cap)
Time frame: Week 4, Week 12
A device used to monitor medication adherence. The medication event monitoring system (MEMS) is a cap that fits on medication bottles and records the time and date each time the bottle is opened. Adherence data by MEMS® monitoring will be downloaded to a study laptop from all participants' MEMS® Cap via a USB connected MEMS® cap reader/communicator.
Change in self-reported medication adherence measured by the Medication Adherence Report Scale-5 (MARS-5© Professor Rob Horne)
Time frame: Week 4, Week 12
5 items on a 5-point rating scale to assess participant's medication adherence, with lower scores indicating a lower level of adherence.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Community-dwelling older adults
- Self-reported fluent in English
- Adequate self-reported visual and hearing ability
- Self-reported memory, thinking, or concentration challenges
- Self-manage at least one prescribed antihypertensive medication
- Have and use a smartphone
- No self-reported history of major depression or other mental health diagnoses
- No self-reported diagnosis of dementia or other neurological disorder such as stroke, TBI, and Parkinson's disease
- TICS-M score between 27-37 and Montreal Cognitive Assessment (MoCA) score between 20-26
- Willing to participate in the study for at least 4 months
Exclusion criteria
- Diagnosis of dementia
- Lives in assisted living facility or skilled nursing facility
Where
- Tucson, Arizona
- Champaign, Illinois
Collaborators
University of Illinois at Urbana-Champaign
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 15, 2025 · Source of record for eligibility and locations