bpMedManage: Digital Technology to Support Adherence to Hypertension Medications
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: bpMedManage.
- Who it may be relevant to
- Registry conditions: Aging, Mild Cognitive Impairment, Hypertension. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Digital Technology to Support Adherence to Hypertension Medications for Older Adults With Mild Cognitive Impairment
Overview
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 edu
Primary outcome measures
- Change in medication adherence measured by the Medication Event Monitoring System (MEMS® Cap) [Time frame: Week 4, Week 12]
- 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]
Secondary outcome measures (3)
- Change in Systolic and/or Diastolic blood pressure, as measured by taking blood pressure readings [Time frame: Week 4, Week 12]
- Change in hypertension knowledge measured by the Hypertension Knowledge-Level Scale [Time frame: Week 4, Week 12]
- System Usability measured by the System Usability Scale [Time frame: Week 4, Week 12]
Eligibility criteria
Inclusion criteria
- Age 60+
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 2 centers
- University of Arizona — Tucson
- University of Illinois, Urbana-Champaign — Champaign
Publications
- Aardex Group. (n.d.). MEMS® Button Medication Event Monitoring System. https://aardexgroup.com/about-us/
- Al-Saleh S, Lee J, Rogers W, Insel K. Translation of a Successful Behavioral Intervention to a Digital Therapeutic Self-Management System for Older Adults. Ergon Des. 2024 Apr;32(2):5-13. doi: 10.1177/10648046211066409. Epub 2022 Feb 24. PMID 38487251
- Erkoc SB, Isikli B, Metintas S, Kalyoncu C. Hypertension Knowledge-Level Scale (HK-LS): a study on development, validity and reliability. Int J Environ Res Public Health. 2012 Mar;9(3):1018-29. doi: 10.3390/ijerph9031018. Epub 2012 Mar 22. PMID 22690180
- Brooke, J. (1996). SUS: A quick and dirty usability scale. Usability Evaluation in Industry, 189, 4-7.
- Chan AHY, Horne R, Hankins M, Chisari C. The Medication Adherence Report Scale: A measurement tool for eliciting patients' reports of nonadherence. Br J Clin Pharmacol. 2020 Jul;86(7):1281-1288. doi: 10.1111/bcp.14193. Epub 2020 May 18. PMID 31823381
- Insel KC, Einstein GO, Morrow DG, Koerner KM, Hepworth JT. Multifaceted Prospective Memory Intervention to Improve Medication Adherence. J Am Geriatr Soc. 2016 Mar;64(3):561-8. doi: 10.1111/jgs.14032. PMID 27000329
- Masterson Creber RM, Maurer MS, Reading M, Hiraldo G, Hickey KT, Iribarren S. Review and Analysis of Existing Mobile Phone Apps to Support Heart Failure Symptom Monitoring and Self-Care Management Using the Mobile Application Rating Scale (MARS). JMIR Mhealth Uhealth. 2016 Jun 14;4(2):e74. doi: 10.2196/mhealth.5882. PMID 27302310
Identifiers
NCT: NCT06307574 · STUDY00002804