bpMedManage: Digital Technology to Support Adherence to Hypertension Medications

Not Applicable

Recruiting

• Conditions: Hypertension; Aging; Mild Cognitive Impairment
• Interventions: Behavioral: bpMedManage

• Registration Number: NCT06307574
• Lead Sponsor: University of Arizona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-12
• Study Start: 2024-02-29
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age 60+
2. Community-dwelling older adults
3. Self-reported fluent in English
4. Adequate self-reported visual and hearing ability
5. Self-reported memory, thinking, or concentration challenges
6. Self-manage at least one prescribed antihypertensive medication
7. Have and use a smartphone
8. No self-reported history of major depression or other mental health diagnoses
9. No self-reported diagnosis of dementia or other neurological disorder such as stroke, TBI, and Parkinson's disease
10. TICS-M score between 27-37 and Montreal Cognitive Assessment (MoCA) score between 20-26
11. Willing to participate in the study for at least 4 months

Exclusion Criteria

1. Diagnosis of dementia
2. Lives in assisted living facility or skilled nursing facility

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bpMedManage-P	bpMedManage	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. They will complete immediate outcomes assessment 4 weeks after the beginning of the intervention and follow-up outcomes 12 weeks after the beginning of intervention.
bpMedManage-S	bpMedManage	Intervention group will use a smartphone application with medication reminders plus receive education with standardized information on hypertension and antihypertensive medications on the education portal. They will complete immediate outcomes assessment 4 weeks after the beginning of the intervention and follow-up outcomes 12 weeks after the beginning of intervention.

Primary Outcome Measures

Name	Time	Method
Change in self-reported medication adherence measured by the Medication Adherence Report Scale-5 (MARS-5© Professor Rob Horne)	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.
Change in medication adherence measured by the Medication Event Monitoring System (MEMS® Cap)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Systolic and/or Diastolic blood pressure, as measured by taking blood pressure readings	Week 4, Week 12	Force of blood pushing against blood vessels while the heart beats.
System Usability measured by the System Usability Scale	Week 4, Week 12	Scale (range: 0-100) measures one's perceived usability of a system, with lower scores indicating poor system usability.
Change in hypertension knowledge measured by the Hypertension Knowledge-Level Scale	Week 4, Week 12	22-items scale (range: 0-22) with items associated with hypertension, 6 sub-dimensions, and a lower composite score indicating lower knowledge on hypertension.

Trial Locations

Locations (2)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

University of Illinois, Urbana-Champaign; 🇺🇸 Champaign, Illinois, United States