Recruiting

bpMedManage

Sponsor:

University of Arizona

Code:

NCT06307574

Conditions

Aging

Mild Cognitive Impairment

Hypertension

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

bpMedManage

Study Details

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.

Conditions

Aging

Mild Cognitive Impairment

Hypertension

Study ID

NCT06307574

Start date

Feb 29, 2024

Status verified date

Oct, 2025

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: bpMedManage-S

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.

active comparator: bpMedManage-P

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.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kathleen Insel, PhD

520-626-6220insel@arizona.edu

Raksha Mudar, PhD

217-333-4718raksha@illinois.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85721

Contacts

Kathleen Insel, PhD

520-626-6220insel@arizona.edu

University of Illinois, Urbana-Champaign

Recruiting

Champaign, Illinois, United States, 61820

Contacts

Raksha Mudar, PhD

217-333-4718raksha@illinois.edu

More Information

Sponsor

University of Arizona

Last update posted

Oct 15, 2025

Last verified

Oct, 2025

Keywords

  • Digital Health Intervention
  • Medication Adherence
  • Mobile Application
  • Mild Cognitive Impairment
  • Aging
  • Hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2025-10-15.