Aging, Hypertension, Mild Cognitive Impairment
Conditions
Keywords
Digital Health Intervention, Medication Adherence, Mobile Application, Mild Cognitive Impairment, Aging, Hypertension
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.
Interventions
BEHAVIORALbpMedManage
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.
Sponsors
University of Illinois at Urbana-Champaign
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
All primary and secondary outcome assessments following the intervention, Week 4, are blinded. One of the supplementary outcome measures following the intervention at Week 12, requires the assessor to know the group assignment. This outcome pertains to their experience in the intervention. The follow-up outcome assessments at Week 12 will be administered by an unblinded assessor.
Intervention model description
Participants will be screened and randomly assigned to either the bpMedManage-S or bpMedManage-P group
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Opinion Interview | Week 12 | Understand participant opinions' regarding facilitators and barriers to using the system. |
Countries
United States
Contacts
Primary ContactKathleen Insel, PhD
Backup ContactRaksha Mudar, PhD
Outcome results
None listed