Aging, Hypertension, Medication Adherence
Conditions
Brief summary
This randomized controlled trial will assess the efficacy and scalability of a blood pressure technology system intervention. The investigators will enroll 224 older adults with hypertension to identify those who are nonadherent for one hypertension medication. The participants will be randomized to one of two groups (112 per group) to use the blood pressure system for 6-months. Both groups receive information about high blood pressure and medications. One group will also receive strategies that can be used to take medications and manage blood pressure. Both groups will complete a mid-assessment at 3-months and a post-assessment at 6-months.
Interventions
OTHERBlood Pressure Technology System M
Participants will be provided the blood pressure technology system M. The study staff will teach the participants how to use the system on their personal cell phones with instruction guides. Participants will be asked to use the system for 6-months.
OTHERBlood Pressure Technology System E
Participants will be provided the blood pressure technology system E. The study staff will teach the participants how to use the system on their personal cell phones with instruction guides. Participants will be asked to use the system for 6-months.
Sponsors
University of Arizona
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
All primary and secondary outcomes completed at 3-months and 6-months are blinded.
Intervention model description
Participants will be screened and assigned to one of two groups using a blood pressure technology system.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 65 years or older * self-manage at least one hypertension medication * able to read and speak English * willing to participate in the study for six months * currently have and use an Apple iPhone * have hypertension medication adherence ≤ 90% in the last 2 weeks of the 4-week baseline monitoring period using an AARDEX MEMS® cap
Exclusion criteria
* have inadequate visual acuity (worse than 20/50 corrected near vision on Snellen test) * experience severe depression (\> 11 on Geriatric Depression Scale Short Form, GDS-15) * are at risk for cognitive impairment (\< 23 on Montreal Cognitive Assessment, MoCA) * been instructed by their healthcare provider to withhold their blood pressure medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence (MEMS Cap) | 3 months, 6 months | The Medication Event Monitoring System (MEMS®Cap) assesses objective medication adherence using the smart pill bottle cap. Digital sensors in the track cap automatically record the date and time of cap opening and upload the information to AARDEX Medication Adherence Software. Percentage of medication taken at the correct time frame. |
| Medication Adherence Report Scale (MARS-5) | 3 months, 6 months | The Medication Adherence Report Scale (MARS-5) is a 5-item self-report scale to assess medication adherence related to the frequency of not taking a prescribed dose of medication or not taking the dose prescribed. Self-report score of 5-25. Item scores are summed for a total scale score, where higher scores reflect greater medication adherence. Scale: 5=never, 4=rarely, 3=sometimes, 2=often, and 1=always. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure (SBP) | Baseline, 3-months, 6-months | The mean of two seated blood pressure readings taken at least 15 minutes apart using a validated automated device. 6-month change in mean seated systolic BP among M system users versus E system users. |
| Perceived Autonomy | Baseline, 3-months, 6-months | The Treatment Self-Regulation Questionnaire (TSRQ) assesses perceived autonomy, treatment-related motivation, and health behavior change. A 15-item questionnaire measures motivation and regulation styles that individuals employ to manage their health-related treatments or behaviors. Scale: 1=Not at all true to 7=Very true. Score 1-7 for each of the following components: TSRQ Autonomous motivation, TSRQ Introjected regulation, TSRQ External regulation, and TSRQ Amotivation. The subscales are averaged to report the mean TSRQ score. Higher numbers indicate higher autonomous motivation, controlled motivation, or amotivation. 6-month change in perceived autonomy among M system users versus E system users. |
| Perceived Competence | Baseline, 3-months, 6-months | The Perceived Competence Scale (PCS) is a 4-item questionnaire designed to measure self-perceptions of competence in different contexts (e.g., managing medications). We modified the questions to reflect blood pressure medications. Scale: 1=Not at all true to 7=Very true. Each score on the scale is summed, and a total score is reported (ranges between 4 and 28), with higher scores indicating higher perceived competence with medication adherence. 6-month change in perceived competence among M system users versus E system users. |
| Mobile Device Proficiency | Baseline, 3-months, 6-months | The Mobile Device Proficiency Questionnaire (MDPQ) assesses experience with mobile devices, comfort level, and successful use. A 16-item survey measures older adults' proficiency and comfort level in using mobile devices such as smartphones and tablets, including navigating various features and functions. Each questionnaire item is assigned a value from 1 to 5 (1 = Never Tried; 5 = Very Easily). Eight subscale scores are computed by taking the mean of the items within each respective subscale. The overall score is calculated by adding together all subscale scores. The MDPQ-16 total score ranges from 8 to 40, with higher scores reflecting greater proficiency. 6-month change in mobile device proficiency among M system users versus E system users. |
| Hypertension Knowledge Level Scale | Baseline, 6 months | The Hypertension Knowledge Level Scale (HK-LS) consists of 22 questions with 6 sub-dimensions and scores, including: HK-LS Definition \[0-2\], HK-LS Medical treatment \[0-4\], HK-LS Drug Compliance \[0-4\], HK-LS Lifestyle \[0-5\], HK-LS Diet \[0-2\], and HK-LS Complications \[0-5\]. The sub-dimension scores are summed to generate an overall score. The HK-LS Overall ranges from 0 to 22, with a higher score indicating higher knowledge about hypertension. |
Countries
United States
Participant flow
Pre-assignment details
Additional Information: The difference between the number of participants enrolled in the study and the number who started the study is because only those with hypertension medication adherence of 90% or less started the study. Data Element Definition: A 28-day adherence monitoring period after enrollment determined adherence (90% or less to receive intervention) before participant randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 74.00 years STANDARD_DEVIATION 7.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Medication adherence (MEMS Cap) | 62.76 Percentage STANDARD_DEVIATION 28.32 |
| Medication Adherence Report Scale (MARS-5) | 24.26 Score on a scale STANDARD_DEVIATION 1.28 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 124 Participants |
| Region of Enrollment United States | 134 Participants |
| Sex: Female, Male Female | 126 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 32 | 0 / 134 |
| other Total, other adverse events | 0 / 34 | 0 / 32 | 0 / 134 |
| serious Total, serious adverse events | 0 / 34 | 0 / 32 | 0 / 134 |
Outcome results
None listed