Trial Outcomes & Findings for Improving Hypertension Medication Adherence for Older Adults (NCT NCT05610059)

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.

Improving Hypertension Medication Adherence for Older Adults

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.

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.

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.

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.

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.

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.

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.