Trial Outcomes & Findings for Supporting Self-Management of Healthy Behaviors in Diabetes, Kidney Disease, and Hypertension (NCT NCT05565716)

Supporting Self-Management of Healthy Behaviors in Diabetes, Kidney Disease, and Hypertension

Composite outcome determined by participant retention rate, total number of assessments performed by participants over complete study period; Good adoption will be determined by greater than or equal to 70 percent of those retained in the study, and greater than or equal to 70 percent of those enrolled who actually used SMART-HABITS-4-Health at least one time as measured by data usage statistics.

Participants reported represent participants with good adherence, which was determined by 70% or more of the blood pressure assessments throughout the study period out of the recommended.

Determined through satisfactory score on the System Usability Scale survey (defined as a score above 68). Survey range is 0-100, with higher scores indicating more usability and acceptability.

Determined by satisfactory score on the System Usability Scale (SUS) survey (defined by a score above 68). The SUS score range is 0-100, with higher scores indicating better usability and acceptability.

Determined by inductive qualitative analysis from semi-structured interviews with study participants after the end of the pilot study. There is no a priori set up codes or scales to assess this outcome as it is purely a qualitative outcome.

Mean change in baseline blood pressure (the baseline visit BP) to mean blood pressure after 8 weeks in both arms.

Determined by change in enrollment survey and end of study survey scores on responses regarding CKD knowledge using the 28-question Kidney Knowledge Survey (KiKS). The survey score is defined as the sum of the correct responses to each survey question divided by the total number of questions, total score range (0-1). Higher scores indicate better knowledge.

Determined by change in enrollment survey and end of study survey scores on responses regarding self-efficacy using the Self-Efficacy for Managing Chronic Disease 6-Item Scale. Answers range from 1 = not at all confident to 10= totally confident. Total summary score range is 6-60, with higher summary scores indicating higher self-efficacy.

Determined by change in enrollment survey and end of study survey scores on responses regarding self-management using the Partners in Health Scale for Chronic Condition Self-Management (11 items). Answers range from 0=very good to 8= very poor for each of the 11 items. Total summary score range is 0-88, with higher summary scores indicating better self-management.

Change from baseline to end of study in disease-specific quality of life as measured by the Kidney Disease and Quality of Life 36-item survey (KDQOL-36), a validated instrument assessing health-related quality of life in individuals with kidney disease. The KDQOL-36 includes kidney disease-specific sub scales: Burden of Kidney Disease, Symptoms and Problems, and Effects of Kidney disease on Daily Life. Raw scores are transformed to T-scores, standardized to a general population reference with a mean of 50 and standard deviation of 10. For all sub-scales, higher T-scores indicate better health-related quality of life (i.e., lower symptom burden and less impact of kidney disease), while lower scores indicate worse quality of life. Scores are reported separately by each domain. A change of approximately 5 points is generally considered clinically meaningful in kidney disease populations.

Determined by the usage of SMART-HABITS-4-Health. Good maintenance will be determined by at least one access to the SMART-HABITS-4-Health portal or one BP monitor each week.

Determined by the comparison of the sex frequency (percentage) of the enrolled participants compared to sex frequency of general population with chronic kidney disease, diabetes, and with hypertension in the United States (approximately 54% female and 46% male).

Determined by the comparison of race groups (Black, White Asian, other) frequency (percentage) of the enrolled participants compared to the race frequencies of the general population with chronic kidney disease, diabetes, and with hypertension in the United States (approximately 20% for Black, 12% White, 14% Asian, and 14% Hispanic).

Qualitative reports describing adaptions that were made to the SMART-HABITS program in response to participant feedback, including descriptions of alterations that were made to the schedule of reminders and messaging content. Participant feedback data collected with field notes from verbal conversations and textual data from email and text messages.