Cardiovascular Disease
Conditions
Brief summary
For the sub-study, this digital navigation tool will both inform/educate, engage, support, and navigate participants and providers through the process of clinical trial participation via personalization (data profiling, adaptive and customized messaging, and tailored digital navigation) in a sample of 100 participants with diabetes and hypertension.
Detailed description
To identify provider- and system-level facilitators (solutions) of clinical trial participation that can be in corporated in the digital navigation tool. We will pay special emphasis on the behavior research volunteerism and altruism and individuals who are at risk for cardio metabolic conditions. To develop solutions that will address patient-, provider and system-level barriers preventing clinical trial participation Objective 2: To test the adherence, feasibility, and efficacy of a research volunteerism and altruism component of a health and wellness web app. that provides personalized newsfeeds and curriculum about research and health-related volunteer and altruistic activities versus traditional patient navigation procedures and resources in clinical trial awareness.'awareness/knowledge, attitudes, willingness to participate in clinical trial, self-efficacy, and share knowledge about clinical trial opportunities to social network. To determine which elements of the digital tool and mobil app are associated with increased awareness/knowledge, intent to participate, and contagion
Interventions
BEHAVIORALcontrol group
will receive standard medical care where research assistant will give pamphlets, with one size fits all recommendations for diet/nutrition, physical activity and sleep, to 10 subjects with comorbid HTN and T2D.
BEHAVIORALLifestyle management
Will use passive ubiquitous sensing through FitBit to 1)learn behavioral profiles of subjects who have pre-HTN/HTN and/or pre-diabetes /Diabetes 2) provide personalized recommendations through mobile based messaging app that will increase the likelihood of engaging in health diet/nutrition, physical activity and sleep practices
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* NYU and/or Bellevue patient * Diagnosed with HTN and pre-diabetes/diabetes * Must be English speakers * Ownership of a smart phone and are willing to use it to download app built in TrialX which will be free for participants * Must be ambulatory
Exclusion criteria
* are unable or unwilling to provide informed consent; * are unable to participate meaningfully in an intervention that involves self-- monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia); * are institutionalized (e.g., in a nursing home or personal care facility, or those who - are incarcerated and have limited control over self-management) * have a history of heart disease, kidney disease, or retinopathy (to rule-out those with long-standing, undiagnosed T2D)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinical trials participation Change in User Adherence | Baseline Visit, 4 week follow up visit, 6 month follow up visit | Will show that one-size-fits-all versus personalization leads to greater adherence. Adherence will be based on whether the subject met the daily and weekly behavior recommendations. |
| Change in glucose level Change in blood pressure | Baseline Visit, 4 week follow up visit, 6 month follow up visit | The amount of sugar levels will be determined the Harris-Benedict Calculator, which consists of height, weight, weight age and activity levels |
| Change in body mass index Change in blood pressure | Baseline Visit, 4 week follow up visit, 6 month follow up visit | Change in body mass index will be determined by the self reported information the vb=vodt |
| Change in physical activity | Baseline Visit, 4 week follow up visit, 6 month follow up visit | FitBit tracking will measure increase in physical activity adherence. |
| Change in physical activity by self-report | Baseline Visit, 4 week follow up visit, 6 month follow up visit | Increase in physical activity will be measured by self-report diaries collected by study staff through health and wellness app platforms. |
Countries
United States
Outcome results
None listed