Technology Coaching Intervention for Black Women With Hypertension
Condition: Uncontrolled Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Hypertension (HTN) is a global problem affecting 972 million adults and an important public
      health burden since it is the main cause of cardiovascular disease and death, and the second
      leading cause of disability. Disproportionately affected, Black women have the highest
      prevalence of HTN in the United States. This research will evaluate potential interventions
      for possible community-based strategies for controlling HTN using interactive self-care
      strategies with coaching and technology. We hypothesize that participants who receive the
      Chronic Disease Self-Management Program (CDSMP) workshop and Interactive Technology Enhanced
      Coaching (ITEC) will have lower systolic/diastolic blood pressure (BP) and better adherence
      to antihypertensive medication(s) and lifestyle recommendations (physical activity, diet, and
      weight management) post intervention compared to participants receiving self-care management
      alone.
    

Detailed description: 
      This study includes a sample of community dwelling Black women with uncontrolled HTN. All
      participants meeting study eligibility requirements will receive the Chronic Disease
      Self-Management Program (CDSMP) workshop for 6 weeks. Participants from this pool will be
      randomized to the treatment and control arm. All study participants will continue to receive
      usual care for their HTN.

      The intervention will be divided into three steps. At Step 1 for 3 months, the treatment arm
      will receive electronic monitoring (of participants' BP, weight, physical activity, food
      diary, and medication-taking) with weekly Interactive Technology Enhanced Coaching (ITEC)
      while the control arm will receive usual care with manual BP measurements monthly. At Step 2
      for three months, the treatment arm will receive electronic monitoring with ITEC biweekly,
      and the control arm will receive electronic monitoring only. At Step 3 for three months, both
      the treatment arm and the control arm will receive electronic monitoring only.

      Our sample of n=45 participants per arm (N=90 in total), will be measured (electronic
      measurements, anthropometric measurements, and data collection tools) at baseline, 3 months,
      6 months, and at 9 months post CDSMP. A hierarchical, mixed-effects repeated measures design
      will be used to analyze the data.

      The project is a two-arm randomized controlled trial with specific aims to determine whether
      the effects of CDSMP combined with ITEC will maintain BP control, attain medication
      adherence, and achieve lifestyle modifications (physical activity, diet, and weight
      management) compared to the CDSMP alone. We will test the hypothesis that:

        1. More participants in the CDSMP/ITEC arm will have controlled BP less than 130/80 at 3
           months, 6 months, and at 9 months post CDSMP, compared to participants in CDSMP alone.

        2. More participants in the CDSMP/ITEC arm will have higher levels of adherence to
           antihypertensive medication(s) at 3 months, 6 months, and at 9 months post CDSMP,
           compared to participants in the CDSMP alone.

        3. More participants in the CDSMP/ITEC arm, will have higher levels of adherence to
           lifestyle modifications (physical activity, diet, and weight management) at 3 months, 6
           months, and at 9 months post CDSMP, compared to participants in the CDSMP alone.

      Information from this study may be used to enhance self-care management, control blood
      pressure, and increase the quality of life for Black women who are burdened with the adverse
      effects of HTN and its high disability and mortality rates.
    

Intervention name(s): Interactive Technology Enhanced Coaching (ITEC); Interactive Technology-No Coaching (IT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): As participants wear the activity tracker, take their BP and weight, along with input of food intake and medication-taking, data is transmitted in real time via Bluetooth Smart technology to the Fitbit Plus dashboard. All data is tracked, analyzed, and transparently displayed for participants to view and better understand their condition, and actively engage in self-care. Staff monitor data and communicate with participants to encourage active engagement in action plans by sending tailored coaching messages (ITEC) via the Fitbit Plus dashboard to the treatment arm weekly for 3 months, and biweekly for 3 months to motivate and support (BP control, medication adherence, and lifestyle modifications). After 6 months, the treatment arm will be monitored an additional 3 months with no tailored coaching for sustainability.; After receiving usual care for 3 months, the control arm will receive the same electronic monitoring as the treatment arm and data will be captured in the same manner with the Fitbit Plus dashboard. Participants will be expected to use the information from the dashboard and the CDSMP workshop as a guide to self-care without coaching (IT). Staff will only monitor data. Control participants will not be contacted between repeated measures data collection periods, except to send reminders if they are not participating daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will test the effects of ITEC added to CDSMP on two study aims: 1) BP control, and 2) adherence to antihypertensive medication and lifestyle modifications. After baseline data collection, participants complete a 6-week CDSMP course and then are randomly assigned to either the treatment or control arm. All participants will continue to receive usual care for HTN.
The treatment group will receive ITEC and wireless tools to track activity, BP, weight, food intake, and self-report medication-taking after an orientation to Fitbit Plus (a cloud-based collaborative care platform designed to store and track data). All tools will be synced to the participants' smartphone. The treatment arm will receive weekly ITEC for 3 months, biweekly ITEC for 3 months, and then no ITEC for 3 months.
The control arm will receive usual care only with monthly BP measured manually for 3 months and then receive the same wireless tools with monitoring to track comparative data with the treatment arm.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension, Black women, self-management, coaching