Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06312553 |
| Other study ID # |
IRB-300012515 |
| Secondary ID |
P50MD017338 |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2024 |
| Est. completion date |
June 30, 2026 |
Study information
| Verified date |
March 2024 |
| Source |
University of Alabama at Birmingham |
| Contact |
Caroline A Presley, MD, MPH |
| Phone |
205-934-7609 |
| Email |
capresley[@]uabmc.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Diabetes distress is common affecting over one-third of people with type 2 diabetes,
negatively impacting self-management and outcomes, and disproportionately affecting
low-income individuals. The proposed project will conduct a pilot randomized controlled trial
comparing remotely delivered Mindfulness-Based Diabetes Education plus remote patient
monitoring of blood glucose to standard Diabetes Self-Management Education in rural Black
adults with type 2 diabetes and elevated diabetes distress who receive care within federally
qualified health centers to assess feasibility and acceptability.
Description:
For Aim 2, investigators will conduct a pilot randomized controlled trial (RCT) comparing
Mindfulness-Based Diabetes Education to standard Diabetes Self-Management Education in rural,
Black adults with uncontrolled type 2 diabetes and elevated diabetes distress. Pilot RCT
participants will be recruited from Federally Qualified Health Centers in the rural Black
Belt region of Alabama. Participants will be recruited through opt-out letters and phone
calls to adults with diabetes seen within the preceding two years at study sites, as well as
through in-person recruitment during clinic or through direct referral by provider or
patient.
Investigators plan to recruit up to 80 participants total, 40 per study arm. Investigators
will obtain screening consent prior to conducting screening diabetes distress and A1C (per
previously described inclusion criteria). Informed consent will be obtained from eligible
participants prior to enrollment or randomization. Participants will be randomly assigned to
receive either Mindfulness-Based Diabetes Education or standard Diabetes Self-Management
Education on a 1:1 basis; randomization will be stratified by study site and sex.
The Mindfulness-Based Diabetes Education intervention will be delivered remotely by Zoom
videoconference in 8 weekly sessions in a group setting. Following completion of the 8-week
program, participants will receive 2 bimonthly individual booster sessions by phone for a
total duration of 6 months. Mindfulness-Based Diabetes Education will be delivered by an
interventionist, who is a nurse practitioner with clinical expertise in diabetes care and
education as well as training in MBSR. During intervention sessions, participants will be
introduced to different mindfulness practices, including awareness of breath meditation, body
scan exercise, walking meditation, and mindful yoga, and informal practices including the
application of mindfulness to daily activities. Additionally, participants will receive
instruction and have opportunities to practice bringing mindful attention to specific
diabetes self-management behaviors. For example, a session will include exploration of
mind-body connections, instruction of walking meditation, educational module on physical
activity (PA), and a PA exercise with mindful attention. Participants will be asked to
complete daily home mindfulness exercises and self-monitoring of diabetes self-management
behaviors. Mindfulness-Based Diabetes Education will use incremental goal setting with
self-monitoring, feedback, and modeling to build participants' self-efficacy and on
development of social support. Sessions will include time for participants to set SMART
goals. Additionally, participants in the intervention arm will receive a glucometer and kit
to facilitate remote monitoring of blood glucose. Participants will be instructed to measure
blood glucose levels at least 1 time per day.
Standard DSME will be delivered by a Certified Diabetes Educator remotely by Zoom
videoconference in 4 biweekly, 2-hour sessions. DSME sessions will cover seven core content
areas including healthy eating, physical activity, medication usage, self-monitoring,
preventing and treating acute and chronic complications, healthy coping, and problem solving.
The primary outcomes of the study will be acceptability and feasibility. Participants in the
Mindfulness-Based Diabetes Education arm will be asked to participate in a semi-structured
interview to assess the acceptability of the intervention including participants'
perspectives on intervention content; perceived benefits or negative effects of the
intervention; appropriateness of intervention duration and frequency; satisfaction with
interventionist; satisfaction with intervention content; barriers to engagement; suggestions
to improve the intervention; and overall satisfaction. Feasibility of delivering
Mindfulness-Based Diabetes Education will be assessed through process measures including:
percentage of screened participants who are eligible; percentage of eligible participants who
enroll; ability to randomize participants to study arms; representativeness of participants
by age, gender, and race/ethnicity; number of sessions attended; participant adherence to
study tasks, including home mindfulness exercises and self-monitoring of diabetes
self-management behaviors; barriers to participation in intervention sessions or completing
study activities at home; reasons for dropping out; and overall study retention. This study
will also provide an opportunity to test the feasibility of recruitment strategies,
allocation procedures, and assessment procedures and measures.
Participants will complete assessments at baseline and 6 months, which will include an
interviewer-administered questionnaire of participant characteristics and validated measures
of stress and diabetes distress, mood, diabetes self-management behaviors, self-efficacy,
social needs, and health related-quality of life Participants will have height and weight
measured, as well as point-of-care hemoglobin A1c (A1C) testing at baseline and 6 months.
Outcome assessors will be blinded to the study arm to which participants are assigned.
