Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312553
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-08
Brief Title:
Remotely Delivered Mindfulness-Based Diabetes Education
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Remotely Delivered Mindfulness-Based Diabetes Education for Rural Adults with Uncontrolled Diabetes and Elevated Distress
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 11 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 raceethnicity 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
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 11 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 raceethnicity 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50MD017338 | NIH | None | httpsreporternihgovquickSearchP50MD017338 |