Clinical trial NCT05195138: Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress
Official title: Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes distress
Mindfulness-based diabetes education
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Mindfulness-Based Diabetes Education to standard Diabetes Self-Management Education in adults with type 2 diabetes and elevated diabetes distress who receive care within safety-net healthcare systems in order to assess feasibility and acceptability.

Detailed description: The investigators will conduct a pilot randomized controlled trial (RCT) of Mindfulness-Based Diabetes Education (MBDE) versus standard Diabetes Self-Management Education (DSME) in adults with type 2 diabetes and moderate-severe diabetes distress who receive their care from safety-net healthcare systems. The goal of this pilot RCT will be to assess the acceptability and feasibility of MBDE; acceptability will be assessed through qualitative follow-up interviews with participants and feasibility will be assessed through process measures. The investigators will recruit up to approximately 96 participants, 48 from each site to account for potential loss to follow up of up to 20%, for the study with total study duration of 6 months. Participants will be randomized 1:1 to each study arm. This study will also serve as a pilot test for the procedures of the RCT and of measures to be used in participant assessments.

The study will be conducted at two safety-net clinics that provide care for residents of Jefferson County using a sliding scale program based on income level - Cooper Green Mercy Health Services Authority (CGMHSA) and Alabama Regional Medicine Services (ARMS). CGMHSA, an affiliate of University of Alabama at Birmingham (UAB) Health System, is Jefferson County's public safety-net health care facility. CGMHSA provides care primarily to the indigent county residents, geographically spanning most of the Birmingham metropolitan area. Ambulatory care services are provided to patients who have type 2 diabetes through Cooper Green's Primary Care Clinic and multi-disciplinary Diabetes Clinic. ARMS is a Community Health Center serving the greater Birmingham area since 1983. ARMS provides ambulatory care for adults, including primary care, diabetes self-management education classes, and behavioral health services. ARMS offers services to patients, with or without insurance, on a sliding scale fee program based on income.

Trained study staff overseen by the study PI will recruit participants from CGMHSA and ARMS through three methods. Opt-out letters will be mailed to patients seen at CGMHSA or ARMS in the preceding three years with a diagnosis of type 2 diabetes; study staff will then call potential participants to provide more information about the study and to gauge their interest in participating. The investigators will obtain a HIPAA waiver to access potential participant information from the medical record in order to generate a recruitment list. The investigators will also conduct in-person recruitment of participants at CGMHSA and ARMS, as well as direct referral of potential participants by providers or patients. Trained study personnel will obtain screening consent from potential participants prior to screening for eligibility based on inclusion and exclusion criteria, which will include assessment of diabetes distress and hemoglobin A1c (A1C) through point-of-care (POC) finger-stick sample. Study staff will then obtain informed consent from eligible participants at the time of enrollment.

Both MDBE and standard DSME study arms will be delivered in-person, in a group setting with 10-14 participants per group. MBDE will be delivered in 8 weekly group sessions followed by 2 bimonthly individual, booster sessions conducted by phone for a total duration of 6 months. MBDE will be delivered by an interventionist with a background in nursing and training as an MBSR instructor, who will receive additional training in MBDE with an emphasis on content drawn from DSME. Standard DSME will be delivered by a certified diabetes educator in eight weekly sessions of 2 hours duration. Sessions will cover seven core content areas - healthy eating, physical activity, medication usage, self-monitoring, preventing and treating acute and chronic complications, healthy coping, and problem solving.

Total study duration will be six months; a trained study staff will complete assessments of participants in both study arms at baseline, 2 months, and 6 months. Participants in both study arms will complete assessments that will be conducted by trained study personnel, including interviewer-administered questionnaire, biometric assessment (height, weight, blood pressure), and POC A1C testing from a finger-stick sample at 3 time points - baseline, 2 months, and 6 months. Participants in the MBDE arm will be asked to participate in a focus group (estimated length 1 hour) at the 2 month time point. Participants will receive an incentive for their participation for each study assessment and for participation in a focus group.

Eligibility criteria: Inclusion Criteria:

1. Age 19-70 years
2. Diagnosis of type 2 diabetes (based on the presence of two or more outpatient International Classification of Diseases (ICD-10) codes for type 2 diabetes
3. Receipt of care at Cooper Green Mercy Health Systems Authority or Alabama Regional Medical Services (one or more visits to primary care or diabetes clinic within the prior year
4. Presence of moderate-severe diabetes distress (score ≥2 on Diabetes Distress Scale
5. Suboptimal glycemic control (elevated hemoglobin A1c (A1C) ≥7.5%)

Exclusion Criteria:

1. Non-English speaking
2. Currently pregnant
3. Diagnosis of severe psychiatric comorbidity including bipolar disorder, schizophrenia, or a history of psychosis (based on participant self-report)

Primary outcomes:
measure: Participant assessment of perceived positive and negative effects
timeFrame: 2 months
measure: Participant assessment of intervention content
timeFrame: 2 months
measure: Participant assessment of appropriateness of intervention duration and frequency
timeFrame: 2 months
measure: Participant satisfaction with interventionist
timeFrame: 2 months
measure: Participant-reported barriers to engagement with the intervention sessions or content
timeFrame: 2 months
measure: Participants' suggestions to improve the intervention
timeFrame: 2 months
measure: Participants' overall satisfaction with the intervention
timeFrame: 2 months
measure: Feasibility: percentage of screened participants who are eligible
timeFrame: 6 months
measure: Feasibility: percentage of eligible participants who enroll
timeFrame: 6 months
measure: Feasibility: ability to randomize participants to study arms
timeFrame: 6 months
measure: Feasibility: distribution of participants by demographics
timeFrame: 6 months
measure: Feasibility: percentage of sessions attended
timeFrame: 6 months
measure: Feasibility: participant adherence to study tasks include home mindfulness practices, self-monitoring activities
timeFrame: 6 months
measure: Feasibility: barriers to participation in intervention sessions or completing study activities at home
timeFrame: 6 months
measure: Feasibility: reasons for dropping out
timeFrame: 6 months
measure: Feasibility: overall study retention
timeFrame: 6 months
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: Baseline
measure: Hemoglobin A1c
timeFrame: 6 months
measure: Diabetes distress
timeFrame: Baseline
measure: Diabetes distress
timeFrame: 2 months
measure: Diabetes distress
timeFrame: 6 months
measure: Diabetes self-management behaviors
timeFrame: Baseline
measure: Diabetes self-management behaviors
timeFrame: 2 months
measure: Diabetes self-management behaviors
timeFrame: 6 months
measure: Medication adherence
timeFrame: Baseline
measure: Medication adherence
timeFrame: 2 months
measure: Medication adherence
timeFrame: 6 months
measure: Mindfulness
timeFrame: Baseline
measure: Mindfulness
timeFrame: 2 months
measure: Mindfulness
timeFrame: 6 months
measure: Emotion regulation
timeFrame: Baseline
measure: Emotion regulation
timeFrame: 2 months
measure: Emotion regulation
timeFrame: 6 months
measure: Self-awareness
timeFrame: Baseline
measure: Self-awareness
timeFrame: 2 months
measure: Self-awareness
timeFrame: 6 months
measure: Self-efficacy as assessed by the Perceived Diabetes Self-Management Scale (PDSMS)
timeFrame: Baseline
measure: Self-efficacy as assessed by the Perceived Diabetes Self-Management Scale (PDSMS)
timeFrame: 2 months
measure: Self-efficacy as assessed by the Perceived Diabetes Self-Management Scale (PDSMS)
timeFrame: 6 months
measure: Social support
timeFrame: Baseline
measure: Social support
timeFrame: 2 months
measure: Social support
timeFrame: 6 months
measure: Perceived stress
timeFrame: Baseline
measure: Perceived stress
timeFrame: 2 months
measure: Perceived stress
timeFrame: 6 months
measure: Depressive symptoms
timeFrame: Baseline
measure: Depressive symptoms
timeFrame: 2 months
measure: Depressive symptoms
timeFrame: 6 months
measure: Anxiety
timeFrame: Baseline
measure: Anxiety
timeFrame: 2 months
measure: Anxiety
timeFrame: 6 months
measure: Type 2 diabetes stigma
timeFrame: Baseline
measure: Type 2 diabetes stigma
timeFrame: 2 months
measure: Type 2 diabetes stigma
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cooper Green Mercy Health Systems
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Caroline A Presley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: