Clinical trial NCT04933851: ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes
Official title: ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Emotional Distress
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-06-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research will compare a psychological intervention ("ACT1VATE") versus diabetes self-management education and support (DSME/S; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (T1D) who are experiencing significant diabetes-related emotional distress and poor glycemic control in a real world, healthcare environment.

Detailed description: This randomized controlled trial will compare a telemedicine psychological intervention specifically designed to address diabetes distress ("ACT1VATE") versus traditional diabetes self-management education and support (DSME/S; usual care) in improving glycemic control among N=250 adults with type 1 diabetes (T1D), glycosylated hemoglobin (HbA1c) between 7.5% - 12.5% in the last 90 days, and significant diabetes distress. Capitalizing on existing and real-world processes, the electronic health record (EHR) will be used to identify eligible patients and examine primary outcomes. Participants randomized to the usual care group will be offered standard, 1:1 DSME/S delivered by a Certified Diabetes Care and Education Specialist via telemedicine format. Participants randomized to the ACT1VATE group will be offered 5 group-therapy telemedicine sessions delivered by a Behavioral Health Provider who is an integrated member of the diabetes care team. ACT1VATE is grounded in Acceptance and Commitment Therapy (ACT), which has been delivered effectively in clinics via brief format; implemented via phone and other modalities; and adapted for a wide range of chronic conditions. The primary clinical outcome, HbA1c, assessed as part of quarterly standard-of-care medical visits will be extracted from the EHR over 12 months. Changes in patient-reported behavioral (diabetes self-care) and psychosocial (emotional well-being, quality of life) outcomes will be evaluated via online surveys at baseline, month 6, and month 12. A thorough process evaluation will be conducted to establish reach, acceptability/feasibility, adoption/maintenance, and fidelity of the intervention and will integrate patient and provider perspectives. Cost-effectiveness will also be examined from the health system perspective. By maximizing integration with routine medical care for T1D in a real world, healthcare environment, results will be highly generalizable and hold great potential to inform the future of care for adults living with T1D.

Eligibility criteria: Inclusion Criteria:

* Spanish or English-speaking
* Type 1 diabetes
* Glycosylated Hemoglobin (HbA1c) 7.5% - 12.5% in last 90 days
* Screen positive for diabetes distress

Exclusion Criteria:

* Severe medical or psychological conditions that would interfere with participation based on the opinion of a provider
* Plans to move out of the San Diego area in the next 12 months
* Lack of technology capability required to complete online surveys and telemedicine visit

Primary outcomes:
measure: Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Diabetes Distress Scale
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Summary of Diabetes Self-Care Activities Survey
timeFrame: Baseline, 6 months, 12 months
measure: Generalized Anxiety Disorder Assessment
timeFrame: Baseline, 6 months, 12 months
measure: Patient Health Questionnaire-8
timeFrame: Baseline, 6 months, 12 months
measure: Perceived Stress Scale
timeFrame: Baseline, 6 months, 12 months
measure: The WHO Well-Being Index
timeFrame: Baseline, 6 months, 12 months
measure: Hypoglycemic Attitudes and Behaviors Scale
timeFrame: Baseline, 6 months, 12 months
measure: Revised Diabetes Knowledge Test
timeFrame: Baseline, 6 months, 12 months
measure: Diabetes Support and Isolation Questionnaire
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
measure: Cost-effectiveness
timeFrame: 12 months
measure: Diabetes-Specific Self Compassion Scale
timeFrame: Baseline, 6 months, 12 months
measure: Acceptance and Action Diabetes Questionnaire
timeFrame: Baseline, 6 months, 12 months
measure: Body Mass Index (BMI)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
Locations:
city: San Diego
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
Study officials:
affiliation: Scripps Whittier Diabetes Institute
name: Addie Fortmann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scripps Whittier Diabetes Institute
name: Athena Philis-Tsimikas, MD
role: PRINCIPAL_INVESTIGATOR
References: