Pragmatic Delivery of Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes

Diabetes Mellitus Clinical Trial

— ChargeUp  

Official title:

Fusing Rapid-cycle Testing and Adaptive Trial Designs: A Scientific Pipeline to Translate and Individualize Evidence-based Psychosocial and Behavioral Interventions in Routine Type 1 Diabetes Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06405373
• Other study ID #: 23-2228b
• Secondary ID: 12-22-ACE-18
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: September 15, 2027

Study information

• Verified date: May 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Angela Fruik, MPH, RD
• Phone: 919-962-6348
• Email: angela.fruik[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to compare two behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the initial intervention, participants will complete surveys to assess their response to the material. Participants who are determined to be "non-responders" (i.e., the Primary intervention was not effective) will be re-randomized to one of two "Supplementary" interventions, which will include individualized sessions to learn and/or practice strategies related to either the psychological or problem-solving approach.

Description:

The study will compare the effectiveness of an emotions-focused approach with a problem-solving based approach to reduce diabetes distress (DD). The investigators will enroll N=200 adults 30 years and older with type 1 diabetes (T1D) and elevated DD from a single clinical site to participate in a 12-week study. All interventions and assessments will be delivered in a pragmatic and entirely virtual format. The investigators will utilize a precision medicine trial design (Sequential Multiple Assignment Randomized Trial; SMART) to compare two evidence-based, virtual group interventions to reduce DD in adults with T1D (primary aim). The secondary aims of the study are to estimate next best steps for participants who do not respond to group-based interventions, and to estimate optimal treatments or sequences of treatments for different individuals based on their individual characteristics, including response to prior treatment.

The study includes an initial randomization to one of two 5-week Primary Interventions:

"ReCharge", an Acceptance and Commitment Therapy (ACT)-focused approach that will help to reduce the emotional burden of diabetes management; or "TakeCharge", a problem-solving focused approach that will equip participants with new skills to manage type 1 diabetes. Participants will complete a series of assessments to determine their response to the Primary Intervention. Participants who did not respond to the Primary Intervention will be re-randomized to participate in one of two Supplementary Interventions over a 5-week period, where they will have three virtual, individualized sessions for exposure and practice with either the ReCharge or TakeCharge curriculum.

The investigators will evaluate the Reach, Effectiveness, Adoption, Implementation, and Maintenance of all phases of the study. By collecting both quantitative data and key qualitative feedback from providers and participants, the investigators will be able to assess and improve the pragmatic design of these evidence-based interventions for routine integration into healthcare settings. Completion of primary and secondary aims will inform a future program which saves resources and expands the availability of guidelines-oriented care to all patients with T1D.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 15, 2027
• Est. primary completion date: September 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Adults 30 years and older

• Type 1 diabetes OR latent autoimmune diabetes in adults (LADA) clinically managed as type 1 diabetes

• Elevated diabetes distress, defined as a score >= 2.0 on the T1-DDAS core scale

• English speaking

Exclusion Criteria:

• Does not receive diabetes care at UNC Endocrinology at Eastowne

• Cannot commit to the pre-scheduled weekly, virtual sessions

• Diagnosis of any major medical or psychiatric condition that would preclude participation

• Diagnosis of dementia or other conditions that affect memory or information retention, such as cognitive impairment

• Visual or auditory impairment that would interfere with participation in a group intervention

• Receiving inpatient psychiatric treatment or history of a suicide attempt within the past 12 months at the time of enrollment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes type1
• Diabetes, Autoimmune
• Distress, Emotional

Intervention

Behavioral:
• ReCharge
ReCharge is an emotions-focused intervention that utilizes core components of Acceptance and Commitment Therapy (ACT) to address and minimize diabetes distress. This 5-week, group-based, virtual intervention will include a stepwise process to address diabetes distress and provide opportunities to practice new skills. Weekly assignments between the sessions will reinforce class material and give additional practice opportunities. Participants will be expected to interact in each session and will have opportunities to share their experiences and be engaged in discussion with the group and the facilitator.
• TakeCharge
TakeCharge is a problem-solving focused intervention that empowers participants to identify and make meaningful changes in their blood glucose management and other diabetes-related behaviors. This 5-week, group-based, virtual intervention will include a stepwise process to analyze data and resolve challenging situations surrounding diabetes management and provide opportunities to practice new skills. Weekly assignments between the sessions will reinforce class material and give additional practice opportunities. Participants will be expected to interact in each session and will have opportunities to share their experiences and be engaged in discussion with the group and the facilitator.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention Satisfaction	Satisfaction in the intervention for managing distress and type 1 diabetes will be self-reported using a 6-point Likert scale (1-6). Low satisfaction will be defined as a score <3.0.	Interim (6 weeks) and Endpoint (12 weeks)
Other	Perceived Effectiveness of the Intervention	Perceived value of the intervention for managing distress and type 1 diabetes will be self-reported using a 6-point Likert scale (1-6). Low perceived effectiveness will be defined as a score <3.0.	Interim (6 weeks) and Endpoint (12 weeks)
Other	Long-term Change in Total Diabetes Distress (T1-DDS Total Score)	Self-reported total diabetes distress will be measured using the 28-item Type 1 Diabetes Distress Scale (T1-DDS Total Score). The scale yields an overall distress score that is the average of all responses rated on a 6-point Likert scale for all 28 items (range 1-6). A score >= 2.0 is considered clinically significant diabetes distress. The primary efficacy outcomes of this study is the change in the T1D-DDS score and the proportion of individuals with a change in the T1D-DDS score at least as large as one minimally clinically important difference (MCID).	24 and 36 weeks
Other	Long-term Change in Core Diabetes Distress (T1-DDAS Core Score)	Self-reported core diabetes distress will be measured using the newer, 8-item Type 1 Diabetes Distress Assessment System (T1-DDAS Core Score). The scale yields a core distress score that is the average of all responses rated on a 5-point Likert scale for all 8 items (range 1-5). A score >= 2.0 is considered clinically significant diabetes distress.	24 and 36 weeks
Other	Long-term Change in Sources of Diabetes Distress (T1-DDS Subscale Scores)	Self-reported sources of diabetes distress will be measured using the 7 subscales of the 28-item Type 1 Diabetes Distress Scale (T1-DDS Subscale Scores). In addition to the Total Score, the T1-DDS scale also yields a score for each of 7 subscales based on the average response on all of the items in that subscale (range = 1-6). The 7 subscale scores measure sources including: Powerlessness, Management Distress, Hypoglycemia Distress, Negative Social Perceptions, Eating Distress, Physician Distress, and Friend/Family Distress. A score >= 2.0 is considered clinically significant diabetes distress for each source.	24 and 36 weeks
Other	Long-term Change in Hemoglobin A1c (HbA1c)	HbA1c (%) reflects average glucose over the past 2-3 months. Value will be assessed by standardized laboratory assay for trial baseline and endpoint. 3- and 6-mo post-Endpoint data will be extracted from the electronic medical record.	24 and 36 weeks
Other	Long-term Change in Percent of Time in Range (TIR)	For participants using personal continuous glucose monitors (CGM), the percentage of sensor values between 70-180 mg/dL will be measured using 7-14 days of retrospective data at each time-point. Change in TIR will be calculated across time-points.	24 and 36 weeks
Other	Long-term Change in Percent of Time Below Range (TBR)	For participants using personal continuous glucose monitors (CGM), the percentage of sensor values in the hypoglycemic range (<70 mg/dL) will be measured using 7-14 days of retrospective data at each time-point. Change in TBR will be calculated across time-points.	24 and 36 weeks
Other	Long-term Change in Percent of Time Above Range (TAR)	For participants using personal continuous glucose monitors (CGM), the percentage of sensor values in the hyperglycemia range (>180 mg/dL) will be measured using 7-14 days of retrospective data at each time-point. Change in TAR will be calculated across time-points.	24 and 36 weeks
Other	Long-term Glycemic Variability	For participants using personal continuous glucose monitors (CGM), glycemic variability will be assessed using the coefficient of variation (%CV). Change in %CV will be calculated across time-points.	24 and 36 weeks
Primary	Change in Total Diabetes Distress (T1-DDS Total Score)	Self-reported total diabetes distress will be measured using the 28-item Type 1 Diabetes Distress Scale (T1-DDS Total Score). The scale yields an overall distress score that is the average of all responses rated on a 6-point Likert scale for all 28 items (range 1-6). A score >= 2.0 is considered clinically significant diabetes distress. The primary efficacy outcomes of this study is the change in the T1D-DDS score and the proportion of individuals with a change in the T1D-DDS score at least as large as one minimally clinically important difference (MCID).	Baseline, Interim (6 weeks), Endpoint (12 weeks)
Secondary	Change in Core Diabetes Distress (T1-DDAS Core Score)	Self-reported core diabetes distress will be measured using the newer, 8-item Type 1 Diabetes Distress Assessment System (T1-DDAS Core Score). The scale yields a core distress score that is the average of all responses rated on a 5-point Likert scale for all 8 items (range 1-5). A score >= 2.0 is considered clinically significant diabetes distress.	Baseline, Interim (6 weeks), Endpoint (12 weeks)
Secondary	Change in Sources of Diabetes Distress (T1-DDS Subscale Scores)	Self-reported sources of diabetes distress will be measured using the 7 subscales of the 28-item Type 1 Diabetes Distress Scale (T1-DDS Subscale Scores). In addition to the Total Score, the T1-DDS scale also yields a score for each of 7 subscales based on the average response on all of the items in that subscale (range = 1-6). The 7 subscale scores measure sources including: Powerlessness, Management Distress, Hypoglycemia Distress, Negative Social Perceptions, Eating Distress, Physician Distress, and Friend/Family Distress. A score >= 2.0 is considered clinically significant diabetes distress for each source.	Baseline, Interim (6 weeks), Endpoint (12 weeks)
Secondary	Change in Perceived Stress	The Perceived Stress Scale 4 (PSS-4) is a 4-item questionnaire used to measure the degree to which situations in one's life are appraised as stressful during the last month. Respondents self-report the frequency of four key thoughts and feelings over the past month using a 5-point Likert scale. Total score is determined by adding together the scores of each of the four items (range 0-4).	Baseline, Interim (6 weeks), Endpoint (12 weeks)
Secondary	Change in Diabetes Quality of Life	The Diabetes Quality of Life (DQOL) - Brief Clinical Inventory is a 15-item questionnaire used to provide a total health-related quality of life score that predicts self-reported diabetes care behaviors and satisfaction with diabetes control. Items are scored on 5-point Likert scale under two general formats. One format asks about the frequency of negative impact of diabetes itself or of the diabetes treatment and provides response options from 1 ("Never") to 5 ("All the time"). The second format asks about satisfaction with treatment and quality of life and is scored from 1 ("Very satisfied") to 5 ("Very dissatisfied").	Baseline, Interim (6 weeks), Endpoint (12 weeks)
Secondary	Change in Perceived Confidence in Diabetes	The Perceived Competence in Diabetes Scale (PCDS) is a 4-item questionnaire used to assess the degree to which persons with diabetes feel they can manage the everyday aspects of diabetes care. Items are scored on a 1-7 Likert scale from 1 ("not at all true") to 7 ("very true"); items are averaged to form a perceived competence score (range 1-7).	Baseline, Interim (6 weeks), Endpoint (12 weeks)
Secondary	Change in Diabetes Specific Self-Compassion	The Diabetes Specific Self-Compassion (SCS-D) is a 19-item questionnaire used to assess diabetes specific self-compassion and self-buffering against negative emotions in adults with T1D. Items are scored on a 1-5 Likert scale; average scores determined by calculating the mean of subscale item responses.	Baseline, Interim (6 weeks), Endpoint (12 weeks)
Secondary	Change in Hypoglycemic Attitudes and Behaviors	The Hypoglycemic Attitudes and Behavior Scale (HABS) is a 14-item self-report scale highlighting two critical dimensions of hypoglycemia-related concerns (anxiety and avoidance) and one positive dimension (confidence). Items are scored on a 1-5 Likert scale from 1 ("Strongly Disagree") to 5 ("Strongly Agree"); Mean item scores are assessed for each hypoglycemia related dimension.	Baseline, Interim (6 weeks), Endpoint (12 weeks)
Secondary	Change in Hemoglobin A1c (HbA1c)	HbA1c (%) reflects average glucose over the past 2-3 months. Value will be assessed by standardized laboratory assay for trial baseline and endpoint. 3- and 6-mo post-Endpoint data will be extracted from the electronic medical record.	Baseline, Endpoint (12 weeks)
Secondary	Change in Percent of Time in Range (TIR)	For participants using personal continuous glucose monitors (CGM), the percentage of sensor values between 70-180 mg/dL will be measured using 7-14 days of retrospective data at each time-point. Change in TIR will be calculated across time-points.	Baseline, Endpoint (12 weeks)
Secondary	Change in Percent of Time Below Range (TBR)	For participants using personal continuous glucose monitors (CGM), the percentage of sensor values in the hypoglycemic range (<70 mg/dL) will be measured using 7-14 days of retrospective data at each time-point. Change in TBR will be calculated across time-points.	Baseline, Endpoint (12 weeks)
Secondary	Change in Percent of Time Above Range (TAR)	For participants using personal continuous glucose monitors (CGM), the percentage of sensor values in the hyperglycemia range (>180 mg/dL) will be measured using 7-14 days of retrospective data at each time-point. Change in TAR will be calculated across time-points.	Baseline, Endpoint (12 weeks)
Secondary	Glycemic Variability	For participants using personal continuous glucose monitors (CGM), glycemic variability will be assessed using the coefficient of variation (%CV). Change in %CV will be calculated across time-points.	Baseline, Endpoint (12 weeks)