Trial Outcomes & Findings for Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations (NCT NCT04334109)

Dyads of persons with diabetes (N=550) and family members/support persons (N=550) were recruited and enrolled in the study. However, they were not examined or analyzed as dyads; therefore, the numbers presented here represent individual participants enrolled by each participant type (persons with diabetes; family members/support persons).

Age/date of birth not captured for all family members/support persons.

A Siemens DCA Vantage analyzer was utilized to collect HbA1c from participants via finger stick blood collection (except for 12 months post-intervention and 18 months post-intervention, which was collected through medical record abstractions).

Participant height (without shoes) was collected using a stadiometer and participant weight (without shoes) was collected using a calibrated digital scale. Height and weight were used to compute a continuous measure of BMI (kilograms per square meter).

Blood pressure was measured with a digital blood pressure device with the participant seated and arm elevated to place the cuff approximately at heart height. Two blood pressure measurements were taken, waiting at least one minute between readings. The two measurements were averaged and recorded.

Blood pressure was measured with a digital blood pressure device with the participant seated and arm elevated to place the cuff approximately at heart height. Two blood pressure measurements were taken, waiting at least one minute between readings. The two measurements were averaged and recorded.

Through finger prick blood collection, point of care tests were used to collect non-fasting blood glucose.

Through finger prick blood collection, point of care tests were used to collect lipids using a commercial lipid panel kit and Cholestech LDX analyzer.

Through finger prick blood collection, point of care tests were used to collect HDL using a commercial lipid panel kit and Cholestech LDX analyzer.

Through finger prick blood collection, point of care tests were used to collect triglycerides using a commercial lipid panel kit and Cholestech LDX analyzer.

Through finger prick blood collection, point of care tests were used to collect LDL using a commercial lipid panel kit and Cholestech LDX analyzer.

The Adherence to Refills and Medications Scale for Diabetes Medicines (ARMS-D) was used to measure patient's adherence to their medications (if prescribed). The ARMS-D uses 12 items to assess self-reported adherence to diabetes medications. Item responses range from 1 (none of the time) to 4 (all of the time) and are summed to produce an overall adherence score with a possible range of 12-48, with higher scores representing more problems with medication adherence.

The Diabetes Management Self-Efficacy Scale (DMSES) was used to measure patient's confidence in managing their diabetes. The DMSES assesses self-reported confidence in managing multiple aspects of their diabetes. The item reponses range from 1 (not at all confident) to 10 (totally confident) and are averaged to generate composite scores, with higher scores indicating higher levels of self-efficacy.

The Problem Areas in Diabetes scale (PAID-5) was used to measure diabetes-related distress. The PAID-5 consists of 5 items to assess self-reported diabetes-related emotional distress, including feeling scared or depressed. Item responses range from 0 (not a problem) to 4 (serious problem) and are summed to produce an overall composite score, with a total score of 8 or higher indicating possible diabetes-related emotional distress.

The Diabetes Attitudes Wishes and Needs (DAWN2) study Impact of Diabetes Profile (DIDP) was used to measure the perceived impact of diabetes on patients' quality of life. The DIDP consists of 6 items to assess self-reported impacts on quality of life, including physical health, financial situation, and relationships with others. Item responses range from 1 (very negative impact) to 7 (very positive impact) and are reverse scored and averaged to generate composite scores, with lower scores indicating greater positive impact and higher scores indicating greater negative impact.

The Family and Friend Involvement in Adults' Diabetes (FIAD) scale was used to measure participants' perception of helpful involvement of their friends and family in managing their diabetes. Item responses range from 1 (never in the past month) to 5 (twice or more each week) and are averaged to generate composite scores for helpful family involvement, with higher scores indicating more frequent helpful involvement.

The Family and Friend Involvement in Adults' Diabetes (FIAD) scale was used to measure participants' perception of harmful involvement of their friends and family in managing their diabetes. Item responses range from 1 (never in the past month) to 5 (twice or more each week) and are averaged to generate composite scores for harmful family involvement, with higher scores indicating more frequent harmful involvement.

Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants followed a healthful eating plan over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.

Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants followed their personally tailored eating plan over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.

Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants ate five or more servings of fruits and vegetables over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.

Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants ate high fat foods such as red meat or full-fat dairy over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.

Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants participated in at least 30 minutes of continuous physical activity over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.

Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants participated in a specific exercise session (such as swimming, walking, biking) over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.

Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants tested their blood sugar over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.

Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants tested their blood sugar the number of times recommended by their healthcare provider over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.

Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants checked their feet over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.

Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed how often participants inspected the inside of their shoes over the past week. Item responses range from 0 days to 7 days, with higher scores indicating more frequent behavior (more days in the past week). Items in the SDSCA scale were analyzed separately.

Items from the Summary of Diabetes Self-Care Activities (SDSCA) were used to assess engagement in diabetes self-care behaviors over the past week. This item assessed whether participants had smoked in the past week (yes=1; no=0). Items in the SDSCA scale were analyzed separately. The mean estimates of this outcome are presented on the odds scale from logistic generalized estimating equation models.