Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support

Hemoglobin A1c (HbA1c, percent) was measured via finger stick performed by a study research assistant, by a clinician as a part of the patients' regular care, or by patients via home test kit. For analysis, HbA1c first was examined graphically to understand how it changed over time. Main analyses then were conducted using linear mixed-effects models, with 12-month HbA1c values included in the models to increase the power to estimate changes over the initial 6 months. Adjusted outcome and effect estimates at 6 months were derived from linear mixed models using linear contrasts. The model was fitted using all available time points (baseline, 6 months, and 12 months) from all 222 enrollees to make efficient use of the data. Including all time points allows the model to account for individual trajectories over time, thus increasing power to detect treatment effects and reducing bias that could arise from analyzing the 6-month time point in isolation.

Time frame: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete HbA1c data at both baseline and 6-months post-baseline.

Patient diabetes distress was assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of \>=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.

Time frame: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete PAID-5 data at both baseline and 12-months post-baseline.

Patient diabetes distress was assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of \>=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.

Time frame: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete PAID-5 data at both baseline and 6-months post-baseline.

Hemoglobin A1c (HbA1c, percent) was measured through finger stick performed by a study research assistant, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit.

Time frame: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete HbA1c data at both baseline and 12-months post-baseline.

SBP was measured using an electronic, upper arm blood pressure monitor.

Time frame: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SBP data at both baseline and 12-months post-baseline.

SBP was measured using an electronic, upper arm blood pressure monitor.

Time frame: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SBP data at both baseline and 6-months post-baseline.

The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence.

Time frame: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SDSCA diet data at both baseline and 6-months post-baseline.

Support person distress about the patient's diabetes was assessed using the Problem Areas in Diabetes (PAID-5) Scale (for family members). The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of \>=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.

Time frame: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 support persons enrolled in the study. Ns represent the number of support persons who had complete PAID-5 data at both baseline and 6-months post-baseline. See comments on Statistical Analysis 1 for additional detail.

The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. Three types of medication adherence were assessed: number of days diabetes medications (non-insulin) were taken; number of days blood pressure medications were taken; number of days cholesterol medications were taken. Note that the Ns with data for these three measures are smaller than the Ns for diet and physical activity data. Differences are due to some patients not having been prescribed non-insulin diabetes, blood pressure and/or cholesterol medications.

Time frame: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 patient participants enrolled in the study. Ns represent the number of adult patients with type 2 diabetes who had complete adherence data for diabetes, blood pressure, and cholesterol medications, respectively, at both baseline and 6-months post-baseline.

The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence.

Time frame: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SDSCA physical activity data at both baseline and 6-months post-baseline.

Patient activation was assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation. Item scale locations were transformed from the original logit metric to a user-friendly 0-100 metric where 0=the lowest possible activation and 100=the highest possible activation as measured by this set of items. While the metric allows for a potential range of 0-100, the items included in the measure only covered the range from 40 (minimum) to 60 (maximum), not tapping what would be theoretically the lowest or highest ranges of the construct.

Time frame: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete patient activation data at both baseline and 6-months post-baseline.

Patient self-efficacy for managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy.

Time frame: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete self-efficacy data at both baseline and 6-months post-baseline.

Support person self-efficacy for helping the patient with managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale (adapted for support persons). The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can help patients perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy.

Time frame: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 support persons enrolled in the study. Ns represent the number of support persons who had complete self-efficacy data at both baseline and 6-months post-baseline. See comments on Statistical Analysis 1 for additional detail.

Impact of COVID on ability to manage Diabetes was assessed with a single closed-ended item: In the last six months, how have the COVID pandemic or social distancing rules affected your ability to manage your diabetes? The item is rated on a 5-point scale ranging from much harder to much easier. Due to small numbers, the variable was collapsed to 3 categories for analysis: harder/much harder, no change, easier/much easier.

Time frame: Cross-sectional at 6 months

Population: All patient participants with complete impact of COVID on diabetes management data.

Patient satisfaction with support person (SP) support for diabetes was assessed with 2\* items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses were rated on a 7-point scale ranging from 1, strongly disagree to 7 strongly agree. Responses are summed to create a total score with a range of 2 to 14. Higher numbers indicate greater satisfaction.

Time frame: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete support satisfaction data at both baseline and 6-months post-baseline.

Patient perception of support persons' (SP) supportive behaviors was assessed using the 8-item Important Other Climate Questionnaire (IOCQ) and non-supportive behaviors using 3 similarly-structured items addressing SP irritation, criticism and argumentativeness. All items are rated on a 7-point scale ranging from 0 (strongly disagree) to 6 (strongly agree), with non-supportive behavior items being reversed scored. Item responses were averaged to create a mean score with a possible range of 0 (low support) to 6 (high support).

Time frame: Baseline vs. 6 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete IOCQ data at both baseline and 6-months post-baseline.

Support person distress about the patient's diabetes was assessed using the Problem Areas in Diabetes (PAID-5) Scale (for family members). The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of \>=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.

Time frame: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 support persons enrolled in the study. Ns represent the number of enrolled support persons who had complete PAID-5 data at both baseline and 12-months post-baseline. See comments on Statistical Analysis 1 for additional detail.

The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence.

Time frame: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SDSCA diet data at both baseline and 12-months post-baseline.

The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. Three types of medication adherence were assessed: number of days diabetes medications (non-insulin) were taken; number of days blood pressure medications were taken; number of days cholesterol medications were taken. Note that the Ns with data for these three measures are smaller than the Ns for diet and physical activity data. Differences are due to patients not having been prescribed non-insulin diabetes, blood pressure and/or cholesterol medications.

Time frame: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete adherence data for diabetes, blood pressure, and cholesterol medication, respectively, at both baseline and 12-months post-baseline.

The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence.

Time frame: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete SDSCA physical activity data at both baseline and 12-months post-baseline.

Patient activation was assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation. Item scale locations were transformed from the original logit metric to a user-friendly 0-100 metric where 0=the lowest possible activation and 100=the highest possible activation as measured by this set of items. While the metric allows for a potential range of 0-100, the items included in the measure only covered the range from 40 (minimum) to 60 (maximum), not tapping what would be theoretically the lowest or highest ranges of the construct.

Time frame: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete patient activation data at both baseline and 12-months post-baseline.

Patient self-efficacy for managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy.

Time frame: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete self-efficacy data at both baseline and 12-months post-baseline.

Support person self-efficacy for helping the patient with managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale (adapted for support persons). The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can help patients perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy.

Time frame: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete self-efficacy data at both baseline and 12-months post-baseline.See comments on Statistical Analysis 1 for additional detail.

Patient satisfaction with support person (SP) support for diabetes was assessed with 2\* items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses were rated on a 7-point scale ranging from 1, strongly disagree to 7 strongly agree. Responses are summed to create a total score with a range of 2 to 14. Higher numbers indicate greater satisfaction.

Time frame: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete support satisfaction data at both baseline and 12-months post-baseline.

Patient perception of support persons' (SP) supportive behaviors was assessed using the 8-item Important Other Climate Questionnaire (IOCQ) and non-supportive behaviors using 3 similarly-structured items addressing SP irritation, criticism and argumentativeness. All items are rated on a 7-point scale ranging from 0 (strongly disagree) to 6 (strongly agree), with non-supportive behavior items being reversed scored. Item responses were averaged to create a mean score with a possible range of 0 (low support) to 6 (high support).

Time frame: Baseline vs. 12 months

Population: Analyses were Intention-to-Treat (ITT) and thus were based on data from all 222 adults with type 2 diabetes enrolled in the study. Ns represent the number of enrolled adults with type 2 diabetes who had complete IOCQ data at both baseline and 12-months post-baseline.