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

University of Pittsburgh444 enrolled

Overview

The objective of this study is to compare the effectiveness of a novel program-Family Support for Health Action (FAM-ACT) - to individual patient-focused diabetes self-management education and support (I-DSMES).

FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes management for adults with diabetes (AWDs): 1. coach family supporters in regular discussions about AWDs' diabetes progress and goals that uses empathetic and autonomy-supportive communication, 2. coach family supporters in practical roles that support diabetes-specific tasks tailored to AWDs' personal goals, 3. leverage family support in the setting of other types of social support for AWDs (support from other AWDs and their family members and Community Health Workers (CHWs)) FAM-ACT will be developed and implemented in culturally-concordant ways, in partnership with the community participating in the program. Adults with type 2 diabetes and either poor glycemic or blood pressure control will be randomized together with a Support Person (a chosen adult family member or friend) to receive either FAM-ACT or more traditional CHW-led patient-focused I-DSMES over 6 months. See our published protocol (Deverts et al 2022; full citation in references section) for additional details on the protocol including any changes made after the study started.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

444

Conditions

Diabetes Mellitus High Blood Pressure High Blood Sugar Hypertension

Interventions

FAM ACTBEHAVIORAL

Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.

I-DSMESBEHAVIORAL

Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

Patient Inclusion Criteria: 1. Have a diagnosis of Type 2 diabetes 2. Most recent HbA1c done in the 3 months prior to screening phone call \>= 7.5% 3. Plan to use recruiting site for health care over the next 12 months after enrollment 4. Must be able to identify a family member or friend who is willing to be involved in their health care Patient Exclusion Criteria: 1. Diagnosis (active or prior) of Alzheimer's disease or dementia 2. Preferred language is not English or Spanish 3. Diagnosis (active or prior) of schizophrenia or other psychotic/delusional disorder in CHASS EMR Problem list as of screening call date 4. Diagnosis of gestational diabetes without any other diabetes diagnoses 5. Diagnosed with diabetes at age \< 21 years 6. Pregnant or planning to become pregnant in the next 12 months 7. Concerns that may make it difficult to participate (ongoing health issues, personal events, etc.) 8. Have a life-limiting severe illness (e.g. chronic obstructive pulmonary disease requiring oxygen) Support Person Inclusion Criteria: 1. Able to attend intervention sessions in person or remotely via online video-conferencing 2. At least 21 years old Support Person Exclusion Criteria: 1. Does not speak English or Spanish 2. Receives pay for caring for the patient 3. Has self-reported serious mental illness (schizophrenia) 4. Has a life-limiting severe illness (e.g. chronic obstructive pulmonary disease requiring oxygen) 5. Has significant cognitive impairment (Alzheimer's disease or dementia) 6. Lives in a nursing home or long-term care facility 7. Concerns that may make it difficult to participate (ongoing health issues, personal events, etc.)

Locations (2)

Community Health and Social Services Center (CHASS)

Detroit, Michigan, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Change From Baseline in Patient Glycemic Control at 6 Months

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

Secondary Outcomes

Change From Baseline in Patient Glycemic Control at 12 Months

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

Change From Baseline in Patient Systolic Blood Pressure at 6 Months

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

Time frame: Baseline vs. 6 months

Change From Baseline in Patient Systolic Blood Pressure at 12 Months

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

Time frame: Baseline vs. 12 months

Change From Baseline in Patient Diabetes Distress at 6 Months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Change From Baseline in Patient Diabetes Distress at 12 Months

Time frame: Baseline vs. 12 months

Change From Baseline Patient Diabetes Self-care Behaviors at 6 Months: Healthy Eating

Time frame: Baseline vs. 6 months

Change in Diabetes Self-care Behaviors in Patient: Physical Activity

Time frame: Baseline vs. 6 months

Change in Diabetes Self-care Behaviors in Patient: Medication Adherence

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

Change in Self-efficacy of Patient

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

Change in Patient Activation in Patient

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

Patient Perceived Overall Satisfaction With SP Support for Diabetes

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

Patient Perception of SP Support: Supportive and Non-supportive Behaviors

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

Impact of COVID on Ability to Manage Diabetes

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

Change in Diabetes Distress in Support Person

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

Change in Self-efficacy of Support Person

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