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

Study Overview
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Brief Summary
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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).

Detailed Description
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FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes management for adults with diabetes (AWDs): coach family supporters in regular discussions about AWDs' diabetes progress and goals that uses empathetic and autonomy-supportive communication, coach family supporters in practical roles that support diabetes-specific tasks tailored to AWDs' personal goals, 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.

Official Title
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Comparative Effectiveness of Adding Family Supporter Training to a CHW-Led Intervention to Improve Behavioral Management of Multiple Risk Factors for Diabetes Complications

Conditions
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Diabetes Mellitus, High Blood Pressure, High Blood Sugar, Hypertension

Intervention / Treatment
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* Behavioral: FAM ACT
* Behavioral: I-DSMES


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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized comparative effectiveness trial comparing two interventions. The participants and staff delivering the interventions will not be blinded, but the data analyst will be. This trial aims to compare the effect of the FAM-ACT intervention on patients' diabetes-related health behaviors and outcomes compared to patient-focused DSME and support (I-DSMES).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FAM-ACT<br>Patient and Support Person (dyad) will be included together as much as possible. The dyad will: Take part in a one-hour introductory session and review of the patient's Diabetes Complications Risk Assessment profile. Be invited to 4-6 Support Person-focused, group diabetes self-management education (DSME) sessions lasting 1-2 ½ hours each. Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes. | Behavioral: FAM ACT<br>* 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.<br>* Other names: Family Support for Health Action;|
| Active Comparator: I-DSMES<br>This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. Patients assigned to this arm will: Take part in a one-hour introductory session and review of patient's diabetes management risk assessment. Be invited to 4-6 group diabetes self-management education (DSME) sessions lasting 45 min to 2 hours each. Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes. | Behavioral: I-DSMES<br>* 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.<br>* Other names: Individual-Focused DM Self-Management Education and Support;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in patient glycemic control at 6 months | Hemoglobin A1c (HbA1c) in % will be measured through finger stick performed by a study RA, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit. | Baseline vs. 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in patient glycemic control at 12 months | Hemoglobin A1c (HbA1c) in % will be measured through finger stick performed by a study RA, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit. | Baseline vs. 12 months | 
| Change in systolic blood pressure | SBP will be measured using an electronic, upper arm blood pressure monitor. | Baseline vs. 6 months | 
| Change in systolic blood pressure | SBP will be measured using an electronic, upper arm blood pressure monitor. | Baseline vs. 12 months | 
| Change in diabetes distress in patient | Patient diabetes distress will be 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 will be 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. | Baseline vs. 6 months | 
| Change in diabetes distress in patient | Patient diabetes distress will be 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 will be 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. | Baseline vs. 12 months | 
| Change in diabetes self-care behaviors in patient: Healthy Eating | 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. Our study will score results within each domain separately. | Baseline vs. 6 months | 
| Change in diabetes self-care behaviors in patient: Physical Activity | 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. Our study will score results within each domain separately. | 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. Our study will score results within each domain separately. | Baseline vs. 6 months | 
| Change in self-efficacy of patient | Patient self-efficacy for managing diabetes will be 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. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy. | Baseline vs. 6 months | 
| Change in patient activation in patient | Patient activation will be 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. | Baseline vs. 6 months | 
| Patient perceived overall satisfaction with SP support for diabetes | Patient satisfaction with SP support for diabetes will be assessed with o 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 will be rated on a 7-point scale ranging from strongly disagree to strongly agree. Responses are summed to create a total score with higher numbers indicating greater satisfaction. | Baseline vs. 6 months | 
| Patient perception of SP support: Supportive and non-supportive behaviors | Patient perception of SP's supportive behaviors will be 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 1 (strongly disagree) to 7 (strongly agree), with non-supportive behavior items being reversed scored. | Baseline vs. 6 months | 
| Impact of COVID on ability to manage diabetes | Impact of COVID on Ability to Manage Diabetes will be 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. | Cross-sectional at 6 months | 
| Change in diabetes distress in support person | Support person distress about the patient's diabetes will be 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 will be 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. | Baseline vs. 6 months | 
| Change in self-efficacy of support person | Support person self-efficacy for helping the patient with managing diabetes will be 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. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy. | Baseline vs. 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Patient Activation, Self Management Education, Self Management Behavior, Autonomy Support, Social Support, Caregiver, Family Support, Glycemic Control