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

Not Applicable

Completed

Conditions: High Blood Pressure
Diabetes Mellitus
High Blood Sugar
Hypertension

Interventions: Behavioral: I-DSMES
Behavioral: FAM ACT

Registration Number: NCT03812614

Lead Sponsor: University of Pittsburgh

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 444

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.)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I-DSMES	I-DSMES	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: 1. Take part in a one-hour introductory session and review of patient's diabetes management risk assessment. 2. Be invited to 4-6 group diabetes self-management education (DSME) sessions lasting 45 min to 2 hours each. 3. 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.
FAM-ACT	FAM ACT	Patient and Support Person (dyad) will be included together as much as possible. The dyad will: 1. Take part in a one-hour introductory session and review of the patient's Diabetes Complications Risk Assessment profile. 2. Be invited to 4-6 Support Person-focused, group diabetes self-management education (DSME) sessions lasting 1-2 ½ hours each. 3. 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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Patient Glycemic Control at 6 Months	Baseline vs. 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Patient Glycemic Control at 12 Months	Baseline vs. 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.
Change From Baseline in Patient Systolic Blood Pressure at 6 Months	Baseline vs. 6 months	SBP was measured using an electronic, upper arm blood pressure monitor.
Change From Baseline in Patient Systolic Blood Pressure at 12 Months	Baseline vs. 12 months	SBP was measured using an electronic, upper arm blood pressure monitor.
Change From Baseline in Patient Diabetes Distress at 6 Months	Baseline vs. 6 months	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.
Change From Baseline in Patient Diabetes Distress at 12 Months	Baseline vs. 12 months	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.
Change From Baseline Patient Diabetes Self-care Behaviors at 6 Months: Healthy Eating	Baseline vs. 6 months	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.
Change in Diabetes Self-care Behaviors in Patient: Physical Activity	Baseline vs. 6 months	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.
Change in Diabetes Self-care Behaviors in Patient: Medication Adherence	Baseline vs. 6 months	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.
Change in Self-efficacy of Patient	Baseline vs. 6 months	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.
Change in Patient Activation in Patient	Baseline vs. 6 months	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.
Patient Perceived Overall Satisfaction With SP Support for Diabetes	Baseline vs. 6 months	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.
Patient Perception of SP Support: Supportive and Non-supportive Behaviors	Baseline vs. 6 months	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).
Impact of COVID on Ability to Manage Diabetes	Cross-sectional at 6 months	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.
Change in Diabetes Distress in Support Person	Baseline vs. 6 months	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.
Change in Self-efficacy of Support Person	Baseline vs. 6 months	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.

Trial Locations

Locations (2): University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States
Community Health and Social Services Center (CHASS)
🇺🇸
Detroit, Michigan, United States