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

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

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).

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes Mellitus; High Blood Pressure; High Blood Sugar
• Intervention / Treatment: Behavioral: FAM ACT; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 444
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48209
      • Community Health and Social Services Center (CHASS)
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FAM-ACT; 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; 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.; Other Names: Family Support for Health Action
Active Comparator: 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: 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; 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.; Other Names: Individual-Focused DM Self-Management Education and Support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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, 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.	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.	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.	Baseline vs. 12 months
Change From Baseline in Patient Diabetes Distress at 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.	Baseline vs. 6 months
Change From Baseline in Patient Diabetes Distress at 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.	Baseline vs. 12 months
Change From Baseline Patient Diabetes Self-care Behaviors at 6 Months: 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. 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.	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. 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.	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.	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.	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.	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.	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).	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.	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.	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.	Baseline vs. 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. 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.	Baseline vs. 12 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. 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.	Baseline vs. 12 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 patients not having been prescribed non-insulin diabetes, blood pressure and/or cholesterol medications.	Baseline vs. 12 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.	Baseline vs. 12 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.	Baseline vs. 12 months
Patient Perceived Overall Satisfaction With Support Person 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.	Baseline vs. 12 months
Patient Perception of Support Person 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).	Baseline vs. 12 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.	Baseline vs. 12 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.	Baseline vs. 12 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Michigan; The Community Health and Social Services Center, Inc.
• Investigators: Principal Investigator: Ann-Marie Rosland, MD,MS, University of Pittsburgh

Publications and helpful links

General Publications

• Deverts DJ, Heisler M, Kieffer EC, Piatt GA, Valbuena F, Yabes JG, Guajardo C, Ilarraza-Montalvo D, Palmisano G, Koerbel G, Rosland AM. Comparing the effectiveness of Family Support for Health Action (FAM-ACT) with traditional community health worker-led interventions to improve adult diabetes management and outcomes: study protocol for a randomized controlled trial. Trials. 2022 Oct 3;23(1):841. doi: 10.1186/s13063-022-06764-1.
• Zupa MF, Perez S, Palmisano G, Kieffer EC, Piatt GA, Valbuena FM, Deverts DJ, Yabes JG, Heisler M, Rosland AM. Changes in Self-management During the COVID-19 Pandemic Among Adults with Type 2 Diabetes at a Federally Qualified Health Center. J Immigr Minor Health. 2022 Oct;24(5):1375-1378. doi: 10.1007/s10903-022-01351-7. Epub 2022 Mar 17.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; Caregiver; Social Support; Glycemic Control; Autonomy Support; Patient Activation; Self Management Education; Self Management Behavior; Family Support
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Hypertension; Diabetes Mellitus; Hyperglycemia
• Other Study ID Numbers: STUDY20110344; R01DK116733 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study investigators will make de-identified data sets available for sharing after the trial is finished and primary analyses have been completed and published. Researchers requesting data must present an IRB-approved methodological protocol and explain the relevance of their interest in the study completed data to public health goals. Authors completing secondary analyses of the shared study data must agree to the Center for Clinical Trials and Data Coordination (CCDC) policy on data sharing and publishing. All secondary analysis authors will be expected to credit the primary investigators and mention the data source in all publications. Secondary authors will acknowledge that the data use was in accordance with CCDC protocol and the signed Data Use Agreement (DUA). The University of Pittsburgh Principal Investigator and study coordinator will not release any data until all request criteria are met and a signed Data Use Agreement is filed.
• IPD Sharing Time Frame: The data will become available beginning 6 months and ending 36 months after the primary trial results are published.
• IPD Sharing Access Criteria: All access will be thru the Center for Clinical Trials & Data Coordination (CCDC) at the University of Pittsburgh. Access will be monitored and controlled by our data center. No access will be granted until the initial requesting investigator vetting process is completed and a signed DUA is on file. All data safety plans and monitoring are listed on the CCDC website. Researchers interested in the data must sign a data use agreement (DUA) with the University of Pittsburgh, which must also be reviewed and agreed to by study partner CHASS Center Inc. No other data sharing options will be considered. The data that may be shared includes: de-identified participant data, tables, figures, appendices, analysis plan, and protocol.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No