Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support
Condition: Diabetes Mellitus; High Blood Pressure; High Blood Sugar; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Hyperglycemia
Study type: Interventional

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.
    

Intervention name(s): FAM ACT; I-DSMES
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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 intervention name(s): Family Support for Health Action; Individual-Focused DM Self-Management Education and Support
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Diabetes; Patient Activation; Self Management Education; Self Management Behavior; Autonomy Support; Social Support; Caregiver; Family Support; Glycemic Control