Clinical trial NCT03812614: Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support
Official title: Comparative Effectiveness of Adding Family Supporter Training to a CHW-Led Intervention to Improve Behavioral Management of Multiple Risk Factors for Diabetes Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
High Blood Pressure
High Blood Sugar
Hypertension
Keywords: Diabetes
Patient Activation
Self Management Education
Self Management Behavior
Autonomy Support
Social Support
Caregiver
Family Support
Glycemic Control
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: The Community Health and Social Services Center, Inc.
name: University of Michigan
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-01-23
Enrollment: 444
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Change From Baseline in Patient Glycemic Control at 6 Months
timeFrame: Baseline vs. 6 months
Secondary outcomes:
measure: Change From Baseline in Patient Glycemic Control at 12 Months
timeFrame: Baseline vs. 12 months
measure: Change From Baseline in Patient Systolic Blood Pressure at 6 Months
timeFrame: Baseline vs. 6 months
measure: Change From Baseline in Patient Systolic Blood Pressure at 12 Months
timeFrame: Baseline vs. 12 months
measure: Change From Baseline in Patient Diabetes Distress at 6 Months
timeFrame: Baseline vs. 6 months
measure: Change From Baseline in Patient Diabetes Distress at 12 Months
timeFrame: Baseline vs. 12 months
measure: Change From Baseline Patient Diabetes Self-care Behaviors at 6 Months: Healthy Eating
timeFrame: Baseline vs. 6 months
measure: Change in Diabetes Self-care Behaviors in Patient: Physical Activity
timeFrame: Baseline vs. 6 months
measure: Change in Diabetes Self-care Behaviors in Patient: Medication Adherence
timeFrame: Baseline vs. 6 months
measure: Change in Self-efficacy of Patient
timeFrame: Baseline vs. 6 months
measure: Change in Patient Activation in Patient
timeFrame: Baseline vs. 6 months
measure: Patient Perceived Overall Satisfaction With SP Support for Diabetes
timeFrame: Baseline vs. 6 months
measure: Patient Perception of SP Support: Supportive and Non-supportive Behaviors
timeFrame: Baseline vs. 6 months
measure: Impact of COVID on Ability to Manage Diabetes
timeFrame: Cross-sectional at 6 months
measure: Change in Diabetes Distress in Support Person
timeFrame: Baseline vs. 6 months
measure: Change in Self-efficacy of Support Person
timeFrame: Baseline vs. 6 months
Other outcomes:
measure: Change in Diabetes Self-care Behaviors in Patient: Healthy Eating
timeFrame: Baseline vs. 12 months
measure: Change in Diabetes Self-care Behaviors in Patient: Physical Activity
timeFrame: Baseline vs. 12 months
measure: Change in Diabetes Self-care Behaviors in Patient: Medication Adherence
timeFrame: Baseline vs. 12 months
measure: Change in Self-efficacy of Patient
timeFrame: Baseline vs. 12 months
measure: Change in Patient Activation in Patient
timeFrame: Baseline vs. 12 months
measure: Patient Perceived Overall Satisfaction With Support Person Support for Diabetes
timeFrame: Baseline vs. 12 months
measure: Patient Perception of Support Person Support: Supportive and Non-supportive Behaviors
timeFrame: Baseline vs. 12 months
measure: Change in Diabetes Distress in Support Person
timeFrame: Baseline vs. 12 months
measure: Change in Self-efficacy of Support Person
timeFrame: Baseline vs. 12 months
Locations:
city: Detroit
country: United States
facility: Community Health and Social Services Center (CHASS)
state: Michigan
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ann-Marie Rosland, MD,MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.