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

University of Pittsburgh

Status: Completed

Conditions: Hypertension; High Blood Pressure; Diabetes Mellitus; High Blood Sugar

Treatments: Behavioral: FAM ACT; Behavioral: I-DSMES

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03812614

STUDY20110344

R01DK116733 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 444 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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444 participants in 2 patient groups

FAM-ACT

Experimental group

Description:

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.

Treatment:

Behavioral: FAM ACT

I-DSMES

Active Comparator group

Description:

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.

Treatment:

Behavioral: I-DSMES