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

NCT03812614 | Completed Results DMC

• 2 other identifiers: STUDY20110344R01DK116733
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 2

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Change From Baseline in Patient Glycemic Control at 12 Months

  Baseline vs. 12 months

• Change From Baseline in Patient Systolic Blood Pressure at 6 Months

  Baseline vs. 6 months

• Change From Baseline in Patient Systolic Blood Pressure at 12 Months

  Baseline vs. 12 months

• Change From Baseline in Patient Diabetes Distress at 6 Months

  Baseline vs. 6 months

• Change From Baseline in Patient Diabetes Distress at 12 Months

  Baseline vs. 12 months

Other Outcomes (9)

• Change in Diabetes Self-care Behaviors in Patient: Healthy Eating

  Baseline vs. 12 months

• Change in Diabetes Self-care Behaviors in Patient: Physical Activity

  Baseline vs. 12 months

• Change in Diabetes Self-care Behaviors in Patient: Medication Adherence

  Baseline vs. 12 months

Study Arms (2)

FAM-ACT

EXPERIMENTAL

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.

Behavioral: FAM ACT

I-DSMES

ACTIVE COMPARATOR

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.

Behavioral: I-DSMES

Interventions

FAM ACT BEHAVIORAL

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.

Also known as: Family Support for Health Action

FAM-ACT

I-DSMES BEHAVIORAL

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.

Also known as: Individual-Focused DM Self-Management Education and Support

I-DSMES

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Able to attend intervention sessions in person or remotely via online video-conferencing
• At least 21 years old
• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead
• The Community Health and Social Services Center, Inc.: collaborator
• University of Michigan: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Community Health and Social Services Center (CHASS)

Detroit, Michigan, 48209, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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.

  PMID: 36192769 BACKGROUND

• 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.

  PMID: 35301642 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Hyperglycemia; Patient Participation

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

Many patients were due for the 6-month A1c measure (main outcome) during the height of the COVID-19 pandemic when restrictions on face-to-face research activities prevented us from collecting the data and they missed this outcome window. Two compensatory strategies were enacted: (a) review patients' EHR to identify additional A1c data during the collection window and (b) send patients home A1c test kits. This did yield some additional data, but we still missed 6-month A1c data for many patients.

Results Point of Contact

• Title: Ann-Marie Rosland, MD, MS
• Organization: University of Pittsburgh School of Medicine

roslandam@pitt.edu

412-648-5660

Study Officials

• Ann-Marie Rosland, MD,MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor will be unaware of the arm assignment of the participant when assessing main outcomes.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: September 23, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 13, 2025
• Results First Posted: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become available beginning 6 months and ending 36 months after the primary trial results are published.
• 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.

Locations

US (2)