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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03812614
Recruitment Status : Suspended (Study recruitment is temporarily suspended to maximize the safety of participants and staff due to current concerns about transmission of COVID-19.)
First Posted : January 23, 2019
Last Update Posted : April 20, 2020
Sponsor:
Collaborators:
The Community Health and Social Services Center, Inc.
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ann-Marie Rosland, University of Pittsburgh

Brief Summary:
The objective of this study is to compare the effectiveness of a novel program—Family Partners for Health Action (FAM-ACT) - to individual patient-focused diabetes self-management education and care management(I-DSMES/CM).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus High Blood Pressure High Blood Sugar Hypertension Behavioral: FAM ACT Behavioral: I-DSMES+CM Not Applicable

Detailed Description:

FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes management:

  1. Provide Support Person with core behavioral strategies, hands-on training, and tools directed at specific roles in supporting diabetes management (e.g. how to support action planning and medication adherence).
  2. Teach Support Person how to deliver support in ways that will empower patients and not sabotage support efforts (e.g. empathetic and autonomy-supportive communication).
  3. Teach Support Person ways to boost patient engagement in healthcare (e.g. how to support healthcare visit preparation and participatory communication with providers).

CHWs will deliver FAM-ACT through Support Person-focused group DSMES sessions plus Support Person-focused care management sessions to Patient-Support Person dyads at an urban federally qualified health center. 268 patients with type 2 diabetes and either poor glycemic or blood pressure control will be randomized together with a member or friend (known as a Support Person) to receive either FAM-ACT or more traditional CHW-led patient-focused DSMES/CM over 12 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 536 participants
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 DSMES and care management.

Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Outcomes Assessor will be unaware of the arm assignment of the participant when assessing main outcomes.
Primary Purpose: Health Services Research
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
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FAM ACT

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 sessions lasting approximately 2 ½ hours each.
  3. Receive case management contacts with a Community Health Worker (CHW) every 2-4 weeks for approximately 20 minutes each time for the remainder of the 12-month enrollment period.
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 DSMES sessions, case management contacts with CHW for the remainder of a 12-month period, and guidance on how to prepare for and participate in healthcare appointments.
Other Name: Families Taking Action for Health

Active Comparator: I-DSMES + CM

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 sessions lasting approximately 2 hours each.
  3. Receive case management contacts with a Community Health Worker (CHW) every 2-4 weeks for approximately 20 minutes each time for the remainder of the 12-month enrollment period.
Behavioral: I-DSMES+CM
Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSMES sessions, case management contacts with CHW for the remainder of a 12-month period, and guidance on how to prepare for and participate in healthcare appointments.
Other Name: Indiv-Focused DM Self-Management Education and Support & Care Management




Primary Outcome Measures :
  1. Change from baseline in patient glycemic control at 12 months [ Time Frame: Baseline vs. 12 months ]
    Hemoglobin A1c (HbA1c) in % will be measured through finger stick.


Secondary Outcome Measures :
  1. Change in diabetes-specific 5-year risk of coronary heart disease in patient [ Time Frame: Baseline vs. 12 months ]
    UK Prospective Diabetes Study (UKPDS) Risk Engine derives the risk of a coronary event in the next 5 years. The engine software creates a risk percentage based on the patient's age, gender, ethnicity, smoking status, presence or absence of atrial fibrillation and levels of HbA1c, systolic blood pressure, total cholesterol, and HDL cholesterol. A higher percentage indicates a greater risk of having a CHD or fatal CHD in the next 5 years.

  2. Change from baseline in patient glycemic control at 6 months [ Time Frame: Baseline vs. 6 months ]
    Hemoglobin A1c (HbA1c) in % will be measured through finger stick.

  3. Change in diabetes self-care behaviors in patient - including domains of diet, exercise, blood sugar testing, blood pressure checking, foot care and medication taking - NEED TO FIGURE OUT WHERE BP QUESTIONS CAME FROM - NOT PART OF ORIGINAL SCALE. [ Time Frame: Baseline vs. 6 months ]
    The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different domains of the diabetes regimen. Our study will score results within each domain by averaging the item scores (each ranging from 0-7) within each domain.

  4. Change in diabetes self-care behaviors in patient - including diet, exercise, blood sugar testing, and medication taking [ Time Frame: Baseline vs. 12 months ]
    The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different domains of the diabetes regimen. Our study will score results within each domain by averaging the item scores (each ranging from 0-7) within each domain.


Other Outcome Measures:
  1. Change in blood pressure in patient [ Time Frame: Baseline vs. 6 months ]
    Blood pressure will be measured by an automatic blood pressure monitor, taking the average of two readings taken 2 minutes apart. We will average the SBP at 6 months and 12 months and compare to SBP at baseline.

  2. Change in blood pressure in patient [ Time Frame: Baseline vs. 12 months ]
    Blood pressure will be measured by an automatic blood pressure monitor, taking the average of two readings taken 2 minutes apart. We will average the SBP at 6 months and 12 months and compare to SBP at baseline.

  3. Change in cholesterol in patient [ Time Frame: Baseline vs. 6 months ]
    Lipids will be measured using an analyzer, which produces accurate results using fingerstick samples and meets guidelines set by the National Cholesterol Education Program, with coefficients of variation of <1.8%. We will compare non-HDL cholesterol readings at 6 months and 12 months and compare to non-HDL at baseline.

  4. Change in cholesterol in patient [ Time Frame: Baseline vs. 12 months ]
    Lipids will be measured using an analyzer, which produces accurate results using fingerstick samples and meets guidelines set by the National Cholesterol Education Program, with coefficients of variation of <1.8%. We will compare non-HDL cholesterol readings at 6 months and 12 months and compare to non-HDL at baseline.

  5. Change in BMI in patient [ Time Frame: Baseline vs. 6 months ]
    Patients will be weighed via scale. Height will come from electronic medical records and confirmed by patient.

  6. Change in BMI in patient [ Time Frame: Baseline vs. 12 months ]
    Patients will be weighed via scale. Height will come from electronic medical records and confirmed by patient.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 > 8.0%
  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
  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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812614


Locations
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United States, Michigan
Community Health and Social Services Center (CHASS)
Detroit, Michigan, United States, 48209
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
The Community Health and Social Services Center, Inc.
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Ann-Marie Rosland, MD,MS University of Pittsburgh
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Responsible Party: Ann-Marie Rosland, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03812614    
Other Study ID Numbers: PRO17110403
R01DK116733 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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. Secondary authors 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 study shared 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 by the CDDC website link. 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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 by study partner CHASS. No other data sharing options will be considered. The data that may be shared includes: de-identified individual participant data, tables, figures, appendices, analysis plan, and protocol.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ann-Marie Rosland, University of Pittsburgh:
Diabetes
Patient Activation
Self Management Education
Self Management Behavior
Autonomy Support
Social Support
Caregiver
Family Support
Glycemic Control
Additional relevant MeSH terms:
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Hypertension
Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases