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

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ClinicalTrials.gov Identifier: NCT03812614
Recruitment Status : Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
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-DSME/CM).

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

Detailed Description:

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

  1. provide family members 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 family members how to deliver support in ways that will empower patients and not sabotage support efforts (e.g. empathetic and autonomy supportive communication)
  3. teach family supporters 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 family-focused group DSME sessions plus family-focused care management sessions to patient-family supporter dyads at an urban federally qualified health center. 244 patients with type 2 diabetes, and either poor glycemic or blood pressure control, will be randomized together with a family supporter, to receive either FAM-ACT or more traditional CHW-led individually-focused DSME/CM over 12 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 488 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 individually-focused DSME 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
Estimated Study Start Date : July 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-family supporter dyads assigned to the FAM-ACT arm will receive: 1) an initial patient and family supporter assessment and orientation to providing productive support for self-management, 2) family-focused information and skills training in six group DSME sessions, 3) bi-weekly care management contacts with patients and family supporters for the remainder of a 12-month period, and 4) guidance on how dyads can best prepare for and participate in primary care appointments.
Behavioral: FAM ACT
Patient and family supporter will receive an initial assessment and orientation; family-focused information/skills training through six extended DSME sessions; care management contacts with CHW for remainder of a 12-month period; and guidance on how to prepare for/participate in care appointments.
Other Name: Families Taking Action for Health

Active Comparator: I-DSME+CM
Patient-family supporter dyads assigned to the I-DSME + CM arm will receive: 1) an initial patient needs assessment and orientation, 2) six group DSME sessions, 3) bi-weekly care management contacts for the remainder of a 12-month period, and 4) guidance on how patients can prepare for and participate in primary care appointments. Family supporters will be allowed to attend the sessions if they choose, but these sessions and care management contacts will lack special emphasis on the family supporter role.
Behavioral: I-DSME+CM
Participants will receive an initial patient needs assessment, six group DSME sessions, care management contacts for the remainder of a 12-month period, and guidance on how patients can prepare for and participate in primary care appointments.
Other Name: Indiv-Focused DM Self-Management Education & Care Management




Primary Outcome Measures :
  1. Change from baseline in hemoglobin A1C at 12 months [ Time Frame: Baseline vs. 12 months ]
    Change from baseline in hemoglobin A1C at 12 months

  2. Change in patient diabetes self-management behavior adherence at 12 months [ Time Frame: Baseline vs. 12 months ]
    The summary of diabetes self-care activities validated survey measure (SDSCA) measured via patient survey assessment at baseline and 12 month time points. The SDSCA score will be calculated from 6 items each assessing one aspect of the diabetes regimen: general diet, specific diet, exercise, medication taking, blood glucose testing, and foot care. Item answers range from 0-7 days in the last week that the behavior was adhered to. The mean of item scores will be taken so the overall score will range from 0 to 7. Missing item will be allowed for blood-glucose testing if it is not recommended by the participant's health care provider



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patient Inclusion Criteria:

  1. age between 30 and 70 years old
  2. actively receiving primary care at CHASS Inc health center
  3. fluent in English or Spanish
  4. diagnosis of diabetes from two outpatient encounters at CHASS
  5. Most recent HbA1c (past 3 months) ≥8.0%

    OR poor blood pressure control [poor blood pressure control is defined as:

    (If they have >1 BP in last 6 months) Most recent SBP>=150 and mean SBP over 9 months >=150 (If only 1 BP in last 6 months) Last SBP in last 6 months >=160 and no other BP measures AND exclude from poor BP group if last BP diastolic or mean diastolic is <=65]

  6. able to identify a family member or friend who meets the family supporter inclusion/exclusion criteria below and is willing to participate in the study

Patient Exclusion Criteria:

  1. diagnosed with diabetes at age <21 years
  2. have significant cognitive impairment,
  3. need help with basic activities of daily living
  4. live in a nursing home
  5. are not able to be contacted by phone,
  6. are pregnant or planning to become pregnant during the course of the study
  7. have self-reported serious mental illness or active substance abuse, or
  8. have a life-limiting severe illness (e.g. chronic obstructive pulmonary disease requiring oxygen).

Family Supporter Inclusion Criteria:

  1. Family members or friends can live with or apart from the patient participant
  2. At least 21 years old

Family Supporter Exclusion Criteria:

  1. receive pay for caring for the patient
  2. do not speak English or Spanish
  3. are not able to be contacted by phone
  4. have self-reported serious mental illness or active substance abuse
  5. need help with basic activities of daily living, or
  6. have a life-limiting severe illness.

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


Contacts
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Contact: Ann-Marie R Rosland, MD, MS 412-692-4889 roslandam@pitt.edu
Contact: Howard R Stein, MS 412-586-9782 hos12@pitt.edu

Locations
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United States, Michigan
Community Health and Social Services Center (CHASS) Not yet recruiting
Detroit, Michigan, United States, 48209
Contact: Gloria H Palmisano, MA    313-849-3920    GPalmisano@chasscenter.org   
Contact: Deliana Ilarraza    313-849-3920 ext 5026    DIlarraza@chasscenter.org   
Principal Investigator: Michelle Heisler, MD MPH         
United States, Pennsylvania
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Howard R Stein, MS    412-586-9782    hos12@pitt.edu   
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     History of Changes
Other Study ID Numbers: PRO17110403
R01DK116733 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study investigators will make deidentified 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 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 the University of Pittsburgh 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, appendences, 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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Diabetes Mellitus
Hypertension
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases