Back to resultsComparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support
Primary Purpose
Diabetes Mellitus, High Blood Pressure, High Blood Sugar
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FAM ACT
I-DSMES
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes Mellitus focused on measuring Diabetes, Patient Activation, Self Management Education, Self Management Behavior, Autonomy Support, Social Support, Caregiver, Family Support, Glycemic Control
Eligibility Criteria
Patient Inclusion Criteria:
- 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
Patient Exclusion Criteria:
- 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)
Support Person Inclusion Criteria:
- Able to attend intervention sessions in person or remotely via online video-conferencing
- At least 21 years old
Support Person Exclusion Criteria:
- 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)
- Lives in a nursing home or long-term care facility
- Concerns that may make it difficult to participate (ongoing health issues, personal events, etc.)
Sites / Locations
- Community Health and Social Services Center (CHASS)
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FAM-ACT
I-DSMES
Arm Description
Patient and Support Person (dyad) will be included together as much as possible. The dyad will: Take part in a one-hour introductory session and review of the patient's Diabetes Complications Risk Assessment profile. Be invited to 4-6 Support Person-focused, group diabetes self-management education (DSME) sessions lasting 1-2 ½ hours each. 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.
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: Take part in a one-hour introductory session and review of patient's diabetes management risk assessment. Be invited to 4-6 group diabetes self-management education (DSME) sessions lasting 45 min to 2 hours each. 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.
Outcomes
Primary Outcome Measures
Change from baseline in patient glycemic control at 6 months
Hemoglobin A1c (HbA1c) in % will be measured through finger stick performed by a study RA, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit.
Secondary Outcome Measures
Change from baseline in patient glycemic control at 12 months
Hemoglobin A1c (HbA1c) in % will be measured through finger stick performed by a study RA, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit.
Change in systolic blood pressure
SBP will be measured using an electronic, upper arm blood pressure monitor.
Change in systolic blood pressure
SBP will be measured using an electronic, upper arm blood pressure monitor.
Change in diabetes distress in patient
Patient diabetes distress will be assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items will be summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.
Change in diabetes distress in patient
Patient diabetes distress will be assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items will be summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.
Change in diabetes self-care behaviors in patient: Healthy Eating
The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.
Change in diabetes self-care behaviors in patient: Physical Activity
The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.
Change in diabetes self-care behaviors in patient: Medication Adherence
The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.
Change in self-efficacy of patient
Patient self-efficacy for managing diabetes will be assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy.
Change in patient activation in patient
Patient activation will be assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation.
Patient perceived overall satisfaction with SP support for diabetes
Patient satisfaction with SP support for diabetes will be assessed with o items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses will be rated on a 7-point scale ranging from "strongly disagree" to "strongly agree". Responses are summed to create a total score with higher numbers indicating greater satisfaction.
Patient perception of SP support: Supportive and non-supportive behaviors
Patient perception of SP's supportive behaviors will be assessed using the 8-item Important Other Climate Questionnaire (IOCQ) and non-supportive behaviors using 3 similarly-structured items addressing SP irritation, criticism and argumentativeness. All items are rated on a 7-point scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"), with non-supportive behavior items being reversed scored.
Impact of COVID on ability to manage diabetes
Impact of COVID on Ability to Manage Diabetes will be assessed with a single closed-ended item: "In the last six months, how have the COVID pandemic or social distancing rules affected your ability to manage your diabetes?" The item is rated on a 5-point scale ranging from "much harder" to "much easier".
Change in diabetes distress in support person
Support person distress about the patient's diabetes will be assessed using the Problem Areas in Diabetes (PAID-5) Scale (for family members). The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items will be summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.
Change in self-efficacy of support person
Support person self-efficacy for helping the patient with managing diabetes will be assessed with the Self-Efficacy for Managing Chronic Diseases Scale (adapted for support persons). The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can help patients perform tasks related to their diabetes management. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy.
Full Information
NCT ID
NCT03812614
First Posted
January 18, 2019
Last Updated
August 4, 2023
Sponsor
University of Pittsburgh
Collaborators
The Community Health and Social Services Center, Inc., University of Michigan, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT03812614
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 23, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
The Community Health and Social Services Center, Inc., University of Michigan, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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):
coach family supporters in regular discussions about AWDs' diabetes progress and goals that uses empathetic and autonomy-supportive communication,
coach family supporters in practical roles that support diabetes-specific tasks tailored to AWDs' personal goals,
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
InvestigatorOutcomes Assessor
Masking Description
Outcomes Assessor will be unaware of the arm assignment of the participant when assessing main outcomes.
Allocation
Randomized
Enrollment
444 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FAM-ACT
Arm Type
Experimental
Arm Description
Patient and Support Person (dyad) will be included together as much as possible. The dyad will:
Take part in a one-hour introductory session and review of the patient's Diabetes Complications Risk Assessment profile.
Be invited to 4-6 Support Person-focused, group diabetes self-management education (DSME) sessions lasting 1-2 ½ hours each.
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.
Arm Title
I-DSMES
Arm Type
Active Comparator
Arm 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:
Take part in a one-hour introductory session and review of patient's diabetes management risk assessment.
Be invited to 4-6 group diabetes self-management education (DSME) sessions lasting 45 min to 2 hours each.
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.
Intervention Type
Behavioral
Intervention Name(s)
FAM ACT
Other Intervention Name(s)
Family Support for Health Action
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
I-DSMES
Other Intervention Name(s)
Individual-Focused DM Self-Management Education and Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in patient glycemic control at 6 months
Description
Hemoglobin A1c (HbA1c) in % will be measured through finger stick performed by a study RA, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit.
Time Frame
Baseline vs. 6 months
Secondary Outcome Measure Information:
Title
Change from baseline in patient glycemic control at 12 months
Description
Hemoglobin A1c (HbA1c) in % will be measured through finger stick performed by a study RA, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit.
Time Frame
Baseline vs. 12 months
Title
Change in systolic blood pressure
Description
SBP will be measured using an electronic, upper arm blood pressure monitor.
Time Frame
Baseline vs. 6 months
Title
Change in systolic blood pressure
Description
SBP will be measured using an electronic, upper arm blood pressure monitor.
Time Frame
Baseline vs. 12 months
Title
Change in diabetes distress in patient
Description
Patient diabetes distress will be assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items will be summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.
Time Frame
Baseline vs. 6 months
Title
Change in diabetes distress in patient
Description
Patient diabetes distress will be assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items will be summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.
Time Frame
Baseline vs. 12 months
Title
Change in diabetes self-care behaviors in patient: Healthy Eating
Description
The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.
Time Frame
Baseline vs. 6 months
Title
Change in diabetes self-care behaviors in patient: Physical Activity
Description
The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.
Time Frame
Baseline vs. 6 months
Title
Change in diabetes self-care behaviors in patient: Medication Adherence
Description
The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.
Time Frame
Baseline vs. 6 months
Title
Change in self-efficacy of patient
Description
Patient self-efficacy for managing diabetes will be assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy.
Time Frame
Baseline vs. 6 months
Title
Change in patient activation in patient
Description
Patient activation will be assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation.
Time Frame
Baseline vs. 6 months
Title
Patient perceived overall satisfaction with SP support for diabetes
Description
Patient satisfaction with SP support for diabetes will be assessed with o items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses will be rated on a 7-point scale ranging from "strongly disagree" to "strongly agree". Responses are summed to create a total score with higher numbers indicating greater satisfaction.
Time Frame
Baseline vs. 6 months
Title
Patient perception of SP support: Supportive and non-supportive behaviors
Description
Patient perception of SP's supportive behaviors will be assessed using the 8-item Important Other Climate Questionnaire (IOCQ) and non-supportive behaviors using 3 similarly-structured items addressing SP irritation, criticism and argumentativeness. All items are rated on a 7-point scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"), with non-supportive behavior items being reversed scored.
Time Frame
Baseline vs. 6 months
Title
Impact of COVID on ability to manage diabetes
Description
Impact of COVID on Ability to Manage Diabetes will be assessed with a single closed-ended item: "In the last six months, how have the COVID pandemic or social distancing rules affected your ability to manage your diabetes?" The item is rated on a 5-point scale ranging from "much harder" to "much easier".
Time Frame
Cross-sectional at 6 months
Title
Change in diabetes distress in support person
Description
Support person distress about the patient's diabetes will be assessed using the Problem Areas in Diabetes (PAID-5) Scale (for family members). The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items will be summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.
Time Frame
Baseline vs. 6 months
Title
Change in self-efficacy of support person
Description
Support person self-efficacy for helping the patient with managing diabetes will be assessed with the Self-Efficacy for Managing Chronic Diseases Scale (adapted for support persons). The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can help patients perform tasks related to their diabetes management. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy.
Time Frame
Baseline vs. 6 months
Other Pre-specified Outcome Measures:
Title
Change in diabetes self-care behaviors in patient: Healthy Eating
Description
The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.
Time Frame
Baseline vs. 12 months
Title
Change in diabetes self-care behaviors in patient: Physical Activity
Description
The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.
Time Frame
Baseline vs. 12 months
Title
Change in diabetes self-care behaviors in patient: Medication Adherence
Description
The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.
Time Frame
Baseline vs. 12 months
Title
Change in self-efficacy of patient
Description
Patient self-efficacy for managing diabetes will be assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy.
Time Frame
Baseline vs. 12 months
Title
Change in patient activation in patient
Description
Patient activation will be assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation.
Time Frame
Baseline vs. 12 months
Title
Patient perceived overall satisfaction with SP support for diabetes
Description
Patient satisfaction with SP support for diabetes will be assessed with o items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses will be rated on a 7-point scale ranging from "strongly disagree" to "strongly agree". Responses are summed to create a total score with higher numbers indicating greater satisfaction.
Time Frame
Baseline vs. 12 months
Title
Patient perception of SP support: Supportive and non-supportive behaviors
Description
Patient perception of SP's supportive behaviors will be assessed using the 8-item Important Other Climate Questionnaire (IOCQ) and non-supportive behaviors using 3 similarly-structured items addressing SP irritation, criticism and argumentativeness. All items are rated on a 7-point scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"), with non-supportive behavior items being reversed scored.
Time Frame
Baseline vs. 12 months
Title
Impact of COVID on ability to manage diabetes
Description
Impact of COVID on Ability to Manage Diabetes will be assessed with a single closed-ended item: "In the last six months, how have the COVID pandemic or social distancing rules affected your ability to manage your diabetes?" The item is rated on a 5-point scale ranging from "much harder" to "much easier".
Time Frame
Cross-sectional at 12 months
Title
Change in diabetes distress in support person
Description
Support person distress about the patient's diabetes will be assessed using the Problem Areas in Diabetes (PAID-5) Scale (for family members). The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items will be summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.
Time Frame
Baseline vs. 12 months
Title
Change in self-efficacy of support person
Description
Support person self-efficacy for helping the patient with managing diabetes will be assessed with the Self-Efficacy for Managing Chronic Diseases Scale (adapted for support persons). The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can help patients perform tasks related to their diabetes management. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy.
Time Frame
Baseline vs. 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient Inclusion Criteria:
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
Patient Exclusion Criteria:
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)
Support Person Inclusion Criteria:
Able to attend intervention sessions in person or remotely via online video-conferencing
At least 21 years old
Support Person Exclusion Criteria:
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)
Lives in a nursing home or long-term care facility
Concerns that may make it difficult to participate (ongoing health issues, personal events, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann-Marie Rosland, MD,MS
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Health and Social Services Center (CHASS)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48209
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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. Researchers 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 shared study 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. 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.
IPD Sharing Time Frame
The data will become available beginning 6 months and ending 36 months after the primary trial results are published.
IPD Sharing 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.
Citations:
PubMed Identifier
36192769
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.
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Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support
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