Diabetes MellitusNCT03812614
Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support
A study testing FAM ACT and I-DSMES in people with Diabetes Mellitus and High Blood Pressure, run by University of Pittsburgh at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Diabetes Mellitus, High Blood Pressure, High Blood Sugar
- What is being tested?
- FAM ACT and I-DSMES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Sep 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Community Health and Social Services Center (CHASS)
Detroit, Michigan, 48209
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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
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).
Read the 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.
- Conditions
- Diabetes Mellitus, High Blood Pressure, High Blood Sugar, Hypertension
- Being tested
- FAM ACT, I-DSMES
- Keywords
- Diabetes, Patient Activation, Self Management Education, Self Management Behavior, Autonomy Support, Social Support, Caregiver, Family Support, Glycemic Control
- Medical subject headings
- Diabetes Mellitus, Hypertension, Hyperglycemia, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAM ACTBehavioural
Also called Family Support for Health Action
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.
I-DSMESBehavioural
Also called Individual-Focused DM Self-Management Education and Support
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: I-DSMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline vs. 6 months
Secondary outcomes (15)
Change From Baseline in Patient Glycemic Control at 12 Months
Hemoglobin A1c (HbA1c, percent) was measured through finger stick performed by a study research assistant, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit.
Measured: Baseline vs. 12 months
Change From Baseline in Patient Systolic Blood Pressure at 6 Months
SBP was measured using an electronic, upper arm blood pressure monitor.
Measured: Baseline vs. 6 months
Change From Baseline in Patient Systolic Blood Pressure at 12 Months
SBP was measured using an electronic, upper arm blood pressure monitor.
Measured: Baseline vs. 12 months
Change From Baseline in Patient Diabetes Distress at 6 Months
Patient diabetes distress was 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 were 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.
Measured: Baseline vs. 6 months
Change From Baseline in Patient Diabetes Distress at 12 Months
Patient diabetes distress was 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 were 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.
Measured: Baseline vs. 12 months
Change From Baseline Patient Diabetes Self-care Behaviors at 6 Months: 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. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence.
Measured: Baseline vs. 6 months
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. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence.
Measured: Baseline vs. 6 months
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. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. Three types of medication adherence were assessed: number of days diabetes medications (non-insulin) were taken; number of days blood pressure medications were taken; number of days cholesterol medications were taken. Note that the Ns with data for these three measures are smaller than the Ns for diet and physical activity data. Differences are due to some patients not having been prescribed non-insulin diabetes, blood pressure and/or cholesterol medications.
Measured: Baseline vs. 6 months
Change in Self-efficacy of Patient
Patient self-efficacy for managing diabetes was 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 (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy.
Measured: Baseline vs. 6 months
Change in Patient Activation in Patient
Patient activation was 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. Item scale locations were transformed from the original logit metric to a user-friendly 0-100 metric where 0=the lowest possible activation and 100=the highest possible activation as measured by this set of items. While the metric allows for a potential range of 0-100, the items included in the measure only covered the range from 40 (minimum) to 60 (maximum), not tapping what would be theoretically the lowest or highest ranges of the construct.
Measured: Baseline vs. 6 months
Patient Perceived Overall Satisfaction With SP Support for Diabetes
Patient satisfaction with support person (SP) support for diabetes was assessed with 2* 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 were rated on a 7-point scale ranging from 1, "strongly disagree" to 7 "strongly agree". Responses are summed to create a total score with a range of 2 to 14. Higher numbers indicate greater satisfaction.
Measured: Baseline vs. 6 months
Patient Perception of SP Support: Supportive and Non-supportive Behaviors
Patient perception of support persons' (SP) supportive behaviors was 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 0 ("strongly disagree") to 6 ("strongly agree"), with non-supportive behavior items being reversed scored. Item responses were averaged to create a mean score with a possible range of 0 (low support) to 6 (high support).
Measured: Baseline vs. 6 months
Impact of COVID on Ability to Manage Diabetes
Impact of COVID on ability to manage Diabetes was 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". Due to small numbers, the variable was collapsed to 3 categories for analysis: harder/much harder, no change, easier/much easier.
Measured: Cross-sectional at 6 months
Change in Diabetes Distress in Support Person
Support person distress about the patient's diabetes was 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 were 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.
Measured: Baseline vs. 6 months
Change in Self-efficacy of Support Person
Support person self-efficacy for helping the patient with managing diabetes was 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 (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy.
Measured: Baseline vs. 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start23 Sep 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- The Community Health and Social Services Center, Inc., University of Michigan, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Ann-Marie Rosland, University of Pittsburgh
- Investigators
- Ann-Marie Rosland, MD,MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812614
- Sponsor's protocol ID
- STUDY20110344
- Other IDs
- R01DK116733
- Status last verified
- Feb 2025
- First submitted
- 18 Jan 2019
- Last updated
- 13 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36192769Zupa 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.
PubMed 35301642Deverts DJ, F Zupa M, Kieffer EC, Piatt GA, Heisler M, Valbuena F, Gonzalez S, Guajardo C, Yabes JG, Lalama C, Rosland AM. Transition to Virtual Diabetes Self-Management Education Delivery in the Setting of Health Care Disruption for Adults With Diabetes and Their Support Persons. Sci Diabetes Self Manag Care. 2026 Jun;52(3):229-242. doi: 10.1177/26350106261432172. Epub 2026 Apr 9.
PubMed 41958056
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03812614
- Acronym / sponsor ID
- STUDY20110344
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- The Community Health and Social Services Center, Inc., University of Michigan, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Posted 13 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| FAM-ACT | Experimental | Behavioral: FAM ACTPatient 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. |
| I-DSMES | Active comparator | Behavioral: I-DSMESThis 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAM ACTAlso: Family Support for Health ActionPatient 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. | Behavioural | FAM-ACT |
| I-DSMESAlso: Individual-Focused DM Self-Management Education and SupportPatient 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. | Behavioural | I-DSMES |
Primary outcome
Change From Baseline in Patient Glycemic Control at 6 Months
Time frame: Baseline vs. 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.
15 secondary outcomes
Change From Baseline in Patient Glycemic Control at 12 Months
Time frame: Baseline vs. 12 months
Change From Baseline in Patient Systolic Blood Pressure at 6 Months
Time frame: Baseline vs. 6 months
Change From Baseline in Patient Systolic Blood Pressure at 12 Months
Time frame: Baseline vs. 12 months
Change From Baseline in Patient Diabetes Distress at 6 Months
Time frame: Baseline vs. 6 months
Change From Baseline in Patient Diabetes Distress at 12 Months
Time frame: Baseline vs. 12 months
Change From Baseline Patient Diabetes Self-care Behaviors at 6 Months: Healthy Eating
Time frame: Baseline vs. 6 months
Change in Diabetes Self-care Behaviors in Patient: Physical Activity
Time frame: Baseline vs. 6 months
Change in Diabetes Self-care Behaviors in Patient: Medication Adherence
Time frame: Baseline vs. 6 months
Change in Self-efficacy of Patient
Time frame: Baseline vs. 6 months
Change in Patient Activation in Patient
Time frame: Baseline vs. 6 months
Patient Perceived Overall Satisfaction With SP Support for Diabetes
Time frame: Baseline vs. 6 months
Patient Perception of SP Support: Supportive and Non-supportive Behaviors
Time frame: Baseline vs. 6 months
Impact of COVID on Ability to Manage Diabetes
Time frame: Cross-sectional at 6 months
Change in Diabetes Distress in Support Person
Time frame: Baseline vs. 6 months
Change in Self-efficacy of Support Person
Time frame: Baseline vs. 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36192769Deverts 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.
- Background: PubMed 35301642Zupa 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.
- Derived from this study: PubMed 41958056Deverts DJ, F Zupa M, Kieffer EC, Piatt GA, Heisler M, Valbuena F, Gonzalez S, Guajardo C, Yabes JG, Lalama C, Rosland AM. Transition to Virtual Diabetes Self-Management Education Delivery in the Setting of Health Care Disruption for Adults With Diabetes and Their Support Persons. Sci Diabetes Self Manag Care. 2026 Jun;52(3):229-242. doi: 10.1177/26350106261432172. Epub 2026 Apr 9.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann-Marie Rosland, MD,MS principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAM ACT and I-DSMES in people with Diabetes Mellitus and High Blood Pressure, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Patient Glycemic Control at 6 Months (time frame: Baseline vs. 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03812614, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.