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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03812614
• Other study ID #: STUDY20110344
• Secondary ID: R01DK116733
• Status: Completed
• Phase: N/A
• Start date: September 23, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Description:

FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes management for adults with diabetes (AWDs):

1. coach family supporters in regular discussions about AWDs' diabetes progress and goals that uses empathetic and autonomy-supportive communication,

2. coach family supporters in practical roles that support diabetes-specific tasks tailored to AWDs' personal goals,

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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 >= 7.5%

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 or remotely via online video-conferencing

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.)

Related Conditions & MeSH terms

• Diabetes Mellitus
• High Blood Pressure
• High Blood Sugar
• Hyperglycemia
• Hypertension

Intervention

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 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-DSMES
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.

Locations

Country	Name	City	State
United States	Community Health and Social Services Center (CHASS)	Detroit	Michigan
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Community Health and Social Services Center, Inc., University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Baseline vs. 12 months
Other	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.	Baseline vs. 12 months
Other	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.	Baseline vs. 12 months
Other	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.	Baseline vs. 12 months
Other	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.	Baseline vs. 12 months
Other	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.	Baseline vs. 12 months
Other	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.	Baseline vs. 12 months
Other	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".	Cross-sectional at 12 months
Other	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.	Baseline vs. 12 months
Other	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.	Baseline vs. 12 months
Primary	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. For analysis, we first will graphically examine how HbA1c changes over time. We will then conduct our main analyses using linear mixed-effects models that include repeated measures at baseline, 6 months, and 12 months.	Baseline vs. 6 months
Secondary	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.	Baseline vs. 12 months
Secondary	Change in systolic blood pressure	SBP will be measured using an electronic, upper arm blood pressure monitor.	Baseline vs. 6 months
Secondary	Change in systolic blood pressure	SBP will be measured using an electronic, upper arm blood pressure monitor.	Baseline vs. 12 months
Secondary	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.	Baseline vs. 6 months
Secondary	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.	Baseline vs. 12 months
Secondary	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.	Baseline vs. 6 months
Secondary	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.	Baseline vs. 6 months
Secondary	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.	Baseline vs. 6 months
Secondary	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.	Baseline vs. 6 months
Secondary	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.	Baseline vs. 6 months
Secondary	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.	Baseline vs. 6 months
Secondary	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.	Baseline vs. 6 months
Secondary	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".	Cross-sectional at 6 months
Secondary	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.	Baseline vs. 6 months
Secondary	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.	Baseline vs. 6 months