Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support
Study Details
Study Description
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 |
|---|---|---|
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N/A |
Detailed Description
FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes management:
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Provide Support Person with core behavioral strategies, hands-on training, and tools directed at specific roles in supporting diabetes management (e.g. how to support action planning and medication adherence).
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Teach Support Person how to deliver support in ways that will empower patients and not sabotage support efforts (e.g. empathetic and autonomy-supportive communication).
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Teach Support Person ways to boost patient engagement in healthcare (e.g. how to support healthcare visit preparation and participatory communication with providers).
CHWs will deliver FAM-ACT through Support Person-focused group DSME sessions plus Support Person-focused care management sessions to Patient-Support Person dyads at an urban federally qualified health center. When situationally appropriate, the care management sessions will be conducted by phone/video call or using a HIPAA-compliant online video-conferencing platform. 268 patients with type 2 diabetes and either poor glycemic or blood pressure control will be randomized together with a member or friend (known as a Support Person) to receive either FAM-ACT or more traditional CHW-led patient-focused DSME/CM over 6 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FAM ACT 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. |
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.
Other Names:
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| Active Comparator: I-DSME + CM This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. Patients assigned to this arm will: 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. |
Behavioral: I-DSME+CM
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change from baseline in patient glycemic control at 6 months [Baseline vs. 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
- 12-month change in patient glycemic control [Baseline vs. 12 months]
Hemoglobin A1c (HbA1c) in% will be measured through finger stick.
- Change in diabetes distress in patient [Baseline vs. 6 months, Baseline vs. 12 months (extended outcome)]
Problem Areas in Diabetes (PAID-5) is a validated short version which measures diabetes-related emotional distress. This 5-item scale which has a five-point response option (0-4 representing 'Not a problem' through to 'serious problem'). The scale's 5 items will be added to create a range from 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 support person [Baseline vs. 6 months, Baseline vs. 12 months (extended outcome)]
Problem Areas in Diabetes (PAID-5) is a validated short version which measures diabetes-related emotional distress. This 5-item scale which has a five-point response option (0-4 representing 'Not a problem' through to 'serious problem'). The scale's 5 items will be added to create a range from 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 patient activation in patient [Baseline vs. 6 months, Baseline vs. 12 months (extended outcome)]
The Patient Activation Measure (PAM) scale measures an individual's self-management ability. It shows how ready, willing and able an individual is to manage his or her health and healthcare. After the PAM is completed, an individual will fall into 1 of 4 levels of activation along a 100- point, empirically-derived scale: 'Low' (Levels 1 & 2), 'Moderate' (Level 3), and 'High' (Level 4). Typically, levels 1 and 2 are more similar, with Level 3 being a clear bridge to the highest activation, Level 4.
- Change in self-efficacy of patient [Baseline vs. 6 months, Baseline vs. 12 months (extended outcome)]
The score for each item is the number circled. If two consecutive numbers are circled, code the lower number (less self-efficacy). If the numbers are not consecutive, do not score the item. The score for the scale is the mean of the six items. If more than two items are missing, do not score the scale. Higher number indicates higher self- efficacy.
- Change in self-efficacy of support person [Baseline vs. 6 months, Baseline vs. 12 months (extended outcome)]
The score for each item is the number circled. If two consecutive numbers are circled, code the lower number (less self-efficacy). If the numbers are not consecutive, do not score the item. The score for the scale is the mean of the six items. If more than two items are missing, do not score the scale. Higher number indicates higher self- efficacy.
- Change in autonomy support - perceived autonomy by patient for diabetes self-management from support person [Baseline vs. 6 months, Baseline vs. 12 months (extended outcome)]
Important Others Climate Questionnaire (IOCQ) measures the degree of autonomy support patients experience from important others (non- health care professionals). Each item is rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Scores are computed by averaging responses to the (6) items
- Change in diabetes self-care behaviors in patient: Healthy Eating [Baseline vs. 6 months, Baseline vs. 12 months (extended outcome)]
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 [Baseline vs. 6 months, Baseline vs. 12 months (extended outcome)]
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 [Baseline vs. 6 months, Baseline vs. 12 months (extended outcome)]
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 systolic blood pressure [Baseline vs. 6 months, Baseline vs. 12 months (extended outcome)]
SBP will be measured using an electronic, upper arm blood pressure monitor.
- Patient perceived overall satisfaction with SP support for diabetes [Baseline vs. 6 months, Baseline vs. 12 months (extended outcome)]
Patient satisfaction with SP support for diabetes will be assessed with a single closed-ended item: "I am very satisfied with the help and support I receive from [SP name] in caring for my diabetes". Responses will be rated on a 7-point scale ranging from "strongly disagree" to "strongly agree".
- Patient perception of SP support: Supportive and non-supportive behaviors [Baseline vs. 6 months, Baseline vs. 12 months (extended outcome)]
Patient perception of SP support will be assessed using 2 open-ended items: "Over the last 6 months, did your Support Person do anything that helped you manage your diabetes? Tell me about what they did." and "Over the last 6 months, did your Support Person do anything that made it more difficult to manage your diabetes? Tell me about what they did."
- Impact of COVID on ability to manage diabetes [Cross-sectional at 6 months, Cross-sectional at 12 months (extended outcome)]
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"
Eligibility Criteria
Criteria
Patient Inclusion Criteria:
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Have a diagnosis of Type 2 diabetes
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Most recent HbA1c done in the 3 months prior to screening phone call > 8.0%
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Plan to use recruiting site for health care over the next 12 months after enrollment
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Must be able to identify a family member or friend who is willing to be involved in their health care
Patient Exclusion Criteria:
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Diagnosis (active or prior) of Alzheimer's disease or dementia
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Preferred language is not English or Spanish
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Diagnosis (active or prior) of schizophrenia or other psychotic/delusional disorder in CHASS EMR Problem list as of screening call date
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Diagnosis of gestational diabetes without any other diabetes diagnoses
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Diagnosed with diabetes at age < 21 years
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Pregnant or planning to become pregnant in the next 12 months
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Concerns that may make it difficult to participate (ongoing health issues, personal events, etc.)
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Have a life-limiting severe illness (e.g. chronic obstructive pulmonary disease requiring oxygen)
Support Person Inclusion Criteria:
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Able to attend intervention sessions in person or remotely via online video-conferencing
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At least 21 years old
Support Person Exclusion Criteria:
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Does not speak English or Spanish
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Receives pay for caring for the patient
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Has self-reported serious mental illness (schizophrenia)
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Has a life-limiting severe illness (e.g. chronic obstructive pulmonary disease requiring oxygen)
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Has significant cognitive impairment (Alzheimer's disease or dementia)
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Lives in a nursing home or long-term care facility
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Concerns that may make it difficult to participate (ongoing health issues, personal events, etc.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Community Health and Social Services Center (CHASS) | Detroit | Michigan | United States | 48209 |
| 2 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- University of Pittsburgh
- The Community Health and Social Services Center, Inc.
- University of Michigan
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Ann-Marie Rosland, MD,MS, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO17110403
- R01DK116733