Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support
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|ClinicalTrials.gov Identifier: NCT03812614|
Recruitment Status : Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus High Blood Pressure High Blood Sugar Hypertension||Behavioral: FAM ACT Behavioral: I-DSME+CM||Not Applicable|
FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes management:
- provide family members core behavioral strategies, hands-on training, and tools directed at specific roles in supporting diabetes management (e.g. how to support action planning and medication adherence)
- teach family members how to deliver support in ways that will empower patients and not sabotage support efforts (e.g. empathetic and autonomy supportive communication)
- teach family supporters ways to boost patient engagement in healthcare (e.g. how to support healthcare visit preparation and participatory communication with providers)
CHWs will deliver FAM-ACT through family-focused group DSME sessions plus family-focused care management sessions to patient-family supporter dyads at an urban federally qualified health center. 244 patients with type 2 diabetes, and either poor glycemic or blood pressure control, will be randomized together with a family supporter, to receive either FAM-ACT or more traditional CHW-led individually-focused DSME/CM over 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||488 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
This is a randomized comparative effectiveness trial comparing two interventions.
The participants and staff delivering the interventions will not be blinded, but the data analyst will be.
This trial aims to compare the effect of the FAM-ACT intervention on patients' diabetes-related health behaviors and outcomes compared to individually-focused DSME and care management.
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Outcomes Assessor will be unaware of the arm assignment of the participant when assessing main outcomes.|
|Primary Purpose:||Health Services Research|
|Official Title:||Comparative Effectiveness of Adding Family Supporter Training to a CHW-Led Intervention to Improve Behavioral Management of Multiple Risk Factors for Diabetes Complications|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2024|
Experimental: FAM ACT
Patient-family supporter dyads assigned to the FAM-ACT arm will receive: 1) an initial patient and family supporter assessment and orientation to providing productive support for self-management, 2) family-focused information and skills training in six group DSME sessions, 3) bi-weekly care management contacts with patients and family supporters for the remainder of a 12-month period, and 4) guidance on how dyads can best prepare for and participate in primary care appointments.
Behavioral: FAM ACT
Patient and family supporter will receive an initial assessment and orientation; family-focused information/skills training through six extended DSME sessions; care management contacts with CHW for remainder of a 12-month period; and guidance on how to prepare for/participate in care appointments.
Other Name: Families Taking Action for Health
Active Comparator: I-DSME+CM
Patient-family supporter dyads assigned to the I-DSME + CM arm will receive: 1) an initial patient needs assessment and orientation, 2) six group DSME sessions, 3) bi-weekly care management contacts for the remainder of a 12-month period, and 4) guidance on how patients can prepare for and participate in primary care appointments. Family supporters will be allowed to attend the sessions if they choose, but these sessions and care management contacts will lack special emphasis on the family supporter role.
Participants will receive an initial patient needs assessment, six group DSME sessions, care management contacts for the remainder of a 12-month period, and guidance on how patients can prepare for and participate in primary care appointments.
Other Name: Indiv-Focused DM Self-Management Education & Care Management
- Change from baseline in hemoglobin A1C at 12 months [ Time Frame: Baseline vs. 12 months ]Change from baseline in hemoglobin A1C at 12 months
- Change in patient diabetes self-management behavior adherence at 12 months [ Time Frame: Baseline vs. 12 months ]The summary of diabetes self-care activities validated survey measure (SDSCA) measured via patient survey assessment at baseline and 12 month time points. The SDSCA score will be calculated from 6 items each assessing one aspect of the diabetes regimen: general diet, specific diet, exercise, medication taking, blood glucose testing, and foot care. Item answers range from 0-7 days in the last week that the behavior was adhered to. The mean of item scores will be taken so the overall score will range from 0 to 7. Missing item will be allowed for blood-glucose testing if it is not recommended by the participant's health care provider
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812614
|Contact: Ann-Marie R Rosland, MD, MSfirstname.lastname@example.org|
|Contact: Howard R Stein, MSemail@example.com|
|United States, Michigan|
|Community Health and Social Services Center (CHASS)||Not yet recruiting|
|Detroit, Michigan, United States, 48209|
|Contact: Gloria H Palmisano, MA 313-849-3920 GPalmisano@chasscenter.org|
|Contact: Deliana Ilarraza 313-849-3920 ext 5026 DIlarraza@chasscenter.org|
|Principal Investigator: Michelle Heisler, MD MPH|
|United States, Pennsylvania|
|University of Pittsburgh||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Howard R Stein, MS 412-586-9782 firstname.lastname@example.org|
|Principal Investigator:||Ann-Marie Rosland, MD,MS||University of Pittsburgh|