Diabetes Self-Management Education (DSME) is recommended for patients with type 2 diabetes (T2D) by the American Diabetes Association. DSME teaches T2D patients how to engage in behaviors that are important to managing the condition. Patients in DSME classes learn how to set goals, solve problems, and overcome challenges so that they can avoid complications. However, the self-management of T2D is complex and requires changes that are often difficult for patients to adopt in their everyday life contexts of work and family. A growing body of evidence has documented the effectiveness of family-centered models of diabetes self-management education (Family-DSME) that explicitly address diabetes self-management within a family context by focusing on family motivational interviewing, family goal setting, understanding supportive and nonsupportive behaviors, and family behavioral changes. All aspects of the study are guided by a Stakeholder Advisory Board that includes patients with T2D, family members, clinicians, and other stakeholders.
The overarching research question this study addresses is: Compared to Standard-DSME, does Family-DSME yield improved outcomes among diverse patient populations with T2D and their family members? To answer this question, we will conduct a randomized controlled trial that compares the effectiveness of Standard-DSME and Family-DSME among diverse patients in University of Arkansas for Medical Sciences clinics across Arkansas. We will randomly assign 600 patients with T2D and 600 of their family members to one of the two interventions. Patients assigned to the Family-DSME intervention will invite their family members to attend the DSME classes. Patients assigned to the Standard-DSME will attend educational classes without their family members. Both interventions cover the same self-management behaviors, but Family-DSME includes topics relevant to patients and family members, such as family goal setting and information about how family members can be more supportive of the patient.
We will collect data from patients and family members assigned to both interventions at four points in time: (1) immediately before they begin attending educational sessions, (2) immediately after they complete the educational sessions, (3) six months after they complete the classes, and (4) 12 months after they complete the educational sessions. We will also pull medical records for patients with T2D 18 months after they complete the educational sessions. In addition to comparing the effectiveness of the two interventions with patients (aim 1), we will also compare the effects of the interventions on family members (aim 2) and look at how family support/involvement and improvements in family confidence to assist the patient affects patient outcomes. The outcomes we will consider include: HbA1c, blood pressure, fasting glucose, fasting lipids, waist circumference, BMI, level of family support/involvement, self-efficacy in providing support (family members), self-efficacy (patients), self-management behaviors (patients only), medication adherence (patients only), diabetes-related distress, diabetes-related quality of life, and diabetes-related complications (patients only).
Finally, to complete aim 3 of the study, the team will interview 24 participants in the study (patients with T2D and family members) to get their input on potential barriers and facilitators of dissemination and implementation, which will ensure these stakeholders’ voices are integrated into all dissemination efforts.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.