Acceptability and feasibility of FAMS-T1D mHealth intervention to optimize self- and social regulation for emerging adults with type 1 diabetes.

BACKGROUND: Among emerging adults with type 1 diabetes (T1D), self-regulation and social regulation skills can help avoid high A1c and diabetes distress. FAMS (Family/friend Activation to Motivate Self-care) is mobile phone-delivered intervention that supports development of these skills and is efficacious among adults with type 2 diabetes. However, the acceptability and feasibility of the FAMS intervention among emerging adults with T1D are unknown. METHODS: Therefore, we adapted FAMS for in a new disease context and developmental stage and then conducted a 3-month mixed-methods pre-post pilot study. Participants were emerging adults with T1D and a friend/family member enrolled as a support person (optional). Feasibility/acceptability outcomes and associated progression thresholds were recruitment (≥ 70% eligible emerging adults), retention (≥ 85%), intervention engagement (≥ 70%), and satisfaction (≥ 70%). We also collected qualitative feedback to determine if the intervention addressed relevant needs and explored changes in outcomes of interest (family/friend involvement, self-efficacy, self-management, distress, A1c). RESULTS: Recruitment rates indicate recruitment of emerging adults with T1D (n = 30) and their support persons (n = 20) is feasible - 79% of emerging adults who screened as eligible enrolled and 70% of enrolled emerging adults invited a support person. Emerging adults completed 98% of coaching sessions, and response rates to automated text messages were median 85% IQR [68%, 90%]. Changes in selected measures for outcomes of interest were in expected directions suggesting sensitivity to changes occasioned by the intervention in a future evaluative trial. Emerging adults said FAMS-T1D helped with setting realistic goals, motivated them to prioritize diabetes goals, and increased support, indicating acceptability of the intervention in this new disease and developmental context. CONCLUSIONS: Findings suggest potential for FAMS-T1D to engage emerging adults and their support persons and feasibility for an evaluative trial examining effects on self-regulation (self-efficacy, self-management), social regulation (family/friend involvement), and outcomes (diabetes distress, A1c). TRIAL REGISTRATION: We did not register this study on ClinicalTrials.gov because the purpose of the study was to assess the feasibility and acceptability of the intervention and study procedures and measures in preparation for a future trial. The purpose of that future trial will be to evaluate the effect of the intervention on health-related biomedical and behavioral outcomes, and that trial will be registered accordingly.

Acceptability and Feasibility of FAMS-T1D mHealth intervention to optimize self- & social regulation for emerging adults with type 1 diabetes.

Background: Among emerging adults with type 1 diabetes (T1D), self-regulation and social regulation skills can help avoid high A1c and diabetes distress. FAMS (Family/friend Activation to Motivate Self-care) is mobile phone-delivered intervention that supports development of these skills and is efficacious among adults with type 2 diabetes. However, the acceptability and feasibility of the FAMS intervention among emerging adults with T1D is unknown. Methods: Therefore, we adapted FAMS for in a new disease context and developmental stage then conducted a 3-month mixed-methods pre-post pilot study. Participants were emerging adults with T1D and a friend/family member enrolled as a support person (optional). Feasibility/acceptability outcomes and associated progression thresholds were recruitment (≥ 70% eligible emerging adults), retention (≥ 85%), intervention engagement (≥ 70%) and satisfaction (≥ 70%). We also collected qualitative feedback to determine if the intervention addressed relevant needs and explored changes in outcomes of interest (family/friend involvement, self-efficacy, self-management, distress, A1c). Results: Recruitment rates indicate recruitment of emerging adults with T1D and their support persons is feasible - 79% of emerging adults who screened as eligible enrolled and 70% of enrolled emerging adults invited a support person. Emerging adults completed 98% of coaching sessions, and response rates to automated text messages were median 85% IQR [68%, 90%]. Changes in selected measures for outcomes of interest were in expected directions suggesting sensitivity to changes occasioned by the intervention in a future evaluative trial. Emerging adults said FAMS-T1D helped with setting realistic goals, motivated them to prioritize diabetes goals, and increased support, indicating acceptability of the intervention in this new disease and developmental context. Conclusions: Findings suggest potential for FAMS-T1D to engage emerging adults and their support persons and feasibility for evaluation of effects on hypothesized intervention targets and outcomes in a subsequent evaluative trial. Trial Registration: We did not register this study on clinicaltrials.gov because the purpose of the study was to assess the feasibility and acceptability of the intervention and study procedures and measures in preparation for a future trial. The purpose of that future trial will be to evaluate the effect of the intervention on health-related biomedical and behavioral outcomes and that trial will be registered accordingly.

Rationale, design, and recruitment outcomes for the Family/Friend Activation to Motivate Self-care (FAMS) 2.0 randomized controlled trial among adults with type 2 diabetes and their support persons.

BACKGROUND: Self-care behaviors help reduce hemoglobin A1c (HbA1c) and prevent or delay type 2 diabetes (T2D) complications. Individualized interventions that support goal setting and self-monitoring improve self-care and HbA1c in the short-term; engaging family and friends may enhance and/or sustain effects. Family/Friend Activation to Motivate Self-care (FAMS) is a mobile phone-delivered intervention (i.e., phone coaching and text message support) based on Family Systems Theory which was successfully piloted among diverse adults with T2D. METHODS: We made improvements to FAMS and conducted iterative usability testing to finalize FAMS 2.0 before evaluation in a randomized controlled trial (RCT). Adult persons with diabetes (PWDs) who enrolled were asked to invite a support person (friend or family member) to participate alongside them. For the RCT, dyads were randomly assigned to FAMS 2.0 or enhanced treatment as usual (control) for the first 9 months of the 15-month trial. Outcomes include PWDs' HbA1c and psychosocial well-being (including diabetes distress) and support persons' own diabetes distress and support burden. RESULTS: We recruited RCT participants from April 2020 through October 2021 (N = 338 PWDs with T2D; 89% [n = 300] with a support person). PWDs were 52% male, 62% non-Hispanic White, aged 56.9 ± 11.0 years with HbA1c 8.7% ± 1.7% at enrollment; 73% cohabitated with their enrolled support person. Data collection is ongoing through January 2023. CONCLUSION: Findings will inform the utility of engaging family/friends in self-care behaviors for both PWD and support person outcomes. Using widely available mobile phone technology, FAMS 2.0, if successful, has potential for scalability. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04347291 posted April 15, 2020.

mHealth Interventions for Disadvantaged and Vulnerable People with Type 2 Diabetes.

BACKGROUND: Mobile- and Internet-delivered (collectively, digital) interventions are widely used by persons with diabetes (PWD) to assist with self-management and improve/maintain glycemic control (hemoglobin A1c [A1c]). However, evidence concerning the acceptance and benefits of such interventions among disadvantaged/vulnerable PWD is still quite limited. PURPOSE OF REVIEW: We reviewed studies published from 2011-April 2019 evaluating the impact of diabetes self-management interventions delivered via mobile device and/or Internet on glycemic control of disadvantaged/vulnerable adults with type 2 diabetes (T2D). Included studies reported ≥ 50% of the sample having a low socioeconomic status and/or being a racial/ethnic minority, or living in a rural setting or low-/middle-income country (LMIC). We identified 21 studies evaluating a digital intervention among disadvantaged/vulnerable PWD. RECENT FINDINGS: Although many digital interventions found within-group A1c improvements (16 of 21 studies), only seven of the seventeen studies with a control group found between-group differences in A1c. Three studies found reductions in emergency room (ER) visits and hospitalizations. We synthesize this information, and provide recommendations for increasing access, and improving the design and usability of such interventions. We also discuss the role of human support in digital delivery, issues related to study design, reporting, economic value, and available research in LMICs. There is evidence suggesting that digital interventions can improve diabetes control, healthcare utilization, and healthcare costs. More research is needed to substantiate these early findings, and many issues remain in order to optimize the impact of digital interventions on the health outcomes of disadvantaged/vulnerable persons with diabetes.