Glycemic outcomes of a family-focused intervention for adults with type 2 diabetes: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

AIMS: Family/friend Activation to Motivate Self-care (FAMS) is a self-care support intervention delivered via mobile phones. We evaluated FAMS' effects on hemoglobin A1c (HbA1c) and intervention targets among adults with type 2 diabetes in a 15-month RCT. METHODS: Persons with diabetes (PWDs) were randomized to FAMS or control with their support person (family/friend, optional). FAMS included monthly phone coaching and text messages for PWDs, and text messages for support persons over a 9-month intervention period. RESULTS: PWDs (N = 329) were 52 % male, 39 % reported minoritized race or ethnicity, with mean HbA1c 8.6 ± 1.7 %. FAMS improved HbA1c among PWDs with a non-cohabitating support person (-0.64 %; 95 % CI [-1.22 %, -0.05 %]), but overall mean effects were not significant. FAMS improved intervention targets including self-efficacy, dietary behavior, and family/friend involvement during the intervention period; these improvements mediated post-intervention HbA1c improvements (total indirect effect -0.27 %; 95 % CI [-0.49 %, -0.09 %]) and sustained HbA1c improvements at 12 months (total indirect effect -0.19 %; 95 % CI [-0.40 %, -0.01 %]). CONCLUSIONS: Despite improvements in most intervention targets, HbA1c improved only among PWDs engaging non-cohabitating support persons suggesting future family interventions should emphasize inclusion of these relationships. Future work should also seek to identify intervention targets that mediate improvements in HbA1c.

Well-being outcomes of a family-focused intervention for persons with type 2 diabetes and support persons: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

AIMS: Type 2 diabetes self-management occurs within social contexts. We sought to test the effects of Family/friend Activation to Motivate Self-care (FAMS), a self-care support intervention delivered via mobile phones, on psychosocial outcomes for persons with diabetes (PWDs) and their support persons. METHODS: PWDs had the option to enroll with a friend/family member as a support person in a 15-month RCT to evaluate FAMS versus enhanced usual care. FAMS included 9 months of monthly phone coaching and text message support for PWDs, and text message support for enrolled support persons. RESULTS: PWDs (N = 329) were 52% male and 39% reported minoritized race or ethnicity ; 50% enrolled with elevated diabetes distress. Support persons (N = 294) were 26% male and 33% reported minoritized race or ethnicity. FAMS improved PWDs' diabetes distress (d = -0.19) and global well-being (d = 0.21) during the intervention, with patterns of larger effects among minoritized groups. Post-intervention (9-month) and sustained (15-month) improvements were driven by changes in PWDs' self-efficacy, self-care behaviors, and autonomy support. Among support persons, FAMS improved helpful involvement without increasing burden or harmful involvement. CONCLUSIONS: FAMS improved PWDs' psychosocial well-being, with post-intervention and sustained improvements driven by improved self-efficacy, self-care, and autonomy support. Support persons increased helpful involvement without adverse effects.

Well-being outcomes of a family-focused intervention for persons with type 2 diabetes and support persons: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

Aims: Type 2 diabetes self-management occurs within social contexts. We sought to test the effects of Family/friends Activation to Motivate Self-care (FAMS), a self-care support intervention delivered via mobile phones, on psychosocial outcomes for persons with diabetes (PWDs) and their support persons. Methods: PWDs had the option to enroll with a friend/family member as a support person in a 15-month RCT to evaluate FAMS versus enhanced usual care. FAMS included 9-months of monthly phone coaching and text message support for PWDs, and text message support for enrolled support persons. Results: PWDs (N=329) were 52% male and 39% from minoritized racial or ethnic groups; 50% enrolled with elevated diabetes distress. Support persons (N=294) were 26% male and 33% minoritized racial or ethnic groups. FAMS improved PWDs' diabetes distress ( d =-0.19) and global well-being ( d =0.21) during the intervention, with patterns of larger effects among minoritized groups. Post-intervention and sustained (15-month) improvements were driven by changes in PWDs' self-efficacy, self-care behaviors, and autonomy support. Among support persons, FAMS improved helpful involvement without increasing burden or harmful involvement. Conclusions: FAMS improved PWDs' psychosocial well-being, with post-intervention and sustained improvements driven by improved self-efficacy, self-care, and autonomy support. Support persons increased helpful involvement without adverse effects.

Glycemic outcomes of a family-focused intervention for adults with type 2 diabetes: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

Aims: Family/friends Activation to Motivate Self-care (FAMS) is a self-care support intervention delivered via mobile phones. We evaluated FAMS effects on hemoglobin A1c (HbA1c) and intervention targets among adults with type 2 diabetes in a 15-month RCT. Methods: Persons with diabetes (PWDs) and their support persons (family/friend, optional) were randomized to FAMS or control. FAMS included monthly phone coaching and text messages for PWDs, and text messages for support persons over a 9-month intervention period. Results: PWDs (N=329) were 52% male, 39% from minoritized racial or ethnic groups, with mean HbA1c 8.6±1.7%. FAMS improved HbA1c among PWDs with a non-cohabitating support person (-0.64%; 95% CI [-1.22%, -0.05%]), but overall effects were not significant. FAMS improved intervention targets including self-efficacy, dietary behavior, and family/friend involvement during the intervention period; these improvements mediated post-intervention HbA1c improvements (total indirect effect -0.27%; 95% CI [-0.49%, -0.09%]) and sustained HbA1c improvements at 12 months (total indirect effect -0.19%; 95% CI [-0.40%, -0.01%]). Conclusions: Despite improvements in most intervention targets, HbA1c improved only among PWDs engaging non-cohabitating support persons suggesting future family interventions should emphasize inclusion of these relationships. Future work should also seek to identify intervention targets that mediate improvements in HbA1c.

Prerandomization withdrawals from a Type 2 diabetes self-care support intervention trial are associated with lack of available support person coparticipant.

OBJECTIVES: Dyadic interventions, involving two persons with a preexisting close relationship, offer the opportunity to activate support persons (SPs) to improve health for adults with chronic conditions. Requiring SP coparticipation can challenge recruitment and bias samples; however, the associations between voluntary SP coparticipation and recruitment outcomes across patient characteristics are unknown. METHODS: The Family/Friend Activation to Motivate Self-care 2.0 randomized controlled trial (RCT) enrolled adults with Type 2 diabetes (T2D) from an academic health system. Participants were asked-but not required-to invite an SP to coenroll. Using data from the electronic health record we sought to describe RCT enrollment in the setting of voluntary SP coparticipation. RESULTS: In a diverse sample of adults with (T2D) (48% female, 44% minoritized race/ethnicity), most participants (91%) invited SPs and (89%) enrolled with SPs. However, prerandomization withdrawal was significantly higher among participants who did not have consenting SPs than those who did. Females were less likely to invite SPs than males and more Black PWD were prerandomization withdrawals than randomized. DISCUSSION: Voluntary SP coenrollment may benefit recruitment for dyadic sampling; however, more research is needed to understand if these methods systematically bias sampling and to prevent these unintended biases.

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.