Effectiveness of a Health Coaching Intervention for Patient-Family Dyads to Improve Outcomes Among Adults With Diabetes

Abstract

ImportanceMore than 75% of US adults with diabetes do not meet treatment goals. More effective support from family and friends (“supporters”) may improve diabetes management and outcomes.ObjectiveTo determine if the Caring Others Increasing Engagement in Patient Aligned Care Teams (CO-IMPACT) intervention improves patient activation, diabetes management, and outcomes compared with standard care.Design, Setting, and ParticipantsThis randomized clinical trial was conducted from November 2016 to August 2019 among participants recruited from 2 Veterans Health Administration primary care sites. All patient participants were adults aged 30 to 70 years with diabetes who had hemoglobin A1c (HbA1c) levels greater than 8% of total hemoglobin (to convert to proportion of total hemoglobin, multiply by 0.01) or systolic blood pressure (SBP) higher than 150 mm Hg; each participating patient had an adult supporter. Of 1119 recruited, 239 patient-supporter dyads were enrolled between November 2016 and May 2018, randomized 1:1 to receive the CO-IMPACT intervention or standard care, and followed up for 12 to 15 months. Investigators and analysts were blinded to group assignment.InterventionsPatient-supporter dyads received a health coaching session focused on dyadic information sharing and positive support techniques, then 12 months of biweekly automated monitoring telephone calls to prompt dyadic actions to meet diabetes goals, coaching calls to help dyads prepare for primary care visits, and after-visit summaries. Standard-care dyads received general diabetes education materials only.Main Outcomes and MeasuresIntent-to-treat analyses were conducted according to baseline dyad assignment. Primary prespecified outcomes were 12-month changes in Patient Activation Measure–13 (PAM-13) and UK Prospective Diabetes Study (UKPDS) 5-year diabetes-specific cardiac event risk scores. Secondary outcomes included 12-month changes in HbA1c levels, SBP, diabetes self-management behaviors, diabetes distress, diabetes management self-efficacy, and satisfaction with health system support for the involvement of family supporters. Changes in outcome measures between baseline and 12 months were analyzed using linear regression models.ResultsA total of 239 dyads enrolled; among patient participants, the mean (SD) age was 60 (8.9) years, and 231 (96.7%) were male. The mean (SD) baseline HbA1c level was 8.5% (1.6%) and SBP was 140.2 mm Hg (18.4 mm Hg). A total of 168 patients (70.3%) lived with their enrolled supporter; 229 patients (95.8%) had complete 12-month outcome data. In intention-to-treat analyses vs standard care, CO-IMPACT patients had greater 12-month improvements in PAM-13 scores (intervention effect, 2.60 points; 95% CI, 0.02-5.18 points; P = .048) but nonsignificant differences in UKPDS 5-year cardiac risk (intervention effect, 1.01 points; 95% CI, −0.74 to 2.77 points; P = .26). Patients in the CO-IMPACT arm also had greater 12-month improvements in healthy eating (intervention effect, 0.71 d/wk; 95% CI, 0.20-1.22 d/wk; P = .007), diabetes self-efficacy (intervention effect, 0.40 points; 95% CI, 0.09-0.71 points; P = .01), and satisfaction with health system support for the family supporter participants’ involvement (intervention effect, 0.28 points; 95% CI, 0.07-0.49 points; P = .009); however, the 2 arms had similar improvements in HbA1c levels and in other measures.Conclusions and RelevanceIn this randomized clinical trial, the CO-IMPACT intervention successfully engaged patient-supporter dyads and led to improved patient activation and self-efficacy. Physiological outcomes improved similarly in both arms. More intensive direct coaching of supporters, or targeting patients with less preexisting support or fewer diabetes management resources, may have greater impact.Trial RegistrationClinicalTrials.gov Identifier: NCT02328326

Effectiveness of Family-Based Diabetes Management Intervention on Glycated Haemoglobin Among Adults With Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

“…Eighteen RCTs investigated the effects of family diabetes management interventions, employing various approaches and theories. Among these, eight studies were carried out in developed countries: Ireland (Keogh et al, 2011), United States (McEwen et al, 2017; Nelson et al, 2017; Rosal et al, 2011; Rosland et al, 2022; Trief et al, 2016), Republic of China-Taiwan (Kang et al, 2010) and Spain (Coria et al, 2020). Additionally, ten RCTs were implemented in developing countries: Chile (García-Huidobro et al, 2011), Iran (Maslakpak et al, 2017; Tabasi et al, 2014), Brazil (Gomes et al, 2017), Thailand (Poonprapai et al, 2022; Sukchaisong et al, 2022; Wichit et al, 2017; Withidpanyawong et al, 2019), Marshall (McElfish et al, 2019), and Indonesia (Subrata et al, 2020).…”

“…Moreover, the baseline and post-intervention HbA1c levels were measured as the outcome measures. HbA1c values were assessed in six trials after 3 months (Keogh et al, 2011; Maslakpak et al, 2017; Subrata et al, 2020; Sukchaisong et al, 2022; Tabasi et al, 2014; Wichit et al, 2017), four studies after 6 months (García-Huidobro et al, 2011; Gomes et al, 2017; Kang et al, 2010; McEwen et al, 2017), two studies after 9 months (Poonprapai et al, 2022; Withidpanyawong et al, 2019), and six studies after 12 months (Coria et al, 2020; McElfish et al, 2019; Nelson et al, 2017; Rosal et al, 2011; Rosland et al, 2022; Trief et al, 2016).…”

“…Eight studies reported participant’s blinding to treatment assignment (Coria et al, 2020; Gomes et al, 2017; Kang et al, 2010; Keogh et al, 2011; Maslakpak et al, 2017; McElfish et al, 2019; Subrata et al, 2020; Trief et al, 2016); while trainers/counselors were blinded in three studies (Subrata et al, 2020; Sukchaisong et al, 2022; Withidpanyawong et al, 2019). Moreover, 12 studies blinded the assessors (Coria et al, 2020; Kang et al, 2010; Keogh et al, 2011; McElfish et al, 2019; Poonprapai et al, 2022; Rosal et al, 2011; Rosland et al, 2022; Subrata et al, 2020; Sukchaisong et al, 2022; Trief et al, 2016; Wichit et al, 2017; Withidpanyawong et al, 2019). In most studies, single-blind methods were used for participants, trainers, and assessors.…”

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

“…FAMS’ null mean effects on HbA1c are consistent with the broader literature on family-focused interventions. In a recent trial evaluating another family-focused intervention among adults with type 2 diabetes, Rosland et al [22] also found improved self-efficacy and self-care behaviors, but not HbA1c. In Zhang et al’s 2021 meta-analysis of family-based interventions for adults with diabetes, there was an overall effect on HbA1c, but the effect was much larger when the length of follow-up was 6 months or less [45].…”

“…There is also limited understanding of factors that might explain effects of family-focused interventions on HbA1c [17 20 21]. Although past studies have shown that family-focused interventions lead to improvements in self-efficacy and self-care [15 22], it is not clear whether these factors drive improvements in HbA1c. Furthermore, it remains unclear if improvements in family/friend involvement drive improvements in HbA1c.…”