Center for Health Equity Research and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania.
Department of Internal Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.
JAMA Netw Open. 2022 Nov 1;5(11):e2237960. doi: 10.1001/jamanetworkopen.2022.37960.
More 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.
To 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 PARTICIPANTS: This 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.
Patient-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.
Intent-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.
A 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.
In 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.
ClinicalTrials.gov Identifier: NCT02328326.
重要性：超过 75% 的美国成年糖尿病患者未达到治疗目标。来自家人和朋友（“支持者”）的更有效的支持可能会改善糖尿病的管理和结果。
目的：确定与标准护理相比，关爱他人增加患者与护理团队的参与度（CO-IMPACT）干预是否能改善患者的积极性、糖尿病管理和结果。
设计、地点和参与者：这是一项随机临床试验，于 2016 年 11 月至 2019 年 8 月在退伍军人健康管理局的两个初级保健点招募参与者。所有患者参与者均为年龄在 30 至 70 岁之间的成年人，糖化血红蛋白（HbA1c）水平高于总血红蛋白的 8%（要转换为总血红蛋白的比例，请将其乘以 0.01）或收缩压（SBP）高于 150 毫米汞柱；每位参与的患者都有一位成年支持者。在招募的 1119 人中，2016 年 11 月至 2018 年 5 月期间有 239 对患者-支持者二人组被随机分为 1:1 组，分别接受 CO-IMPACT 干预或标准护理，并随访 12 至 15 个月。研究人员和分析人员对分组情况不知情。
干预措施：患者-支持者二人组接受了一次健康辅导会议，重点是二人组信息共享和积极支持技巧，然后是 12 个月的每两周一次的自动监测电话，以促使二人组采取行动达到糖尿病目标，辅导电话帮助二人组为初级保健就诊做准备，以及就诊后总结。标准护理二人组仅接受一般糖尿病教育材料。
主要结果和措施：根据基线二人组分配进行意向治疗分析。主要预先指定的结果是 12 个月时患者积极性测量-13（PAM-13）和英国前瞻性糖尿病研究（UKPDS）5 年糖尿病特定心脏事件风险评分的变化。次要结果包括 12 个月时糖化血红蛋白水平、SBP、糖尿病自我管理行为、糖尿病困扰、糖尿病管理自我效能和对健康系统支持家庭支持者参与的满意度的变化。使用线性回归模型分析基线和 12 个月之间的结果测量变化。
结果：共有 239 对二人组入组；患者参与者的平均（SD）年龄为 60（8.9）岁，96.7%（231 人）为男性。平均（SD）基线糖化血红蛋白水平为 8.5%（1.6%），收缩压为 140.2 毫米汞柱（18.4 毫米汞柱）。共有 168 名患者（70.3%）与他们登记的支持者同住；229 名患者（95.8%）有完整的 12 个月结果数据。在意向治疗分析中，与标准护理相比，CO-IMPACT 患者的 PAM-13 评分在 12 个月时改善更大（干预效果，2.60 分；95%置信区间，0.02-5.18 分；P=0.048），但 UKPDS 5 年心脏风险无显著差异（干预效果，1.01 分；95%置信区间，-0.74 至 2.77 分；P=0.26）。CO-IMPACT 组的患者在 12 个月时也有更大的改善，包括更健康的饮食（干预效果，每周 0.71 天；95%置信区间，0.20-1.22 天；P=0.007）、糖尿病自我效能（干预效果，0.40 分；95%置信区间，0.09-0.71 分；P=0.01）和对健康系统支持家庭支持者参与的满意度（干预效果，0.28 分；95%置信区间，0.07-0.49 分；P=0.009）；然而，两组在糖化血红蛋白水平和其他测量指标上的改善相似。
结论和相关性：在这项随机临床试验中，CO-IMPACT 干预成功地使患者-支持者二人组参与，并导致患者积极性和自我效能的提高。生理结果在两组中均有类似的改善。更密集的直接支持者辅导，或针对支持较少或糖尿病管理资源较少的患者，可能会产生更大的影响。
试验注册：ClinicalTrials.gov 标识符：NCT02328326。
