Gimbel Ronald W, Rennert Lior M, Crawford Paul, Little Jeanette R, Truong Khoa, Williams Joel E, Griffin Sarah F, Shi Lu, Chen Liwei, Zhang LingLing, Moss Jennie B, Marshall Robert C, Edwards Karen W, Crawford Kristy J, Hing Marie, Schmeltz Amanda, Lumsden Brandon, Ashby Morgan, Haas Elizabeth, Palazzo Kelly
Department of Public Health Sciences, Clemson University, Clemson, SC, United States.
Nellis Family Medicine Residency Program, Mike O'Callaghan Federal Hospital, Las Vegas, NV, United States.
J Med Internet Res. 2020 May 26;22(5):e17968. doi: 10.2196/17968.
Past mobile health (mHealth) efforts to empower type 2 diabetes (T2D) self-management include portals, text messaging, collection of biometric data, electronic coaching, email, and collection of lifestyle information.
The primary objective was to enhance patient activation and self-management of T2D using the US Department of Defense's Mobile Health Care Environment (MHCE) in a patient-centered medical home setting.
A multisite study, including a user-centered design and a controlled trial, was conducted within the US Military Health System. Phase I assessed preferences regarding the enhancement of the enabling technology. Phase II was a single-blinded 12-month feasibility study that randomly assigned 240 patients to either the intervention (n=123, received mHealth technology and behavioral messages tailored to Patient Activation Measure [PAM] level at baseline) or the control group (n=117, received equipment but not messaging. The primary outcome measure was PAM scores. Secondary outcome measures included Summary of Diabetes Self-Care Activities (SDSCA) scores and cardiometabolic outcomes. We used generalized estimating equations to estimate changes in outcomes.
The final sample consisted of 229 patients. Participants were 61.6% (141/229) male, had a mean age of 62.9 years, mean glycated hemoglobin (HbA) of 7.5%, mean BMI of 32.7, and a mean duration of T2D diagnosis of 9.8 years. At month 12, the control group showed significantly greater improvements compared with the intervention group in PAM scores (control mean 7.49, intervention mean 1.77; P=.007), HbA (control mean -0.53, intervention mean -0.11; P=.006), and low-density lipoprotein cholesterol (control mean -7.14, intervention mean 4.38; P=.01). Both groups showed significant improvement in SDSCA, BMI, waist size, and diastolic blood pressure; between-group differences were not statistically significant. Except for patients with the highest level of activation (PAM level 4), intervention group patients exhibited significant improvements in PAM scores. For patients with the lowest level of activation (PAM level 1), the intervention group showed significantly greater improvement compared with the control group in HbA (control mean -0.09, intervention mean -0.52; P=.04), BMI (control mean 0.58, intervention mean -1.22; P=.01), and high-density lipoprotein cholesterol levels (control mean -4.86, intervention mean 3.56; P<.001). Significant improvements were seen in AM scores, SDSCA, and waist size for both groups and in diastolic and systolic blood pressure for the control group; the between-group differences were not statistically significant. The percentage of participants who were engaged with MHCE for ≥50% of days period was 60.7% (68/112; months 0-3), 57.4% (62/108; months 3-6), 49.5% (51/103; months 6-9), and 43% (42/98; months 9-12).
Our study produced mixed results with improvement in PAM scores and outcomes in both the intervention and control groups. Structural design issues may have hampered the influence of tailored behavioral messaging within the intervention group.
ClinicalTrials.gov NCT02949037; https://clinicaltrials.gov/ct2/show/NCT02949037.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.6993.
过去为增强2型糖尿病（T2D）自我管理能力而开展的移动健康（mHealth）工作包括门户网站、短信、生物特征数据收集、电子辅导、电子邮件以及生活方式信息收集。
主要目的是在美国国防部移动医疗环境（MHCE）的以患者为中心的医疗之家环境中，增强T2D患者的自我管理能力和激活水平。
在美国军事医疗系统内开展了一项多中心研究，包括以用户为中心的设计和一项对照试验。第一阶段评估了关于增强支持技术的偏好。第二阶段是一项单盲的12个月可行性研究，将240名患者随机分为干预组（n = 123，接受mHealth技术以及根据基线时患者激活度量表[PAM]水平定制的行为信息）或对照组（n = 117，接受设备但不接收信息）。主要结局指标是PAM得分。次要结局指标包括糖尿病自我护理活动总结（SDSCA）得分和心脏代谢指标。我们使用广义估计方程来估计结局的变化。
最终样本包括229名患者。参与者中61.6%（141/229）为男性，平均年龄62.9岁，平均糖化血红蛋白（HbA）为7.5%，平均体重指数（BMI）为32.7，T2D诊断的平均时长为9.8年。在第12个月时，对照组在PAM得分（对照组均值7.49，干预组均值1.77；P = .007）、HbA（对照组均值 -0.53，干预组均值 -0.11；P = .006）和低密度脂蛋白胆固醇（对照组均值 -7.14，干预组均值4.38；P = .01）方面的改善显著大于干预组。两组在SDSCA、BMI、腰围和舒张压方面均有显著改善；组间差异无统计学意义。除激活水平最高（PAM水平4）的患者外，干预组患者的PAM得分有显著改善。对于激活水平最低（PAM水平1）的患者，干预组在HbA（对照组均值 -0.09，干预组均值 -0.52；P = .04）、BMI（对照组均值0.58，干预组均值 -1.22；P = .01）和高密度脂蛋白胆固醇水平（对照组均值 -4.86，干预组均值3.56；P < .001）方面的改善显著大于对照组。两组在AM得分、SDSCA和腰围方面均有显著改善，对照组在舒张压和收缩压方面也有显著改善；组间差异无统计学意义。在0 - 3个月期间，使用MHCE≥50%天数的参与者比例为60.7%（68/112），3 - 6个月为57.4%（62/108），6 - 9个月为49.5%（51/103），9 - 12个月为43%（42/98）。
我们的研究结果喜忧参半，干预组和对照组的PAM得分及结局均有改善。结构设计问题可能阻碍了干预组中定制行为信息的影响。
ClinicalTrials.gov NCT02949037；https://clinicaltrials.gov/ct2/show/NCT02949037。
国际注册报告标识符（IRRID）：RR2 - 10.2196/resprot.6993。
