Frosch Dominick L, Uy Visith, Ochoa Socorro, Mangione Carol M
Department of Health Services Research, Palo Alto Medical Foundation Research Institute, Palo Alto, CA 94301, USA.
Arch Intern Med. 2011 Dec 12;171(22):2011-7. doi: 10.1001/archinternmed.2011.497. Epub 2011 Oct 10.
Disease management programs that include ongoing telephone support for patients with diabetes have shown promise, but published studies have enrolled few socially and economically disadvantaged patients.
We conducted a randomized controlled trial with 201 patients with poorly controlled type 2 diabetes mellitus (72% African American or Latino; 74% with incomes of ≤$15,000). Participants were randomized to an intervention package consisting of a 24-minute video behavior support intervention with a workbook and 5 sessions of telephone coaching by a trained diabetes nurse or a 20-page brochure developed by the National Diabetes Education Program. Study measures were completed at baseline, 1 month, and 6 months. Participants' review of the intervention materials was assessed at 1 month. The primary trial end point was hemoglobin A(1c) value. Secondary end points included lipid levels, blood pressure, diabetes knowledge, and self-care behaviors. Data were analyzed with repeated measures analysis of variance.
Most participants in both groups (94%) reviewed the intervention provided, and 73% of participants assigned to the experimental group completed 5 sessions of telephone coaching. There was a significant overall reduction in mean (SD) hemoglobin A(1c) value from baseline (9.6% [2.0%]) to 6 months (9.1% [1.9%]) (P < .001), but differences between groups were nonsignificant. Differences on other clinical measures (lipid levels and blood pressure) and measures of diabetes knowledge and self-care behaviors were also nonsignificant.
There was no significant effect of the experimental intervention compared with the control condition. The dose of intervention provided was less than in previously published studies. More intensive interventions may be necessary for the most disadvantaged patients.
clinicaltrials.gov Identifier: NCT00668590.
针对糖尿病患者的疾病管理项目，若包含持续的电话支持，已显示出前景，但已发表的研究纳入的社会经济弱势患者较少。
我们对201例2型糖尿病控制不佳的患者进行了一项随机对照试验（72%为非裔美国人或拉丁裔；74%收入≤15,000美元）。参与者被随机分为两组，一组接受由一本工作手册和5次由经过培训的糖尿病护士进行的电话指导组成的24分钟视频行为支持干预，另一组接受由国家糖尿病教育项目编写的20页宣传册。研究指标在基线、1个月和6个月时完成。在1个月时评估参与者对干预材料的阅读情况。主要试验终点是糖化血红蛋白A1c值。次要终点包括血脂水平、血压、糖尿病知识和自我护理行为。数据采用重复测量方差分析进行分析。
两组中的大多数参与者（94%）阅读了所提供的干预内容，分配到实验组的参与者中有73%完成了5次电话指导。从基线时的平均（标准差）糖化血红蛋白A1c值（9.6% [2.0%]）到6个月时（9.1% [1.9%]）有显著的总体降低（P <.001），但两组之间的差异不显著。其他临床指标（血脂水平和血压）以及糖尿病知识和自我护理行为指标的差异也不显著。
与对照条件相比，实验性干预没有显著效果。所提供的干预剂量低于先前发表的研究。对于最弱势的患者，可能需要更强化的干预。
clinicaltrials.gov标识符：NCT00668590。
