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联合健康专业人员的简短咨询对外周动脉疾病患者步数的影响
T2 -一项随机临床试验
高利奇，乔纳森
AU - Yip, Lisan
AU - Venn, Alkira
安东尼·雷赫特。
杰森·詹金斯
菲亚托罗内·辛格，玛拉·A
AU - Reid, Christopher
AU - Ademi, Zanfina
AU - Parmenter, Belinda J。
约瑟夫·莫克森
妮可拉·W·奥·伯顿著
AU -为BIP调查员
版权所有:©2023美国医学协会。版权所有。
Py - 2023/4
Y1 - 2023/4
重要性:目前尚不清楚如何有效促进外周动脉疾病(PAD)患者的行走。目的:测试联合卫生专业人员提供的简短咨询是否会增加PAD患者的步数。设计、环境和参与者:在这项随机临床试验中，有症状的PAD参与者从澳大利亚的站点招募，并随机按1:1分配到咨询干预组或注意控制组。数据收集时间为2015年1月至2021年7月，数据分析时间为2022年3月至11月。干预措施:两次1小时的面对面和两次15分钟的电话咨询，旨在增加步行量。主要结局和测量:主要结局是在基线和4个月的7天和加速度计记录中估计的每日步数变化的组间差异，使用缺失值的代入。4、12和24个月时的其他结果包括步数、6分钟步行距离、疾病特异性和与健康相关的生活质量的一般测量。在24个月内评估主要肢体不良事件的风险。结果:纳入的200名受试者中，144名(72.0%)为男性，平均(SD)年龄为69.2(9.3)岁。200名参与者的计划样本被分配到咨询干预组(n = 102)和注意对照组(n = 98)。 Overall, 198 (99.0%), 175 (87.5%), 160 (80.0%) and 143 (71.5%) had step count assessed at entry and 4, 12, and 24 months, respectively. There was no significant between-group difference in the primary outcome of change in daily step count over 4 months (mean steps, 415; 95% CI, -62 to 893; P =.07). Participants in the counseling group had significantly greater improvement in the secondary outcome of disease-specific Intermittent Claudication Questionnaire score at 4 months (3.2 points; 95% CI, 0.1-6.4; P =.04) and 12 months (4.3 points; 95% CI, 0.5-8.1; P =.03) but not at 24 months (1.2 points; 95% CI, -3.1 to 5.6; P =.57). Findings were similar for mean PAD Quality of Life Questionnaire component assessing symptoms and limitations in physical functioning (4 months: 1.5 points; 95% CI, 0.3-2.8; P =.02; 12 months: 1.8 points; 95% CI, 0.3-3.3; P =.02; 24 months: 1.3 points; 95% CI. -0.5 to 3.1; P =.16). There was no significant effect of the intervention on change in mean 6-minute walking distance (4 months: 9.3 m; 95% CI, -3.7 to 22.3; P =.16; 12 months: 13.8 m; 95% CI, -4.2 to 31.7; P =.13; 24 months: 1.2 m; 95% CI, -20.0 to 22.5; P =.91). The counseling intervention did not affect the rate of major adverse limb events over 24 months (12 [6.0%] in the intervention group vs 11 [5.5%] in the control group; P >.99). Conclusions and Relevance: This randomized clinical trial found no significant effect of brief counseling on step count in people with PAD. Alternate interventions are needed to enable walking. Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614000592640.
重要性:目前尚不清楚如何有效促进外周动脉疾病(PAD)患者的行走。目的:测试联合卫生专业人员提供的简短咨询是否会增加PAD患者的步数。设计、环境和参与者:在这项随机临床试验中，有症状的PAD参与者从澳大利亚的站点招募，并随机按1:1分配到咨询干预组或注意控制组。数据收集时间为2015年1月至2021年7月，数据分析时间为2022年3月至11月。干预措施:两次1小时的面对面和两次15分钟的电话咨询，旨在增加步行量。主要结局和测量:主要结局是在基线和4个月的7天和加速度计记录中估计的每日步数变化的组间差异，使用缺失值的代入。4、12和24个月时的其他结果包括步数、6分钟步行距离、疾病特异性和与健康相关的生活质量的一般测量。在24个月内评估主要肢体不良事件的风险。结果:纳入的200名受试者中，144名(72.0%)为男性，平均(SD)年龄为69.2(9.3)岁。200名参与者的计划样本被分配到咨询干预组(n = 102)和注意对照组(n = 98)。 Overall, 198 (99.0%), 175 (87.5%), 160 (80.0%) and 143 (71.5%) had step count assessed at entry and 4, 12, and 24 months, respectively. There was no significant between-group difference in the primary outcome of change in daily step count over 4 months (mean steps, 415; 95% CI, -62 to 893; P =.07). Participants in the counseling group had significantly greater improvement in the secondary outcome of disease-specific Intermittent Claudication Questionnaire score at 4 months (3.2 points; 95% CI, 0.1-6.4; P =.04) and 12 months (4.3 points; 95% CI, 0.5-8.1; P =.03) but not at 24 months (1.2 points; 95% CI, -3.1 to 5.6; P =.57). Findings were similar for mean PAD Quality of Life Questionnaire component assessing symptoms and limitations in physical functioning (4 months: 1.5 points; 95% CI, 0.3-2.8; P =.02; 12 months: 1.8 points; 95% CI, 0.3-3.3; P =.02; 24 months: 1.3 points; 95% CI. -0.5 to 3.1; P =.16). There was no significant effect of the intervention on change in mean 6-minute walking distance (4 months: 9.3 m; 95% CI, -3.7 to 22.3; P =.16; 12 months: 13.8 m; 95% CI, -4.2 to 31.7; P =.13; 24 months: 1.2 m; 95% CI, -20.0 to 22.5; P =.91). The counseling intervention did not affect the rate of major adverse limb events over 24 months (12 [6.0%] in the intervention group vs 11 [5.5%] in the control group; P >.99). Conclusions and Relevance: This randomized clinical trial found no significant effect of brief counseling on step count in people with PAD. Alternate interventions are needed to enable walking. Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614000592640.
UR - http://www.scopus.com/inward/record.url?scp=85152478090&partnerID=8YFLogxK
U2 - 10.1001/jamacardio.2022.5437
10.1001/jamacardio.2022.5437
M3 -文章
C2 - 36753250
scopus:85152478090
Vl - 8
Sp - 394
Ep - 399
JAMA心脏病学
JAMA心脏病学
Sn - 2380-6583
是- 4
呃- - - - - -