一项针对 2 型糖尿病成人患者的电话传递依从性疗法可行性试验的研究方案。
A study protocol for a feasibility trial of telephone-delivered Adherence Therapy for adults with type 2 diabetes.
机构信息
College of Science Health and Engineering, La Trobe University, Bundoora, VIC, Australia.
Department of Public Health, College of Public Health and Health Informatics, Qassim University, AlBukayriyah, Saudi Arabia.
出版信息
Nurs Open. 2021 May;8(3):1510-1519. doi: 10.1002/nop2.735. Epub 2021 Jan 20.
AIMS
Adherence therapy is a candidate intervention to improve medication adherence and clinical outcomes in patients with type 2 diabetes. The feasibility of conducting a trial of adherence therapy in this population has not been established. The objective of this study is therefore to test the feasibility of conducting a randomized controlled trial of adherence therapy in a Middle Eastern context.
DESIGN
A single-centre randomized controlled feasibility trial of adherence therapy in patients with type 2 diabetes.
METHODS
We will undertake an initial cultural adaptation of a telephone-delivered form of adherence therapy in four patients in a Middle Eastern context. Our subsequent feasibility trial will aim to recruit 40 non-adherent diabetic patients that will be randomly allocated to receive eight weekly 30-min telephone adherence therapy sessions delivered by a diabetes educator versus treatment as usual. Key outcomes of interest include the number of patients invited to take part in the trial that consent to participate and then go on to complete treatment.
RESULT
The findings of this study will determine the feasibility of undertaking a full randomized controlled trial of adherence therapy in patients with type 2 diabetes.
目的
依从性治疗是一种改善 2 型糖尿病患者药物依从性和临床结局的候选干预措施。在该人群中开展依从性治疗试验的可行性尚未确定。因此，本研究的目的是检验在中东背景下开展依从性治疗随机对照试验的可行性。
设计
在中东地区，对 2 型糖尿病患者进行依从性治疗的单中心随机对照可行性试验。
方法
我们将在中东地区的 4 名患者中，对电话传递形式的依从性治疗进行初步的文化适应性调整。我们随后的可行性试验将旨在招募 40 名不依从的糖尿病患者，他们将被随机分配接受 8 周每周 30 分钟的糖尿病教育者提供的电话依从性治疗，与常规治疗相比。主要观察指标包括邀请参加试验的患者人数、同意参加试验然后继续完成治疗的患者人数。
结果
本研究的结果将确定在 2 型糖尿病患者中开展依从性治疗的随机对照试验的可行性。
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