一项旨在提高 2 型糖尿病患者口服抗糖尿病和/或抗高血压药物依从性的个体化干预方案，INTENSE 研究：一项随机对照试验的研究方案。

A personalised intervention programme aimed at improving adherence to oral antidiabetic and/or antihypertensive medication in people with type 2 diabetes mellitus, the INTENSE study: study protocol for a randomised controlled trial.

机构信息

Amsterdam UMC location Vrije Universiteit Amsterdam, Department of General Practice, Boelelaan 1117, Amsterdam, The Netherlands.

Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.

出版信息

Trials. 2022 Sep 2;23(1):731. doi: 10.1186/s13063-022-06491-7.

DOI:10.1186/s13063-022-06491-7

PMID:36056388

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9438235/

Abstract

BACKGROUND

Medication non-adherence is a prevalent health problem in people with type 2 diabetes mellitus (T2DM). Interventions have previously been developed to improve medication adherence, but inconsistent outcomes have been reported. A potential explanation for this inconsistency is a 'one size fits all' approach, with interventions not tailored to the needs and preferences of individuals. Therefore, the aim of this study is to evaluate the effectiveness of a personalised intervention programme aimed at improving adherence to oral antidiabetic and/or antihypertensive medication in people with T2DM.

METHODS

A parallel-group randomised controlled trial will be conducted in 40-50 community pharmacies in the Netherlands and the United Kingdom (UK). A total of 300 participants will be included and followed up for a period of 6 months. Participants will be people with T2DM identified as non-adherent to oral antidiabetic and/or antihypertensive medication, aged 35-75 years and mobile phone users. The intervention group will receive a personalised intervention programme that is based on one or more of the participants' pre-defined non-adherence profile(s), namely (I) Knowledge and perceptions, (II) Practical problems, (III) Side effects and (IV) Negative mood and beliefs. The intervention comprises of one or more supporting modules, namely (I) Brief messaging, (II) Clinical medication review, (III) Medication schedule, (IV) Reminding messaging, (V) Medication dispensing systems, (VI) Smart messaging, (VII) Referral to general practitioner and (VIII) Unguided web-based Self Help Application for low mood. The control group will receive usual care including access to a publicly available informative diabetes website. The primary study outcome is medication adherence measured with a telephone pill count. Secondary outcomes are systolic blood pressure, HbA1c level, self-reported medication adherence, attitude and beliefs toward medication, satisfaction with diabetes treatment, health status and medical consumption and productivity cost. In addition, a process evaluation will be undertaken to establish the fidelity, reach and the extent to which intervention delivery is normalised in the daily practice of community pharmacy teams.

DISCUSSION

The study can lead to a personalised intervention programme that improves medication adherence in people with T2DM that are non-adherent to oral antidiabetic and/or antihypertensive medication.

TRIAL REGISTRATION

Dutch Trial Register, Trial NL8747 , registered 02 July, 2020; ISRCTN Registry, ISRCTN36009809 , registered 05 February, 2020.

摘要

背景

药物依从性差是 2 型糖尿病（T2DM）患者中普遍存在的健康问题。之前已经开发了干预措施来提高药物依从性，但报告的结果不一致。这种不一致的一个潜在解释是“一刀切”的方法，干预措施没有针对个人的需求和偏好进行定制。因此，本研究的目的是评估针对 T2DM 患者口服抗糖尿病和/或抗高血压药物依从性差的个性化干预方案的有效性。

方法

将在荷兰和英国的 40-50 家社区药房进行一项平行组随机对照试验。将纳入 300 名参与者，并随访 6 个月。参与者为被确定为口服抗糖尿病和/或抗高血压药物不依从的 T2DM 患者，年龄 35-75 岁，且为手机使用者。干预组将接受基于参与者一个或多个预先确定的不依从档案的个性化干预方案，即（一）知识和认知，（二）实际问题，（三）副作用和（四）负面情绪和信念。干预包括一个或多个支持模块，即（一）短信，（二）临床药物审查，（三）药物时间表，（四）提醒短信，（五）药物分发系统，（六）智能短信，（七）转介给全科医生和（八）用于低情绪的无指导网络自助应用程序。对照组将接受常规护理，包括访问一个公开的糖尿病信息网站。主要研究结果是通过电话计数测量的药物依从性。次要结果是收缩压、HbA1c 水平、自我报告的药物依从性、对药物的态度和信念、对糖尿病治疗的满意度、健康状况和医疗消费以及生产力成本。此外，还将进行过程评估，以确定社区药房团队日常实践中的干预措施的保真度、可达性以及干预措施交付的正常化程度。