一项基于数字健康和社区药房的生活方式干预计划，用于治疗成年人前驱糖尿病：一项基于群组的随机对照试验研究方案。

A digital health-supported and community pharmacy-based lifestyle intervention program for adults with pre-diabetes: a study protocol for a cluster randomised controlled trial.

机构信息

School of Pharmacy, Monash University Malaysia, Subang Jaya, Selangor, Malaysia.

Pharmacy Practice Department, CARiNG Pharmacy Head Office, Petaling Jaya, Selangor, Malaysia.

出版信息

BMJ Open. 2024 Oct 23;14(10):e083921. doi: 10.1136/bmjopen-2024-083921.

DOI:10.1136/bmjopen-2024-083921

PMID:39448216

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11579589/

Abstract

INTRODUCTION

Pre-diabetes indicates an elevated risk of developing type-2 diabetes and presents a window for preventive actions. The Pre-diabetes Intervention, Management and Evaluation (PRIME) programme is a community pharmacy-based pre-diabetes management programme that uses a mobile application for self-monitoring and pre-diabetes education, aiming to promote lifestyle changes among participants with pre-diabetes.

METHODS AND ANALYSIS

This is a protocol for a cluster randomised controlled trial that aims to evaluate the impact of the PRIME programme on participants' clinical outcomes and explore participants' and pharmacists' views towards its implementation. This protocol describes the development of the PRIME programme and mobile app, its feasibility and implementation in community pharmacy settings. 16 pharmacies from two states in Malaysia will be randomised to the intervention arm or standard care. The study will include overweight or obese adults with pre-diabetes. During each follow-up visit at the pharmacy, intervention participants will receive in-depth counselling from pharmacists after reviewing their self-monitoring data recorded in the PRIME app. They will also receive pre-diabetes education through the app and join a peer support chatgroup. The primary clinical outcome includes changes in body weight at 6 months, while the secondary clinical outcomes include changes in blood glucose profile, lipid profile, blood pressure and adiposity measures. The sustainability of the PRIME programme will be accessed using a follow-up questionnaire, while participants' engagement with the intervention will be evaluated using attendance rate and the app data. Focus group discussions and one-to-one interviews will be conducted for process evaluation. This study will inform the impact of community pharmacists-led digital health intervention in pre-diabetes management.

ETHICS AND DISSEMINATION

This study has been registered with clinicaltrials.gov (NCT04832984) and approved by the Monash University Human Research Ethics Committee (Project ID: 27512).

TRIAL REGISTRATION NUMBER

clinicaltrials.gov (NCT04832984).

摘要

简介

糖尿病前期表示发生 2 型糖尿病的风险增加，并提供了采取预防措施的机会。糖尿病前期干预、管理和评估（PRIME）计划是一个基于社区药房的糖尿病前期管理计划，它使用移动应用程序进行自我监测和糖尿病前期教育，旨在促进有糖尿病前期的参与者改变生活方式。

方法和分析

这是一项群组随机对照试验的方案，旨在评估 PRIME 计划对参与者临床结果的影响，并探讨参与者和药剂师对其实施的看法。本方案描述了 PRIME 计划和移动应用程序的开发、它在社区药房环境中的可行性和实施情况。马来西亚两个州的 16 家药店将被随机分配到干预组或标准护理组。该研究将包括超重或肥胖的糖尿病前期成年人。在药房的每次随访中，干预组参与者将在查看他们在 PRIME 应用程序中记录的自我监测数据后，接受药剂师的深入咨询。他们还将通过应用程序接受糖尿病前期教育，并加入同伴支持聊天小组。主要临床结果包括 6 个月时体重的变化，次要临床结果包括血糖谱、血脂谱、血压和肥胖指标的变化。使用后续问卷调查评估 PRIME 计划的可持续性，使用出席率和应用程序数据评估参与者对干预措施的参与度。将进行焦点小组讨论和一对一访谈以进行过程评估。本研究将为社区药剂师主导的数字健康干预在糖尿病前期管理中的影响提供信息。