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临床试验/NCT04738591
NCT04738591已完成不适用

Feasibility Study Through a Phase II Randomized Clinical Trial of an Intervention Based on Short Message System (SMS) to Promote Adherence to Antidiabetic Medication and Healthy Lifestyles in Patients With Type 2 Diabetes Mellitus

Fundació d'investigació Sanitària de les Illes Balears2 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2020年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
207
试验地点
2
主要终点
Glycated Hemoglobin (HbA1C)

研究概览

简要总结

This study aims at evaluating the feasibility of an intervention based on the use of a mobile-device based system delivering automated, tailored brief text messages to offer support for medicine use and lifestyle recommendations alongside usual care to people with type 2 diabetes.

详细描述

A list of patients registered in primary care centers of the Balearic Islands and potentially meeting the eligibility criteria will be obtained from electronic health records (EHRs). A research assistant will contact the potential participants via phone to invite them to the study and confirm eligibility. All eligible participants will complete informed consent followed by baseline assessment over the phone before randomization. Participants will be randomly allocated using a computer-generated randomization sequence. All participants will continue with their usual diabetes care including all medical visits, tests, and diabetes support programs throughout the study. In addition, the intervention group will receive the text messaging intervention. Control participants will receive usual care only. After three months of follow-up, all participants will complete post-intervention assessments via phone interview. Data on glycemic control (HbA1c) at baseline and post-intervention will be extracted from EHRs, as according to the protocol used for primary care providers in the Balearic Islands, patients with poor glycemic control (HbA1c >8% ) must request an HbA1c determination every six months. Results of the most recent determination will be extracted from electronic medical records. For those patients with no recorded HbA1c within the previous three months, the research assistant will contact the primary care center and the patient to arrange blood test analyses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients registered in the Public Health Service of the Balearic Islands
  • With type 2 diabetes
  • At least one prescription of an oral glucose-lowering drug
  • With results of HbA1C>8% from 3 months prior to recruitment.

排除标准

  • Younger than 18 years old
  • With insulin treatment.

结局指标

主要结局

Glycated Hemoglobin (HbA1C)

时间窗: Baseline and post-intervention at 3 months

HbA1c was extracted as percentage which is calculated following the standard formulae \[HbA1c(%)=(HbA1c(mmol/mol)+23.5)/10.93\] based on its concentration in blood samples. It identifies average plasma glucose concentration.

次要结局

  • Number of Participants Classified as Adherent Based on Self-reporteAdherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire)(Baseline and post-intervention at 3 months)
  • Enrolment or Recruitment Rate(Baseline)
  • Retention Rate(3 months)

研究者

发起方
Fundació d'investigació Sanitària de les Illes Balears
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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