A Randomised Controlled Trial to Evaluate the Impact of Supportive Text Messages From GP Practices on Self-reported Symptoms and Inhaler Adherence in Patients With Asthma and/or Chronic Obstructive Pulmonary Disease (COPD) Who Have Been Prescribed a Preventer (Daily) Inhaler (Inhaler Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Accurx
- 入组人数
- 6,053
- 试验地点
- 13
- 主要终点
- Improved self-reported medication taking as measured by the The Medication Adherence Report Scale (MARS-5) Questionnaire
研究概览
简要总结
A 6-month randomised controlled trial to evaluate the impact of text message support on symptom control and inhaler adherence for patients with asthma and/or COPD
详细描述
This trial will be a 6-month prospective, randomised controlled trial in which the study population is randomly allocated (1:1) to an intervention or control group. The trial is multicentre and is non-blind. All patients in both groups will continue to receive their usual care for the duration of the study. Randomisation will be at the individual level. Participants will be randomly allocated as per a computer-generated randomisation list using a random number generator as part of the Microsoft .NET framework.
This is a behavioural intervention. The intervention will consist of a series of supportive text messages to patients from their GP practice over a 6 month period. The messages will vary in frequency from 2 or 3 in the first weeks of the trial to only 1 or 2 a month in the final months of the trial. The content of the messages will vary; some will contain information about how to use a preventer inhaler, some will emphasise the importance of using it, and some will provide simple reminders to patients to take their inhaler.
All participants will continue to receive their usual care throughout the duration of the study; the text message intervention with be in addition to their usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Willing and able to provide informed consent and to comply with the study instructions
- •Male and females age 18 or older
- •Confirmed diagnosis of asthma and/or COPD as recorded in the patient's GP medical record
- •Currently prescribed a preventer inhaler
- •Access to a mobile phone
- •Ability to check text messages on phone
- •Ability to read
排除标准
- •Inability to understand the study procedures
- •Inability or reluctance to provide responses to the study questionnaires
- •Inability to receive and respond to text messages
结局指标
主要结局
Improved self-reported medication taking as measured by the The Medication Adherence Report Scale (MARS-5) Questionnaire
时间窗: Baseline to 13 and 26 weeks
Changes in the MARS-5 Questionnaire
次要结局
- A reduction in the interval between patients requesting preventer inhaler prescriptions(Baseline to 13 and 26 weeks)
- Improved control of asthma symptoms as measured by the Asthma Control Test(Baseline to 13 and 26 weeks (for asthma patients))
- Difference in emergency admissions(Over 26 weeks)
- Differences in NHS utilisation(Over 26 weeks)