Multicomponent Breathlessness and Physical Activity Intervention in People With Moderate to Severe Asthma Using a Supported Digital Platform
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Asthma Quality of Life Questionnaire (AQLQ)
研究概览
简要总结
Treating breathlessness could help people with asthma have fewer symptoms and be more physically active. People with asthma report that it is important to deal with breathlessness during physical activity programs, but past research hasn't focused on this need.
The investigators have developed a multicomponent digitally supported intervention targeting breathlessness and physical inactivity. This study will test whether the multicomponent digital supported intervention will help people with asthma. The main question the study aims to answer is:
Does the multicomponent digitally supported intervention improve quality of life?
Participants will:
- Be allocated to the intervention or usual care. Allocation to either group will be random (like tossing a coin).
- Attend study visits to complete an assessment involving questionnaires and measurements
- Receive telephone calls to ask questions about health
- Be invited to take part in an interview to have a conversation about thoughts on participating in the study
- Be asked to provide consent to collect information from Services Australia regarding use of health care services and medications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Aged 18 years or older
- •Able to provide informed consent
- •Evidence of variable airflow limitation within the past 10-years to confirm asthma diagnosis
- •Meets diagnostic criteria for moderate, or severe asthma
- •Reports breathlessness impacting daily life physical activities (modified Medical Research Council [mMRC] dyspnoea score ≥1) within the past 1-week
- •Owns a smart device with internet access, which they are willing and able to use for the study duration
排除标准
- •High dependence on medical care
- •Significant life-limiting comorbidity (<12 months life expectancy)
- •Cognitive impairment, poor English language skills or significant untreated hearing impairment that prevents completion of data collection forms or understanding of verbal instructions
- •Current participation in any other clinical trial, or participation in another clinical trial within the 4-weeks preceding study entry.
研究组 & 干预措施
Digital self-management platform and enhanced usual care
干预措施: Multicomponent digital self-management platform (Behavioral)
Digital self-management platform and enhanced usual care
干预措施: Enhanced usual care (Other)
Enhanced usual care
干预措施: Enhanced usual care (Other)
结局指标
主要结局
Asthma Quality of Life Questionnaire (AQLQ)
时间窗: 6-months
Items are rated on a 7-point Likert scale, with higher scores indicating better quality of life. A mean score across all items equally weighted is reported. The minimal clinically important difference has been estimated to be 0.5 units.
次要结局
- Asthma Control Questionnaire-5 (ACQ-5)(6-months & 12-months)
- Shortness of Breathlessness with Daily Activities (SOBDA)(6-months & 12-month)
- Multidimensional Dyspnea Profile (MDP)(6-months & 12-month)
- Dyspnoea-12 (D-12)(6-months & 12-months)
- Physical activity(6-months & 12-months)
- Theoretical framework of acceptability (TFA) questionnaire(6-months & 12-months)
- EuroQol 5-Dimension 5-Level ( EQ-5D-5L)(12-months)
- Acceptability of Intervention Measure (AIM)(6-months & 12-months)
- Intervention Appropriateness Measure (IAM)(6-months & 12-months)
- Feasibility of Intervention Measure (FIM)(6-months & 12-months)