Coping With Asthma Throughout Life Management: CALM Program for African American Adult Patients With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 50
- 主要终点
- Feasibility of Intervention Measure (FIM)
研究概览
简要总结
The purpose of this study is to determine if the Coping with Asthma through Life Management (CALM) intervention, designed to help Black adult with asthma cope with stress, is feasible and acceptable.
详细描述
Asthma medication nonadherence is a major contributor to asthma morbidity and mortality in Black adults. Black adults with asthma reported that increased psychosocial stress (e.g., perceived discrimination, job stress, caregiver burden), health-related stress (e.g., concern about asthma control), and economic stress (e.g., economic strain) were barriers to asthma medication adherence and control. The study's hypothesis is that CALM, targeting multiple stressors specifically faced by Black adults with asthma, will be feasibly implemented in a health system, will be acceptable to program participants, and will be a potentially effective intervention to improve asthma medication adherence and asthma control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •At least the age of 18
- •Self identify as Black/African-American
- •Self-report current asthma diagnosis
- •Asthma must be persistent (Prescribed an inhaled corticosteroid (alone or in combination)
- •Asthma must be uncontrolled (≥1 exacerbation in the past years OR Asthma Control Questionnaire > 0.75)
- •Have moderate-high stress (Perceived Stress Scale ≥ 14)
- •Presented at any Primary Care clinic in the past 3 years.
排除标准
- •Unable or unwilling to give consent
- •Diagnosis of a psychotic disorder
- •Positive responses to questions regarding suicidality
研究组 & 干预措施
Randomized
Group will receive intervention method
干预措施: Coping with asthma through life management program (Behavioral)
Waitlist Control Group
Participants will receive no intervention (control) during the trial. However, after the study is completed, they will have the option to receive intervention.
干预措施: Waitlist Control (CALM) (Behavioral)
结局指标
主要结局
Feasibility of Intervention Measure (FIM)
时间窗: 12 weeks
The FIM has four items and the total score ranges from 4 to 20, where a higher score indicates greater feasibility.
Acceptability of Intervention Measure (AIM)
时间窗: 12 Weeks
The AIM has four items and the total score ranges from 4 to 20, where a higher score indicates greater acceptability.
Intervention Appropriateness Measure (IAM)
时间窗: 12 Weeks
The IAM has four items and the total score ranges from 4 to 20, where a higher score indicates greater appropriateness.
Feasibility of Intervention Measure (FIM)
时间窗: 12 weeks
The FIM has four items and the total score ranges from 4 to 20, where a higher score indicates greater feasibility.
Acceptability of Intervention Measure (AIM)
时间窗: 12 Weeks
The AIM has four items and the total score ranges from 4 to 20, where a higher score indicates greater acceptability.
次要结局
- Asthma Quality of Life Questionnaire, Marks (AQLQ-M)(2 weeks)
- Number of participants with an asthma exacerbation event(12 weeks)
- Perceived Stress Scale (PSS-10)(1 month)
- Asthma Control Questionnaire (ACQ-6)(1 week)
- Number of participants with an asthma exacerbation event(12 weeks)