Prevalence of ADHD and Health Outcomes in Adult Outpatients With Psychiatric Disorders: a Multi-country, Two-part, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 14
- 主要终点
- Part I: Percentage of Participants With Positive or Negative ADHD Diagnosis
研究概览
简要总结
The main aim of the study is to find out how frequently adults with at least one psychiatric condition have ADHD (but have not been diagnosed with ADHD before) and to describe the quality of life of these adults who have been diagnosed with ADHD. To find out how often ADHD is not diagnosed in these adults could provide awareness about this condition and could help to improve preventing underdiagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Part I: Percentage of Participants With Positive or Negative ADHD Diagnosis
时间窗: At baseline
Percentage of participants with positive or negative ADHD diagnosis will be reported.
Part II: Change From Baseline in AAQoL by ADHD-Specific Clinical Management
时间窗: Baseline, 3-month, and 9-month follow up
AAQoL (32) is an instrument designed to evaluate the quality of life in ADHD adult participants It has 29 items organized in four domains: Life Productivity (11 items); Psychological Health (6 items), Life Outlook (7 items) and Relationships (5 items). Each item is rated with a five-point Likert scale ranging from 1= Not at all/Never to 5=Extremely/Very Often. Total and domain-specific scores are computed by reversing scores for all items, except those in the Life Outlook domain; transforming all item scores to a 0 to100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and summing the item scores and dividing by them by item count. Total score ranges from 0 to 100 with higher score representing better quality of life. Change from baseline in AAQoL by ADHD-Specific Clinical Management will be reported.
Part II: Change From Baseline in Quality of Life- questionnaire (AAQoL) by Overall Psychological/Psychiatric Clinical Management
时间窗: Baseline, 3 Month and 9-Month of follow-up
AAQoL (32) is an instrument designed to evaluate the quality of life in ADHD adult participants It has 29 items organized in four domains: Life Productivity (11 items); Psychological Health (6 items), Life Outlook (7 items) and Relationships (5 items). Each item is rated with a five-point Likert scale ranging from 1= Not at all/Never to 5=Extremely/Very Often. Total and domain-specific scores are computed by reversing scores for all items, except those in the Life Outlook domain; transforming all item scores to a 0 to100 point scale (1=0; 2=25; 3=50; 4=75; 5=100); and summing the item scores and dividing by them by item count. Total score ranges from 0 to 100 with higher score representing better quality of life. Change from baseline in AAQoL by overall psychological/psychiatric clinical management will be reported.
次要结局
- Part II: Number of Modalities for ADHD-specific Psychiatric/Psychological Clinical Management(Baseline, 3 Month and 9-Month of follow-up)
- Part II: Duration of Treatment for ADHD-Specific Psychiatric/Psychological Clinical Management(Baseline, 3 Month and 9-Month of follow-up)
- Part II: Change From Baseline in Clinical Global Impressions Scale- Improvement (CGI-I) Score(Baseline, 3 Month and 9-Month of follow-up)
- Part II: Functionality Level and Quality of Life by ADHD-Specific Clinical Management(Baseline, 3-month, and 9-month follow up)
- Part I: Percentage of Participants With Confirmed Diagnosis of ADHD Based on Adult ADHD Self-Reporting Scale (ASRS)(At baseline)
- Part I: Percentage of Participants With Confirmed Diagnosis of ADHD Based on Diagnostic Interview for Adult ADHD (DIVA 5.0)(At baseline)
- Part II: Number of Modalities for Non-ADHD Psychiatric/Psychological clinical management(Baseline, 3 Month and 9-Month of follow-up)
- Part I: Percentage of Participants With Confirmed Diagnosis of ADHD Based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5)(At baseline)
- Part II: Type of Treatment Given to Participants with ADHD for Non-ADHD Psychiatric/Psychological Clinical Management(Baseline, 3 Month and 9-Month of follow-up)
- Part II: Duration of Treatment for Non-ADHD Psychiatric/Psychological Clinical Management(Baseline, 3 Month and 9-Month of follow-up)
- Part II: Type of Treatment Given to Participants with ADHD for ADHD-Specific Overall Psychiatric/Psychological Clinical Management(Baseline, 3 Month and 9-Month of follow-up)
- Change From Baseline in Health Resource Utilization (HRU)(Baseline, 3 Month and 9-Month of follow-up)
- Part II: Change From Baseline in Functional Assessment Short Test (FAST) Score(Baseline, 3 Month and 9-Month of follow-up)
- Part II: Change From Baseline in Clinical Global Impressions Scale- Severity of Illness (CGI-S)(Baseline, 3 Month and 9-Month of follow-up)