Development and Testing of a Digital Psychological Tool to Improve Symptom Burden in Dermatology Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 690
- 试验地点
- 1
- 主要终点
- Skin-specific quality of life impairment
研究概览
简要总结
Skin diseases, despite low mortality, significantly impair quality of life. This randomised controlled trial evaluates the efficacy of a digital toolkit comprising psychotherapeutic strategies in reducing QoL burden in patients with chronic inflammatory skin conditions. This toolkit is hosted on a mobile application and will be used by study participants randomised to the intervention arm over the 32 week study period.
详细描述
Chronic inflammatory skin diseases, despite low mortality, significantly impair quality of life. Up to 80% of dermatological patients experience severe itch and poor sleep, and related such mental health challenges as anxiety and depression. The relationship between skin diseases and mental health highlights the challenges that doctors face in treating these conditions. Existing psychotherapeutics such as Mindfulness training, Cognitive Behavioural Therapy, and Acceptance and Commitment Therapy are widely used and effective in the treatment of mental health illness. However, there is limited evidence on the application of such interventions in dermatology and most mental health apps lack robust clinical evaluation. We report the design of a randomised controlled trial to evaluate the efficacy and implementation of a mobile app containing dermatology-specified psychotherapeutic strategies in reducing QoL burden.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with psoriasis, eczema or chronic urticaria diagnosed by a dermatologist
- •Aged 16 or older
- •Peak pruritus intensity of 4 or more on a 11-point numerical rating scale (0-10, with 10 representing worst itch)
- •Able to engage with a mobile application in the English language
排除标准
- •Patients with active psychiatric symptoms (e.g. active suicidal ideation, psychosis, delusions)
- •Patients with unstable psychiatric condition, characterized by
- •o Hospital inpatient admission for a psychiatric condition or initiation of a psychotropic medication in the prior 3 months
- •Patients with unstable dermatological condition, characterized by
- •Recent flare of the skin condition within the last 2 weeks, including diagnosis of a flare by a doctor, use of systemic steroids, oral antibiotics, wet wrap rescue therapy, oral antivirals, or increase in frequency of phototherapy or dose of systemic medications for the dermatological condition within the last 2 weeks OR
- •Any of the following within 3 months
- •inpatient admission for a dermatological condition
- •Initiation of phototherapy
- •Initiation of systemic therapy (conventional immunosuppressive agent, biologics, JAK inhibitors) within the last 3 months.
研究组 & 干预措施
Intervention Arm
This fully automated and self-administered intervention will be delivered via a Health Insurance Portability and Accountability Act (HIPAA) compliant mobile app developed in collaboration with Intellect Inc., a Singapore-based mobile health company with broad reach and prior research collaborations in the Asia Pacific region. A detailed discussion focusing on the engineering of the application including the user interface, data acquisition and curation technology, security and privacy assurance is available from the authors.
干预措施: Digital psychotherapeutic intervention (Behavioral)
Control
Participants in the active control group will download use the Healthy365 app, a mobile health application managed by the Singapore government's Health Promotion Board. The Healthy365 app offers a variety of useful general health-related content which are not specific to skin disease. These include personalized health tracking, participation in fitness challenges, access to nutritional guidance, and personalized lifestyle recommendations.
干预措施: Healthy365 (Behavioral)
结局指标
主要结局
Skin-specific quality of life impairment
时间窗: baseline, week 8
Dermatology Life Quality Index (DLQI). Minimum Score: 0 (no impact on quality of life). Maximum Score: 30 (extremely large impact on quality of life).
次要结局
- Physician assessed body surface area affected(baseline, week 8 and 16)
- Investigator/physician global assessment(baseline, week 8, week 16)
- Eczema severity(baseline, week 8, week 16)
- Psoriasis Severity(baseline, week 8, week 16)
- Chronic urticaria severity(baseline, week 8, week 16)
- Composite measure of scratching(baseline, week 8, week 16)
- Itch(baseline, weeks 4, 8, 12, 16, 24, 32)
- Skin pain(baseline, week 4, week 8, week 12, week 16, week 24, week 32)
- Sleep disturbance(baseline, weeks 4, 8, 12, 16, 24, 32)
- Depression(baseline, week 8, week 16, week 24 and 32)
- Anxiety(baseline, weeks 8, 16, 24 and 32)
- Work productivity and activity impairment(baseline and week 16)
- EQ-5D-5L(baseline, week 32)
- Implementability - Likes and dislikes(week 32)
- Skin-specific quality of life impairment(week 4, week 12, week 16, week 24, week 32)
- Implementability - App Engagement Scale(week 32)
- Implementability - Frequency of app usage(week 8, week 32)
- Implementability - Duration of app usage(week 8, week 32)
- Implementability - Willingness to pay(week 32)
- Implementability - Suggestions and feedback(week 32)
- Implementability - Barriers and facilitators of use(Post 32 weeks after participant's study completion)
- Implementability - Percentage completed learning paths/ modules(baseline to week 32)
- Implementability - Appropriate responses and engagement to tracking exercises and open ended questions in the app(Baseline to week 32)
- Implementability - Collective server statistics(baseline to week 32)
- Implementability - Likely frequency of app use after study(week 32)
- Physician assessed global disease severity(baseline, week 8, week 16)
- Physician assessed clinical global change(week 8, week 16)
- Patient's disease severity grading(baseline, week 4, week 8, week 12, week 16, week 24, week 32)
- Patient Global Impression of Severity(baseline, week 4, week 8, week 12, week 16, week 24, week 32)
- Patient Global Impression of Change(week 4, week 8, week 12, week 16, week 24, week 32)
- Number of patients requiring treatment escalation(baseline, week 8, 16 and 32)