Development and Testing of a Digital Psychological Tool to Improve Symptom Burden in Dermatology Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Eczema
- Sponsor
- National University Hospital, Singapore
- Enrollment
- 690
- Primary Endpoint
- Skin-specific quality of life impairment
- Status
- Not Yet Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Skin-specific quality of life impairment
Time Frame: 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).
Secondary Outcomes
- 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)
- Number of patients requiring treatment escalation(baseline, week 8, 16 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)