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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
690
Mobile app comprising various psychobehavioural tools to educate, enhance self-efficacy and coping and promote wellness in dermatological patients.
Mobile application by the Health Promotion Board (HPB) Singapore which aims to encourage users to adopt a healthier lifestyle.
Skin-specific quality of life impairment
Dermatology Life Quality Index (DLQI). Minimum Score: 0 (no impact on quality of life). Maximum Score: 30 (extremely large impact on quality of life).
Time frame: baseline, week 8
Physician assessed body surface area affected
Range from 0% (no affected area) to 100% (complete involvement)
Time frame: baseline, week 8 and 16
Investigator/physician global assessment
0 to 5 point numerical rating scale, with a higher value signalling greater severity
Time frame: baseline, week 8, week 16
Eczema severity
Eczema Area and Severity Index. Scoring system used to assess the severity of atopic dermatitis. Score ranges from 0 to 72 with higher score indicating worse severity.
Time frame: baseline, week 8, week 16
Psoriasis Severity
Psoriasis Area and Severity Index. Severity assessment for patients with psoriasis. Score ranges from 0-72 with higher scoring indicating more severe disease.
Time frame: baseline, week 8, week 16
Chronic urticaria severity
Urticaria Activity Score-7 (UAS7). Assess severity for patients with chronic urticaria. Score ranges from 0-6.
Time frame: baseline, week 8, week 16
Composite measure of scratching
Global severity and body surface area affected of various scratching measures e.g excoriation, lichenification, prurigo
Time frame: baseline, week 8, week 16
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Itch
0-10 numerical rating scale, with higher scores signalling greater itch
Time frame: baseline, weeks 4, 8, 12, 16, 24, 32
Skin pain
0-10 numerical rating scale, greater scores signalling greater pain
Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32
Sleep disturbance
0-10 numerical rating scale, with higher scores signalling greater sleep disturbance
Time frame: baseline, weeks 4, 8, 12, 16, 24, 32
Depression
PROMIS (Patient-Reported Outcomes Measurement Information System) Depression 8b. The raw score range for the PROMIS Depression 8b ranges from 8 to 40 with higher scores indicating greater depressive symptoms. The raw score is then converted to a T-score using a standardized conversion table. The T scores have a mean of 50 and standard deviation (SD) of 10, a higher value signals greater depressive symptoms.
Time frame: baseline, week 8, week 16, week 24 and 32
Anxiety
PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety 7a. The raw score range from 7-35 with higher scores indicating greater anxiety symptoms. The raw score is then converted to a T-score using a standardized conversion table. The T scores have a mean of 50 and standard deviation (SD) of 10, a higher value signals greater depressive symptoms.
Time frame: baseline, weeks 8, 16, 24 and 32
Number of patients requiring treatment escalation
Number of patients requiring treatment escalation, defined as any of the following \- Initiation or escalation of systemic treatments; inclusive of conventional immunosuppressants, biologics, systemic steroids
Time frame: baseline, week 8, 16 and 32
Work productivity and activity impairment
Modified Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: SHP, Version 2 (WPAI+CIQ:SHP, V 2). Assesses the impact of health problems on a person's ability to work and perform regular daily activities. Scores are multiplied by 100 to express in percentages with higher scorings indicating greater impairment and less productivity. Two additional questions assessing time spent on problems associated with skin condition and employment status, respectively.
Time frame: baseline and week 16
EQ-5D-5L
EuroQol Group EQ-5D is a measure of health state/health utility. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state
Time frame: baseline, week 32
Skin-specific quality of life impairment
Dermatology Life Quality Index (DLQI). Minimum Score: 0 (no impact on quality of life). Maximum Score: 30 (large impact on quality of life).
Time frame: week 4, week 12, week 16, week 24, week 32
Implementability - App Engagement Scale
App Engagement Scale. 7 questions graded on a likert scale. Items are summed, with scores ranging from 7 to 35, with a higher score indicating greater engagement.
Time frame: week 32
Implementability - Frequency of app usage
Frequency of using the mobile app, ranging from never to everyday
Time frame: week 8, week 32
Implementability - Duration of app usage
Average duration of app use each time, ranging from less than 2 minutes to more than 40 minutes.
Time frame: week 8, week 32
Implementability - Willingness to pay
Single bounded willingness to pay, 'How much would you maximally be willing to pay/month to continue using this mobile app?' with responses ranging from 'I would not use it even if free' to 'I would pay $41 or more /month'
Time frame: week 32
Implementability - Barriers and facilitators of use
Qualitative interviews with thematic analysis to determine barriers and facilitators of use and long term sustainability
Time frame: Post 32 weeks after participant's study completion
Implementability - Percentage completed learning paths/ modules
Passively collected in mobile app's logs.
Time frame: baseline to week 32
Implementability - Appropriate responses and engagement to tracking exercises and open ended questions in the app
Passive collected in mobile app's logs.
Time frame: Baseline to week 32
Implementability - Collective server statistics
Mobile app's collective server access statistics is tracked to determine which pages have the lowest and highest traffic and to analyse 'helpfulness' ratings of each module.
Time frame: baseline to week 32
Implementability - Likely frequency of app use after study
Likely frequency of app usage after the study, ranging from never to everyday.
Time frame: week 32
Implementability - Likes and dislikes
Two free-text questions collecting qualitative feedback on participants' likes and dislikes about the app, respectively.
Time frame: week 32
Implementability - Suggestions and feedback
Free-text question collecting suggestions and feedback to improve the mobile app.
Time frame: week 32
Physician assessed global disease severity
Assesses patient's overall, emotional, functional, and physical severity, and physician's perception of how the patient graded overall severity. Range from 0 to 10, with higher value signalling greater severity.
Time frame: baseline, week 8, week 16
Physician assessed clinical global change
Clinician-assessed change in patient's overall status since the start of the study. Ranges from very much improved to very much worse.
Time frame: week 8, week 16
Patient's disease severity grading
A question assessing patient's overall global assessment of disease severity, ranging from 0 to 10, with higher scores indicating higher severity.
Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32
Patient Global Impression of Severity
Patient reported global severity rating, ranging from none to very severe.
Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32
Patient Global Impression of Change
Patient reported change in overall status from the start of the study, ranging form very much improved to very much worse.
Time frame: week 4, week 8, week 12, week 16, week 24, week 32