Использование цифрового психотерапевтического приложения для снижения симптоматической нагрузки у дерматологических пациентов
Разработка и тестирование цифрового психологического инструмента для снижения симптоматической нагрузки у дерматологических пациентов
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Ellie Choi, MBBS
- Номер телефона: 65 6908 2222
- Электронная почта: dermresearchec@nuhs.edu.sg
Места учебы
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Singapore, Сингапур, 609783
- Рекрутинг
- National University Hospital
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Контакт:
- Ellie Choi
- Номер телефона: 67795555
- Электронная почта: dermresearchec@nuhs.edu.sg
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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:
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Patients with active psychiatric symptoms (e.g. active suicidal ideation, psychosis, delusions)
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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
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Patients with unstable dermatological condition, characterized by
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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
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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.
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Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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. |
Mobile app comprising various psychobehavioural tools to educate, enhance self-efficacy and coping and promote wellness in dermatological patients.
Другие имена:
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Активный компаратор: 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. |
Mobile application by the Health Promotion Board (HPB) Singapore which aims to encourage users to adopt a healthier lifestyle. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Skin-specific quality of life impairment
Временное ограничение: baseline, week 8
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Dermatology Life Quality Index (DLQI). Minimum Score: 0 (no impact on quality of life). Maximum Score: 30 (extremely large impact on quality of life). |
baseline, week 8
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Physician assessed body surface area affected
Временное ограничение: baseline, week 8 and 16
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Range from 0% (no affected area) to 100% (complete involvement) |
baseline, week 8 and 16
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Investigator/physician global assessment
Временное ограничение: baseline, week 8, week 16
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0 to 5 point numerical rating scale, with a higher value signalling greater severity |
baseline, week 8, week 16
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Eczema severity
Временное ограничение: baseline, week 8, week 16
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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. |
baseline, week 8, week 16
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Psoriasis Severity
Временное ограничение: baseline, week 8, week 16
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Psoriasis Area and Severity Index. Severity assessment for patients with psoriasis. Score ranges from 0-72 with higher scoring indicating more severe disease. |
baseline, week 8, week 16
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Chronic urticaria severity
Временное ограничение: baseline, week 8, week 16
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Urticaria Activity Score-7 (UAS7). Assess severity for patients with chronic urticaria. Score ranges from 0-6. |
baseline, week 8, week 16
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Composite measure of scratching
Временное ограничение: baseline, week 8, week 16
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Global severity and body surface area affected of various scratching measures e.g excoriation, lichenification, prurigo |
baseline, week 8, week 16
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Itch
Временное ограничение: baseline, weeks 4, 8, 12, 16, 24, 32
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0-10 numerical rating scale, with higher scores signalling greater itch |
baseline, weeks 4, 8, 12, 16, 24, 32
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Skin pain
Временное ограничение: baseline, week 4, week 8, week 12, week 16, week 24, week 32
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0-10 numerical rating scale, greater scores signalling greater pain |
baseline, week 4, week 8, week 12, week 16, week 24, week 32
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Sleep disturbance
Временное ограничение: baseline, weeks 4, 8, 12, 16, 24, 32
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0-10 numerical rating scale, with higher scores signalling greater sleep disturbance |
baseline, weeks 4, 8, 12, 16, 24, 32
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Depression
Временное ограничение: baseline, week 8, week 16, week 24 and 32
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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. |
baseline, week 8, week 16, week 24 and 32
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Anxiety
Временное ограничение: baseline, weeks 8, 16, 24 and 32
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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. |
baseline, weeks 8, 16, 24 and 32
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Number of patients requiring treatment escalation
Временное ограничение: baseline, week 8, 16 and 32
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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 |
baseline, week 8, 16 and 32
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Work productivity and activity impairment
Временное ограничение: baseline and week 16
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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. |
baseline and week 16
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EQ-5D-5L
Временное ограничение: baseline, week 32
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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 |
baseline, week 32
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Skin-specific quality of life impairment
Временное ограничение: week 4, week 12, week 16, week 24, week 32
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Dermatology Life Quality Index (DLQI). Minimum Score: 0 (no impact on quality of life). Maximum Score: 30 (large impact on quality of life). |
week 4, week 12, week 16, week 24, week 32
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Implementability - App Engagement Scale
Временное ограничение: week 32
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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. |
week 32
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Implementability - Frequency of app usage
Временное ограничение: week 8, week 32
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Frequency of using the mobile app, ranging from never to everyday |
week 8, week 32
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Implementability - Duration of app usage
Временное ограничение: week 8, week 32
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Average duration of app use each time, ranging from less than 2 minutes to more than 40 minutes. |
week 8, week 32
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Implementability - Willingness to pay
Временное ограничение: week 32
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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' |
week 32
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Implementability - Barriers and facilitators of use
Временное ограничение: Post 32 weeks after participant's study completion
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Qualitative interviews with thematic analysis to determine barriers and facilitators of use and long term sustainability |
Post 32 weeks after participant's study completion
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Implementability - Percentage completed learning paths/ modules
Временное ограничение: baseline to week 32
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Passively collected in mobile app's logs. |
baseline to week 32
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Implementability - Appropriate responses and engagement to tracking exercises and open ended questions in the app
Временное ограничение: Baseline to week 32
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Passive collected in mobile app's logs. |
Baseline to week 32
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Implementability - Collective server statistics
Временное ограничение: baseline to week 32
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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. |
baseline to week 32
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Implementability - Likely frequency of app use after study
Временное ограничение: week 32
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Likely frequency of app usage after the study, ranging from never to everyday. |
week 32
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Implementability - Likes and dislikes
Временное ограничение: week 32
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Two free-text questions collecting qualitative feedback on participants' likes and dislikes about the app, respectively. |
week 32
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Implementability - Suggestions and feedback
Временное ограничение: week 32
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Free-text question collecting suggestions and feedback to improve the mobile app. |
week 32
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Physician assessed global disease severity
Временное ограничение: baseline, week 8, week 16
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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. |
baseline, week 8, week 16
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Physician assessed clinical global change
Временное ограничение: week 8, week 16
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Clinician-assessed change in patient's overall status since the start of the study. Ranges from very much improved to very much worse. |
week 8, week 16
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Patient's disease severity grading
Временное ограничение: baseline, week 4, week 8, week 12, week 16, week 24, week 32
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A question assessing patient's overall global assessment of disease severity, ranging from 0 to 10, with higher scores indicating higher severity. |
baseline, week 4, week 8, week 12, week 16, week 24, week 32
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Patient Global Impression of Severity
Временное ограничение: baseline, week 4, week 8, week 12, week 16, week 24, week 32
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Patient reported global severity rating, ranging from none to very severe. |
baseline, week 4, week 8, week 12, week 16, week 24, week 32
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Patient Global Impression of Change
Временное ограничение: week 4, week 8, week 12, week 16, week 24, week 32
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Patient reported change in overall status from the start of the study, ranging form very much improved to very much worse. |
week 4, week 8, week 12, week 16, week 24, week 32
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Type D personality
Временное ограничение: baseline and week 16
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DS-14, measure of type D personality. The negative affect and social inhibition scales are scored from 0-28 with a higher score representing greater trait. A cutoff of 10 on each scale is used to classify type D personality. |
baseline and week 16
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Itch characteristic
Временное ограничение: 0, week 8
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5D Pruritus scale ranges from 5 to 25, where 5 indicates no pruritus and 25 indicates the most severe pruritus. |
0, week 8
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Scratching behavior
Временное ограничение: baseline, week 8, week 16, week 24, week 32
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PROMIS Itch Questionnaire Scratching Behaviour 5a. Score ranges fro 0-25 with higher score indicating greater scratching behaviours. Scores are standardized with 50 representing the mean. |
baseline, week 8, week 16, week 24, week 32
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Acceptance of health condition
Временное ограничение: baseline, week 8, week 16, 32
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Acceptance of Chronic Health Conditions Scale. Scores range from 8 to 40. Higher scores indicate greater acceptance of the chronic health condition. |
baseline, week 8, week 16, 32
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Revised illness perception questionnaire
Временное ограничение: baseline, week 8, week 16, 32
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Assessment of how individuals perceive their illness including cognitive and emotional representations of illness across several dimensions. Each dimension is scored separately and expressed as a percentage (0-100%), with higher scores indicating more strongly held beliefs. |
baseline, week 8, week 16, 32
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Resilience
Временное ограничение: baseline, week 8, week 16, 24, 32
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Brief Resilience Scale. The total score on the Brief Resilience Scale (BRS) ranges from 6 to 30. This scale measures an individual's ability to bounce back from stress and adversity. A higher score indicates greater resilience, while a lower score suggests lower resilience. |
baseline, week 8, week 16, 24, 32
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Self Efficacy in managing emotions
Временное ограничение: baseline, week 8, 32
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PROMIS self-efficacy in managing emotions 4a. Score ranges from 4 to 20 which are standardized and expressed as a percentage from 0-100%, with higher score indicating greater self efficacy. |
baseline, week 8, 32
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Mindfulness
Временное ограничение: baseline, week 8, 32
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2 questions from the Cognitive and Affective Mindfulness Scale- Revised (CAMS-R). Score ranges from 0-6 with higher score indicating more mindfulness. |
baseline, week 8, 32
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Self stigmatization
Временное ограничение: baseline, week 8, week 16, 32
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Weight bias internalization scale, modified for skin conditions. The score ranges from 11 to 77. Higher scores indicate greater internalization of bias/negative perception towards self. |
baseline, week 8, week 16, 32
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Social Comparison
Временное ограничение: baseline, week 8, week 16, 32
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The DermSC scale comprises 3 questions, testing the general tendency for social comparison, downward negative comparison and upward negative comparison. The scores of each question (1-5 points) are tabulated (range 3-15) with a higher score indicating a greater degree of social comparison. |
baseline, week 8, week 16, 32
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Well being
Временное ограничение: baseline, week 8, week 16, 24, 32
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World Health Organisation-Five Well-Being Index (WHO-5) ranges from 0-25 which is converted to an index score 0-100 with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. |
baseline, week 8, week 16, 24, 32
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Adherence
Временное ограничение: baseline, week 8, week 16, 32
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Self-reported treatment adherence, represented as a percentage from 0-100% where higher scores indicate greater adherence. |
baseline, week 8, week 16, 32
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Self-efficacy for managing social interactions
Временное ограничение: baseline, week 8, week 32
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2 questions from PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Social Interactions. It assesses confidence in social activities and help seeking, ranging from I am not at confident to I am very confident. |
baseline, week 8, week 32
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Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Ellie Choi, MBBS, National University Hospital, Singapore
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания иммунной системы
- Гиперчувствительность, немедленная
- Гиперчувствительность
- Кожные заболевания, папулосквамозный
- Кожные заболевания
- Кожные заболевания, сосудистые
- Кожные заболевания, экзематозные
- Дерматит
- Поведение
- Заболевания кожи и соединительной ткани
- Личное удовлетворение
- Псориаз
- Экзема
- Крапивница
- Психологическое благополучие
Другие идентификационные номера исследования
- 2022/00751
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
IPD shared includes de-identified demographics, disease outcomes and measures.
Сроки обмена IPD
IPD and supporting information will be available from the time of publication and for four years thereafter.
Критерии совместного доступа к IPD
IPD and supporting information will be available from the study team on a case-by-case basis upon request.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- МКФ
- АНАЛИТИЧЕСКИЙ_КОД
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .