Digitaalisen psykoterapeuttisen sovelluksen käyttö oireiden vähentämiseen ihotautipotilailla
Digitaalisen psykologisen työkalun kehittäminen ja testaus ihotautipotilaiden oiretaakan parantamiseksi
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Ellie Choi, MBBS
- Puhelinnumero: 65 6908 2222
- Sähköposti: dermresearchec@nuhs.edu.sg
Opiskelupaikat
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Singapore, Singapore, 609783
- Rekrytointi
- National University Hospital
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Ottaa yhteyttä:
- Ellie Choi
- Puhelinnumero: 67795555
- Sähköposti: dermresearchec@nuhs.edu.sg
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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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Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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.
Muut nimet:
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Active Comparator: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Skin-specific quality of life impairment
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Physician assessed body surface area affected
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Type D personality
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Tutkijat
- Päätutkija: Ellie Choi, MBBS, National University Hospital, Singapore
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2022/00751
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD shared includes de-identified demographics, disease outcomes and measures.
IPD-jaon aikakehys
IPD and supporting information will be available from the time of publication and for four years thereafter.
IPD-jaon käyttöoikeuskriteerit
IPD and supporting information will be available from the study team on a case-by-case basis upon request.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
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