Acne vulgaris Skin and Connective Tissue Diseases
Conditions
Interventions
In both the feasibility and full scale trials, recruited participants will be randomised using the LifeGuide software hosting the digital intervention into one of two groups:
Intervention arm (immedi
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Age
13 Years to 25 Years
Inclusion criteria
Inclusion criteria: 1. Aged 13-25 years with self-defined acne with current active lesions (i.e. mild or worse on self-assessment scale) 2. Have internet access For primary care recruitment GPs will invite potential participants via database searches that will identify patients aged 13 to 25 years who either: 1. Have been prescribed a topical treatment for acne or co-cyprindiol in the previous 12 months or 2. Have a diagnostic code for acne on their electronic record over the previous 12 months either with or without having been prescribed an oral tetracycline or erythromycin in that period.
Exclusion criteria
Exclusion criteria: 1. Their acne is currently clear or almost clear, i.e. if they answer ‘no’ to the following question asked online at baseline screening: “Do you have spots or acne on your face at the moment? This could include whiteheads or more red spots or bumps.” 2. They are unable to give informed consent or their parent does not provide consent (for participants aged 13-15 recruited via community or social media advertising) 3. They are unable to read and write English as the intervention content and outcome measures are in English 4. They are currently taking oral isotretinoin or have taken it within the previous 3 months, as advice about topical acne treatments may be inappropriate in this case 5. They took part in interviews as part of Acne Care Online intervention development. (Qualitative interviewees who did not view intervention materials will NOT be excluded) 6. Only one person per household will be able to take part in the study. If someone from that household has already joined the study then they will be excluded from the study 7. If the feasibility trial remains separate to the full scale trial, participants in the feasibility trial will be excluded from the full-scale trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acne severity measured using the Acne-QoL symptoms subscale at 12 weeks, compared with baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acne severity evaluated over 12 months using Acne-QoL symptom subscale, using repeated measures analysis over 12 weeks, 24 weeks, 36 weeks and 52 weeks, controlled for baseline 2. Acne-QoL other subscales (self-perception, role-emotional and role-social) and total score evaluated over 12 months using Acne-QoL symptom subscale using repeated measures analysis over 12 weeks, 24 weeks, 36 weeks and 52 weeks, controlled for baseline 3. Use of topical treatment for acne at baseline, 12 weeks, 24 weeks, 36 weeks and 52 weeks (self-report and treatment adherence) 4. Use of acne-related antibiotics and other oral acne treatment use at baseline, 12 weeks, 24 weeks, 36 weeks and 52 weeks, including frequency of use (self-report) 5. Past use of topical and oral treatments for acne 6. Problematic Experiences of Therapy Scale (PETS) will be asked prior to adherence questions at baseline,12 weeks and 52 weeks. 7. Patient Enablement Instrument (PEI) at baseline, 12 weeks and 52 weeks 8. Brief Illness Perceptions Questionnaire (BIPQ) at baseline, 12 weeks and 52 weeks 9. Patient Health Questionnaire (PHQ–4) for Anxiety and Depression at baseline, 12 weeks and 52 weeks 10. EQ-5D-5L at baseline, 12 weeks, 24 weeks, 36 weeks and 52 weeks 11. Short Warwick Edinburgh Mental Well-being Scale (SWEMWBS) at baseline, 12 weeks, 24 weeks, 36 weeks and 52 weeks 12. Resource use will be measured at baseline, 12 weeks, 24 weeks, 36 weeks and 52 weeks (self-report) 13. Prior belief in effectiveness of online interventions will be asked at baseline and use and type of online resources previously used for acne will be asked at baseline, 12 weeks and 52 weeks 14. Demographics 15. Age of onset and duration of acne Part of the objective of the feasibility trial is to assess questionnaire burden and if this is not acceptable to participants we will consider not including the Brief IPQ and SWEMWBS in the full scale trial | — |
Countries
England, United Kingdom
Contacts
Public ContactJulie Hooper
Outcome results
None listed