Acne Care Online: protocol for a randomised trial of a digital behaviour change intervention to improve acne-related quality of life amongst 13-25 year olds
<ns5:p>Background Acne is common with substantial impact on quality of life and health care costs. Antibiotics are frequently prescribed, leading to antibiotic resistance. Guidelines recommend topical treatments as first-line therapy, but they are under-used due to low awareness, avoidable side effects or delayed onset of action. AcneCareOnline, an online behavioural intervention, was developed to support self-management for young people with acne. Methods Multi-centre 1:1 randomized controlled trial with economic evaluation and process evaluation of AcneCareOnline. The trial will recruit people aged 13–25 years with self-defined acne and active lesions (on self-assessment scale). Participants will be recruited through English general practices, community pharmacies, schools/colleges, community and social media advertising. Intervention group receive access to AcneCareOnline. Control group are signposted to NHS advice and given access to the intervention after follow-up. Both groups have access to usual care. Follow-up is for 52 weeks. Target sample size is 908 participants. Outcomes Primary outcome is acne severity at 12 weeks, measured using Acne-QoL symptoms subscale. Secondary outcomes include; acne severity evaluated over 12 months (Acne-QoL symptoms subscale), other Acne-QoL subscales; self-reported treatment use, Patient Enablement Instrument, Brief Illness Perceptions Questionnaire, Patient Health Questionnaire, EQ-5D-5L, Short Warwick Edinburgh Mental Well-being Scale, and resource use. Process evaluation includes qualitative interviews to explore trial participants’ engagement with the intervention and quantitative examination of potential moderator effects on intervention engagement. Economic evaluation includes cost utility analyses to estimate the cost-effectiveness of the online intervention compared to usual care alone from NHS and participant perspectives.</ns5:p>
Authors
- Kim S Thomas (ORCID: https://orcid.org/0000-0001-7785-7465)
- Matthew J Ridd (ORCID: https://orcid.org/0000-0002-7954-8823)
- Miriam Santer (ORCID: https://orcid.org/0000-0001-7264-5260)
- Mary Steele (ORCID: https://orcid.org/0000-0003-2595-3855)
- I. Muller
- Tracey Sach (ORCID: https://orcid.org/0000-0002-8098-9220)
- Rosie Essery (ORCID: https://orcid.org/0000-0002-2702-6951)
- Kate Henaghan‐Sykes (ORCID: https://orcid.org/0009-0002-7466-2624)
- Irene Soulsby (ORCID: https://orcid.org/0000-0002-2291-831X)
- Taeko Becque (ORCID: https://orcid.org/0000-0002-0362-3794)
- B. Stuart
- Julie Hooper (ORCID: https://orcid.org/0000-0001-6580-6150)
- Joanna Slodkowska‐Barabasz (ORCID: https://orcid.org/0000-0003-0878-9504)
- Rebekah Le Feuvre
- Jacqui Nuttall
- Alison Layton
- Sinead M Langan
- Andrew R Thompson
- Zina Eminton
- Nick Francis
- Gareth Griffiths
- Mahendra Patel
- Paul Little
Institutions
- University of London (GB)
- University of Nottingham (GB)
- Queen Mary University of London (GB)
- Harrogate and District NHS Foundation Trust (GB)
- University of Bristol (GB)
- University of Oxford (GB)
- London School of Hygiene & Tropical Medicine (GB)
- NIHR Evaluation Trials and Studies Coordinating Centre (GB)
- Oxford BioMedica (United Kingdom) (GB)
- Southampton City Council (GB)
- University of Southampton (GB)
- Hull York Medical School (GB)
- Cardiff University (GB)
- University of Wales (GB)
Publication Details
- Journal
- NIHR Open Research
- Published
- 2026-07-16
- DOI
- https://doi.org/10.3310/nihropenres.14302.1
- Primary Topic
- Acne and Rosacea Treatments and Effects
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- National Institute for Health and Care Research
- Department of Health and Social Care
- Programme Grants for Applied Research