BACKGROUND: Large numbers of people are expected to self-manage their skin condition, but limited attention has been given to studies of self-management in psoriasis, neither clearly highlighting the challenge nor seeking to develop interventions to support its effectiveness. OBJECTIVES: 1. To test the feasibility of a new educational intervention to enable people with psoriasis to self-manage more effectively an adequately powered multi-centred trial design through piloting. METHOD: Pilot randomized controlled trial with adults (n = 64) with mild-moderate psoriasis in Primary Care in the United Kingdom. Both groups continued with usual treatment. A theory-based educational intervention was designed. The primary outcome measure was the Dermatology Life Quality Index (DLQI). Secondary measures included the Psoriasis Area and Severity Index (PASI) and qualitative feedback from participants. Assessment of the feasibility of the intervention included recruitment and acceptability to participants. RESULTS: Delivery of the intervention was feasible and positively evaluated. Recruitment strategies and the intervention need minor modification. As a pilot study there was insufficient power to detect significant score changes. Sub group analysis of participants with a PASI or DLQI of >6 indicated a modest reduction in PASI in the intervention group which demonstrates a trend that may indicate that this intervention has potential value for people with moderate psoriasis when combined with qualitative data. CONCLUSION: This study highlights the feasibility of delivering a self-efficacy based educational intervention for people with mild-moderate psoriasis in primary care establishing the numbers and design required for an adequately powered multi-centred trial.
RCT Entities:
BACKGROUND: Large numbers of people are expected to self-manage their skin condition, but limited attention has been given to studies of self-management in psoriasis, neither clearly highlighting the challenge nor seeking to develop interventions to support its effectiveness. OBJECTIVES: 1. To test the feasibility of a new educational intervention to enable people with psoriasis to self-manage more effectively an adequately powered multi-centred trial design through piloting. METHOD: Pilot randomized controlled trial with adults (n = 64) with mild-moderate psoriasis in Primary Care in the United Kingdom. Both groups continued with usual treatment. A theory-based educational intervention was designed. The primary outcome measure was the Dermatology Life Quality Index (DLQI). Secondary measures included the Psoriasis Area and Severity Index (PASI) and qualitative feedback from participants. Assessment of the feasibility of the intervention included recruitment and acceptability to participants. RESULTS: Delivery of the intervention was feasible and positively evaluated. Recruitment strategies and the intervention need minor modification. As a pilot study there was insufficient power to detect significant score changes. Sub group analysis of participants with a PASI or DLQI of >6 indicated a modest reduction in PASI in the intervention group which demonstrates a trend that may indicate that this intervention has potential value for people with moderate psoriasis when combined with qualitative data. CONCLUSION: This study highlights the feasibility of delivering a self-efficacy based educational intervention for people with mild-moderate psoriasis in primary care establishing the numbers and design required for an adequately powered multi-centred trial.
Authors: Steven J Ersser; Fiona Cowdell; Sue Latter; Eric Gardiner; Carsten Flohr; Andrew Robert Thompson; Karina Jackson; Helen Farasat; Fiona Ware; Alison Drury Journal: Cochrane Database Syst Rev Date: 2014-01-07