Community pharmacists optimising treatment for patients with psoriasis
| ISRCTN | ISRCTN67700775 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67700775 |
| Protocol serial number | 16412 |
| Sponsor | Robert Gordon University (UK) |
| Funder | The Psoriasis and Psoriatic Arthritis Alliance (PAPAA) (UK) |
- Submission date
- 22/05/2014
- Registration date
- 22/05/2014
- Last edited
- 16/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Psoriasis is a long-term inflammatory skin condition that affects up to 2% of the people in the UK. There is no cure for psoriasis and the condition tends to come and go but once it has developed it is normally life-long. The majority of people with psoriasis need to use creams or ointments on a daily basis. This requires a high level of commitment yet research shows that many people dont get enough advice from anyone on how to use them. As a result, psoriasis is often poorly managed by patients. In this study we want to see if advice given by community pharmacists can lead to better management of psoriasis and ultimately improvements in the severity of the condition.
Who can participate?
The study is open to anyone over the age of 18 who is prescribed creams or ointments to manage their psoriasis.
What does the study involve?
Patients who visit participating community pharmacies to collect their prescriptions for topical psoriasis treatments will be invited by the pharmacist or a member of staff to join the study. The study involves two consultations with the pharmacist. At the first appointment the pharmacist will use a specially designed guide to ask the person several questions to assess their understanding of psoriasis and if they know how to use their treatments. The pharmacist will also ask the person to complete two further questionnaires; one of these looks at the impact of psoriasis on their quality of life and the second asks them to rate the severity of their psoriasis. Both of these questionnaires have been used previously in research studies and are very quick and easy to complete. During the initial appointment the pharmacist will provide advice to help the person use their treatments properly. A second appointment will then be arranged for about 4 weeks later to go through the same initial questions to see if the person now has a better understanding of what to do with their treatments. The two questionnaires will also be repeated to see if the persons quality of life is improved and if they think their psoriasis is less severe.
What are the possible benefits and risks to participants?
The benefits for the patients are that they should have a better understanding of their condition and how to manage it. It is also likely that improvements in both quality of life and disease severity will occur once the person knows more about how to use treatments properly. There are unlikely to be any risks associated with the study.
Where is the study run from?
The study will be run from participating pharmacies and is being co-ordinated by Robert Gordon University, Aberdeen.
When is the study starting and how long it is expected to run for?
We hope to start the study in September 2014 and it will continue until we have recruited and completed two interviews with 30 patients.
Who is funding the study?
The Psoriasis and Psoriatic Arthritis Alliance (UK).
Who is the main contact?
Dr Rod Tucker
rodtucker@rodtucker.karoo.co.uk
Contact information
Scientific
LLoyds Pharmacy, 4 Market Place
Hornsea
HU181AW
United Kingdom
| rodtucker@rodtucker.karoo.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised Interventional Design type: Process of Care |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Is it feasible for community pharmacists to deliver an educational programme designed to help people with psoriasis self-manage as effectively as possible? |
| Study objectives | This study attempts to explore whether advice provided by community pharmacists to patients with mild to moderate psoriasis can lead to an improvement in their ability to self-manage their psoriasis. |
| Ethics approval(s) | Office for Research and Ethics Committees Northern Ireland, 16/12/2013, ref. 13/NI/0207 |
| Health condition(s) or problem(s) studied | Topic: Primary Care; Subtopic: Not Assigned; Disease: All Diseases |
| Intervention | The pharmacists will opportunistically approach patients who present with prescriptions for themselves for psoriasis. Eligible patients who agree to participate will be asked to complete the SAPASI and DLQI forms and will have a private consultation with the pharmacist to discuss the PEDESI tool. The tool will identify and gaps in patients knowledge and understanding of their condition and its management. A follow-up appointment will be made approximately 4 weeks later to reassess the outcome measures and revisit the PEDESI tool to determine whether patients now feel more confident at self-managing their psoriasis. |
| Intervention type | Other |
| Primary outcome measure(s) |
Pedesi; Timepoint(s): at follow-up after 6 weeks |
| Key secondary outcome measure(s) |
Dermatology quality of life index (DLQI); Timepoint(s): 6 weeks, at the follow-up appointment; sapasi; Timepoint(s): 6 weeks, at follow-up appointment |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Patients aged over 18 with a diagnosis of chronic plaque psoriasis currently prescribed topical treatment 2. Male & Female 3. Lower Age Limit: 18 no age limit or unit specified |
| Key exclusion criteria | Patients under 18 years, prescribed oral therapy or receiving phototherapy |
| Date of first enrolment | 30/07/2014 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hornsea
HU181AW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/03/2017: Publication reference added.
