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The Help for Hay Fever Study

Can a goal-focussed intervention delivered in Scottish community pharmacies improve outcomes for people with intermittent allergic rhinitis? A pilot randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN43606442
Enrollment
144
Registered
2012-06-18
Start date
2012-05-31
Completion date
Unknown
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Allergic Rhinitis (Hay Fever) Respiratory Allergic rhinitis, unspecified

Interventions

A random sample of twelve community pharmacies will be selected from those responding positively to an invitation to participate. Selected pharmacies will be randomly allocated to intervention or cont
advice from pharmacy staff about treatment and management of AR
a goal card with two pre-determined goals (Eliminate/minimise hay fever symptoms and avoid/minimise hay fever triggers)
and a card to record their personal symptoms and triggers. Pharmacy staff will support participants in formulating action plans for achieving the two goals.

Sponsors

University of Aberdeen (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Community pharmacies, from the two nominated study areas in Scotland, with staff available to attend training if randomised to the intervention group. Community pharmacy customers who: 1. Present opportunistically in participating community pharmacies 2. Have a history of intermittent allergic rhinitis i.e. experience symptoms on =4 days per week OR <4 weeks 3. Are currently experiencing symptoms of allergic rhinitis, defined as 2 or more of the following symptoms for =1 hour on most days: runny nose with both sides affected, blocked nose on both sides, itchy nose, sudden bouts of sneezing,sore, red, itchy eyes, itchy throat. 4. Are 18 years of age or over 5. Are able to speak, write and understand English

Exclusion criteria

Exclusion criteria: Community pharmacies, from the two nominated study areas in Scotland, whose staff are not available to attend training if randomised to the intervention group. Community pharmacy customers who: 1. Present with any of the following symptoms: blocked nose with no other symptoms suggestive of hay fever, thick yellow or green nose discharge, thick mucus at the back of the throat, sinus pain, recurrent nose bleeds, loss of smell. 2. Are under 18 years of age 3. Are unable to speak, write or understand English 4. Are pregnant 5. Are terminally ill 6. Have participated in another hay fever study within the last two years

Design outcomes

Primary

MeasureTime frame
Outcome measures have been selected to represent a range of clinical indicators and social functioning that are relevant to allergic rhinitis. Quality of Life (QOL), measured using a validated and widely used disease specific health status instrument (mini Rhinoconjunctivitis Quality of Life Questionnaire- miniRQLQ, (Juniper, 2000)), whose ?psychometric properties and minimally clinically important difference? are well described. QOL will be measured by questionnaire on the day of recruitment, and one week and six weeks after recruitment.

Secondary

MeasureTime frame
Pharmacy staff: 1. A multiple choice questionnaire will measure knowledge of Allergic Rhinitis management and treatment before and after the intervention. For the intervention group, training will be evaluated using a questionnaire based on the one used previously in Australia. 2. Semi-structured telephone interviews with a sub-sample of pharmacy staff (one from each intervention pharmacy) will collect qualitative data about their experiences of implementing the intervention, perceived benefits of and barriers to introducing it into usual practice, and general issues around acceptability of and satisfaction with the intervention 3. The interview schedule will be informed by the findings of the Australian study. Questions assessing the estimated time input of pharmacists per client will also be included to inform the economic analysis. Pharmacy customers: We will measure the following patient-reported outcomes: 1. Quality Of Life using the miniRQLQ 2. Generic health status using the EQ-5D 3. Symptom severity using the adapted 12-item Spector scale used in the Australian studies 4. Productivity using the 6-item Work Productivity and Activity Impairment Questionnaire: Allergy Specific 5. Medication adherence using the 5-item Medication Adherence Reporting Scale 6. Self-efficacy using a 6-item generic instrument adapted for Allergic Rhinitis by the Australian team 7. Allergic Rhinitis related contacts with health services since recruitment, measured by patient self-report 8. Medication use during the 6-week follow-up period by patient self-report

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026