Sub-studies
We designed and conducted several sub-studies to complement and strengthen the main REDUCE trial.
These studies investigate underlying mechanisms, methodological approaches, and aspects of trial delivery, contributing to a more comprehensive understanding of the REDUCE intervention and its impact.
Study 1: Exploring biological mechanisms of action
Within REDUCE, we have an embedded NIHR Efficacy and Mechanism Evaluation (EME) Grant exploring the biological mechanisms of action of the REDUCE intervention.
Psychological and behavioural factors have long been associated with ulcer healing and recurrence, but there remain questions about the pathways by which these things are linked.
REDUCE offers a unique opportunity as we are already collecting so much psychological, behavioural, and clinical data to explore relationships between these factors and biological markers associated with ulcer healing and recurrence.
Method
Samples will be analysed for a range of immune and gene expression markers that are linked to biological processes involved in re-ulceration, skin repair and/or wound healing.
To explore this, we recruited a sub-sample of 110 REDUCE participants to the sub-study and asked them to provide blood samples at baseline and 12 weeks to assess the biological markers.
Study 2: Does sending a birthday card improve retention?
The REDUCE trial includes a study within a trial (SWAT) to evaluate whether sending a birthday card improves the retention of participants in trials involving an adult population.
Method
Participants are randomly selected to receive a birthday card for the whole of the trial duration OR no birthday card.
The primary outcome of this SWAT is whether the questionnaire was returned at the first-time point following receipt of the first birthday card.
Secondary outcomes include:
- Whether the questionnaire was returned at the first-time point following receipt of the second birthday card.
- Response rate at each time point (6-weeks, 3 months, 6 months and 18 months).
- Time to response (number of days from date due to date returned) at the first-time point following receipt of the first birthday card.
- Time to response (number of days from date due to date returned) at the first-time point following receipt of the second birthday card (where applicable).
- Needed an initial reminder at the first-time point following receipt of the first birthday card.
- Needed an initial reminder at the first-time point following receipt of the second birthday card (where applicable).
- Needed a telephone reminder at the first-time point following receipt of the first birthday card.
- Needed a telephone reminder at the first-time point following receipt of the second birthday card (where applicable).
- Cost per participant retained at the first-time point following receipt of the first birthday card.
- Cost per participant retained at the first-time point following receipt of the second birthday card (where applicable).
From researchers and clinicians to trial coordinators and collaborators, the programme is supported by a diverse team working together across the UK to ensure the successful delivery of the research.
