Reducing the impact of DFUs (REDUCE): Pilot trial
Research type
Research Study
Full title
Reducing the impact of diabetic foot ulcers: Pilot trial
IRAS ID
274356
Contact name
Frances Game
Contact email
Sponsor organisation
University Hospitals of Derby and Burton NHS Foundation Trust
ISRCTN Number
ISRCTN15460422
Duration of Study in the UK
0 years, 11 months, 13 days
Research summary
Research Summary
Background: Diabetic foot ulcers (DFUs) are poorly healing wounds below the ankle affecting 25% of people with diabetes. Less than half of people will be ulcer-free after 6 months of treatment, and the same number will experience another ulcer within a year.
Current treatments to prevent and heal ulcers do not work well. People’s thoughts, feelings and behaviours can affect the risk of getting DFUs and how they heal. We have developed a new way of helping people with diabetes who have had a foot ulcer previously, called ‘REDUCE’. The package includes 8 one hour sessions with a healthcare professional (HCP), such as a diabetes nurse, and support through a new website.
Aims: To explore if the REDUCE training programme or trial procedures need amending before conducting main trial.
Method: 20 patients will be recruited to take part in this study. Fourteen patients will be randomly allocated to receive the REDUCE package and six patients to receive their usual care. Patients will be identified by their clinical care team or screening of clinic lists.Outcomes: All participants will complete a questionnaire at the start of the study and at 6 and 12 weeks. REDUCE package participants will be interviewed at the start and 4 months later. HCPs will be interviewed after they have delivered all their REDUCE sessions; a sample of sessions will be recorded to check how closely they are following the delivery of the REDUCE programme. A participant’s use of NHS resources during their time in the study (e.g. new admissions to hospital, new foot ulcers) will be collected.
Public Involvement: The public involvement panel have been involved in the design and development of the study and the intervention. They continue to contribute to the study as we progress.
Summary of Results
The REDUCE Pilot trial was a ‘small-scale’ study designed to gather data to support the development and planning of a large effectiveness and cost-effectiveness trial (the main REDUCE Trial). The planned main trial is designed to examine whether a psychological and behavioural intervention (REDUCE) plus usual care can increase the number of ulcer free days in patients at high risk of diabetic foot ulcers compared to usual care alone.
The REDUCE Pilot trial gathered information regarding a number of key features of the planned main REDUCE trial including: how many patients would be eligible for trial recruitment; how many eligible patients would agree to participate; intervention engagement; whether primary and secondary outcome data could be collected reliably; and the acceptability of the intervention & trial procedures. Key findings are summarised below:Recruitment:
The study planned to recruit 16-20 patients, and this was achieved in line with planned timelines. Over 3 months of recruitment, 103 patients were screened to assess for their eligibility to be approached about the trial. Of these 29 did not meet the inclusion criteria. Of the 74 eligible participants, 54 did not consent to take part in the study. The main reasons given included they felt it was “too much for them” and they did not want to take part in research. A total of 20 patients were recruited (meeting the upper limit of our planned target), who were randomly allocated to receive either the REDUCE intervention (n=13) plus their usual care or just their usual care alone (n=7). Patients were randomised 2:1 in favour of the intervention to allow capacity to explore if the REDUCE intervention needed any modifications or adaptations for either the participants or the Health Care Professionals (HCPs) delivering the intervention before being used in the full trial. Analysis of baseline demographic and clinical data showed the two groups were similar.Intervention Engagement:
The ‘initiation’ phase of the REDUCE intervention is made up of 8 sessions with a health care professional. For the 13 participants randomised into the intervention group, 8 (61.5%) participants completed all sessions, 2 (15.4%) completed 7 sessions, 1 (7.7%) completed 5 sessions, 1 (7.7%) completed 1 session and 1 participant did not complete any sessions. Participants were given the option of completing their sessions either on the phone or via an online platform (Zoom or Teams); we found the method of delivery evenly split between the two options, participants who opted for an online platform were more likely to choose to use Zoom (n=6) than Teams (n=1).
The ‘maintenance’ phase of the REDUCE intervention includes access to a digital maintenance programme and a package of offline resources developed to maintain positive behavioural and psychological changes. Of the 13 intervention participants, 3 (23.1%) logged into the digital maintenance intervention. Two participants only logged in once (for 10 minutes 52 seconds and 3 minutes each), while one participant logged in a total of 9 times, for a total duration of 47 minutes and 12 seconds.Outcome Data Collection:
We were able to successfully collect primary outcome data (number of ulcer-free days) for all participants in the trial. For participant reported follow-ups we were able to successfully collect data from 16 (80%) participants at 6 weeks follow-up and 15 (75%) participants at 3 months follow-up.
Intervention & Trial Procedures Acceptability:
All participants randomised to the intervention group were invited to take part in post-trial interviews. HCPs delivering REDUCE sessions were also invited to take part in an interview after they had completed the delivery of all their allocated one-to-one sessions with participants. Interviews were audio recorded and transcribed verbatim. A total of 12 (of possible 13) participants and all three HCPs were interviewed. Overall, feedback on the one-to-one sessions was extremely positive. These interactions were described as welcome and/or enjoyable by the vast majority of participants. Participants were all provided with a hard copy handbook which would be used in the one-to-one sessions, HCP’s described using the handbook within sessions to anchor their conversations with participants. Their sense was that participants varied in the use they made of these materials outside of the sessions. Interviews with participants suggest that this perception was correct: some described making very limited use of the manual (giving it an initial ‘thumb through’ only); others said they had used it to prepare themselves for sessions and/or to ‘revise’ what they had discussed previously. Additionally, the interviews highlighted that there was variation between HCPs, and participants, with regard to whether and how the maintenance intervention had been introduced. Levels of independent engagement with the digital version were low, with participants (who used the internet) saying they had: not got round to it; had forgotten about the website; had lost the link/log-in information; and/or accessed it but judged it as offering them ‘nothing new’ (i.e., not warranting extended attention or further visits).Conclusions/Lessons Learned:
We have been able to consider a number of modifications to the questionnaires, procedures and the REDUCE intervention before moving forward with the full randomised controlled trial following the completion of the REDUCE Pilot. Some of these changes included:
• Reviewing and amending the participant questionnaires including the removal of some measures (Generalised Anxiety Disorder Assessment; Mental Health Continuum Short Form), reduction of other measures (Social Provision Scale (24 item) changed for 5 item version) and organising the health economic questions so they are easier to complete for participants;
• Developing a patient infographic to assist with patient recruitment to the trial;
• Implementing an SMS or phone call reminder before the consent visit by patients as we found at the beginning of recruitment some patients did not attend because they thought the appointment had been cancelled as they routinely receive appointment reminders usually for NHS appointments;
• Developing a letter to inform non-NHS clinicians (e.g. private podiatrists) their patient is taking part in the trial;
• Personalisation and tailoring of intervention sessions to each participant, for example adjusting activity goals in line with individual characteristics (e.g., age, baseline activity). The HCP training and training manual are being updated to reflect this and training will empower HCPs to align sessions according to participant characteristics.
• Combining all participant offline maintenance REDUCE materials in one handbook, formatting of participant diaries, addition of session synopses, introduction of Maintenance Intervention earlier in the session schedule.The REDUCE Pilot has now moved onto the full trial. We are now in the process of setting up sites and recruiting patients into the trial.
REC name
Wales REC 3
REC reference
21/WA/0110
Date of REC Opinion
29 Apr 2021
REC opinion
Further Information Favourable Opinion