An interventional study of Intervention in Diabetes and Foot Ulcer, sponsored by University of Nottingham. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-23.
Sponsored by University of Nottingham · Not applicable, Interventional, and Other
This study aims to develop and test a theory-based motivation communication training programme for healthcare professionals working with diabetic foot ulcer patients. The investigators will explore the acceptability of the training programme and examine whether the training leads to changes in healthcare professionals' communication style, and results in greater adherence to treatment recommendations (i.e., reduced weight-bearing) in patients.
This is a proof of concept, two-arm non-randomised, controlled before-and-after study. Patient outcomes (perceptions of healthcare professional communication style, treatment self-regulation and adherence to activity reduction) will be collected first during a control/usual care period. Healthcare professionals will then receive the theory-based motivation communication training programme. Subsequently a new group of patients will be recruited as the intervention group and the same outcome measures collected. Control group outcomes will be compared to intervention group outcomes. Interviews will be conducted with healthcare professionals and patients to assess acceptability of the intervention.
691 studies on the registry are indexed under Foot Ulcer; 96 are open to participants now.
This study's enrollment of 49 is below the median of 60 across 562 interventional studies indexed under Foot Ulcer.
Browse Foot Ulcer studies →University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in the control group will receive treatment as usual.
The experimental group will receive clinical treatment as usual, however, the healthcare professionals treating them will have received training on how to enhance patient adherence via the use of a motivationally supportive communication style. Thus, the style/language healthcare professionals use to convey usual treatment recommendations may differ.
Behavioral: Intervention
Theory-based communication training programme delivered to healthcare professionals
Change in healthcare professionals' communication style
Measured using the 6-item Health Care Climate Questionnaire, and indicated by patients' perceptions of healthcare professional autonomy support being higher in the intervention group compared to the control group.
Time frame: Baseline
Change in patients' adherence to activity reduction recommendations
Measured using an accelerometer. Patients will be asked to wear the accelerometer daily for 1 month.
Time frame: 1 month
Change in patient treatment self-regulation
Treatment self-regulation is the reasons why patients may adhere or not and is a potential mechanism explaining the relationship between healthcare professional autonomy support and patient adherence to treatment recommendations.
Time frame: Baseline
Acceptability of the intervention
Assessed via interviews with healthcare professionals who have taken part in the training programme and patients.
Time frame: Healthcare professional interviews 4-6 weeks following training; Patient interviews 4-6 weeks following baseline
Fidelity of delivery
A researcher will sit in on up to 20 patient/healthcare professional consultation sessions (10 prior to training and 10 post training). The researcher will record observations of the communication style used by the healthcare professionals within the sessions. Observations will be assessed for fidelity of delivery using a checklist developed specifically for this study. Data from pre and post-training observations will be compared for differences in communication style.
Time frame: Baseline
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Nottingham