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Adherence to Activity Limitations in Diabetes

Adherence to Activity Limitation Recommendations in Patients With Diabetic Foot Ulcers: a 'Proof of Concept' Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03853941
Enrollment
49
Registered
2019-02-26
Start date
2019-03-21
Completion date
2020-09-10
Last updated
2022-05-23

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

Conditions

Diabetes, Foot Ulcer

Keywords

Motivation, Communication, Healthcare Professional, Training, Adherence, Diabetes, Foot Ulcer

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALIntervention

Theory-based communication training programme delivered to healthcare professionals

Sponsors

University of Nottingham
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Be aged 18 years and over * Have diabetes according to WHO criteria * Have a diabetic foot ulcer being treated at the foot clinic at Royal Derby Hospital * Be able to communicate and complete questionnaire measures in English * Have capacity to consent and agree to participate.

Exclusion criteria

\- Patients who are not currently engaging in walking behaviour (e.g., wheelchair-bound patients) or have other physical limitations that restrict ability to use an accelerometer will be excluded.

Design outcomes

Primary

MeasureTime frameDescription
Change in healthcare professionals' communication styleBaselineMeasured 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.

Secondary

MeasureTime frameDescription
Change in patients' adherence to activity reduction recommendations1 monthMeasured using an accelerometer. Patients will be asked to wear the accelerometer daily for 1 month.
Change in patient treatment self-regulationBaselineTreatment 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.
Acceptability of the interventionHealthcare professional interviews 4-6 weeks following training; Patient interviews 4-6 weeks following baselineAssessed via interviews with healthcare professionals who have taken part in the training programme and patients.
Fidelity of deliveryBaselineA 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026