Adherence to Activity Limitations in Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes, Foot Ulcer

Intervention / Treatment
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* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients in the control group will receive treatment as usual. | |
| Experimental: Experimental<br>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<br>* Theory-based communication training programme delivered to healthcare professionals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patients' adherence to activity reduction recommendations | Measured using an accelerometer. Patients will be asked to wear the accelerometer daily for 1 month. | 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. | Baseline | 
| Acceptability of the intervention | Assessed via interviews with healthcare professionals who have taken part in the training programme and patients. | 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. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motivation, Communication, Healthcare Professional, Training, Adherence, Diabetes, Foot Ulcer