A Collaborative Approach in Diabetes Foot Education - A Pragmatic Randomised Control Trial

Study Overview
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Brief Summary
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Traditional directive style of requesting or demanding compliance to set behavior is found to have little effect on patient's self-care behavior. It is reported that patients prefer to restate or rephrase their understanding in a care setting, instead of a directive/didactic approach where the clinician provides 'one-way' information. In fact, directive persuasion is thought to lead to resistance to change and is counter-effective. New approaches such as open ended communication, interview style and collaborative approach is found to engage patients better in their own care and elicit patient's own intrinsic motivations for making changes. One way to do this is to invite patient to share their thoughts or concerns then clarify patient's understanding From their responses: (3a) affirm patient's correct understanding or (3b) address misconceptions with permission. In this study, the investigators will randomize 240 subjects into two groups: Group A will undergo the above describe collaborative approach to patient education and counselling; Group B will undergo current (traditional, didactic approach) patient education. It is hypothesized that the collaborative approach group (Group A) should experience better understand of their health condition and foot ulcer, be better able to adhere to treatment plan through collaborative participation and overall be more satisfied with the treatment. Outcomes will be tracked at (i) post intervention and (ii) 4 months post intervention.

Official Title
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A Collaborative Approach in Diabetes Foot Education - A Pragmatic Randomised Control Trial

Conditions
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Diabetes Mellitus, Type 2, Neuropathy;Peripheral

Intervention / Treatment
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* Other: Patient education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed type II diabetes Above age 21 Plantar foot ulcer - high risk with active full-thickness ulcer Pedal pulses palpable or min toe pressure of 30mmHg Medium of language: English Activities of daily living (ADL) independent (without carer) Exclusion Criteria: Diagnosed mental health conditions Diagnosed cognitive impairment Diagnosed visual impairment Diagnosed hearing and speech disabilities

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Suitable participants recruited and randomised into Study Intervention Group or Control Group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional - collaborative education<br>Collaborative style of communication whereby the clinician and patient co-creates the treatment plan | Other: Patient education<br>* Using a collaborative approach to engage patients in their own care, allowing patients to continue to have full control of their treatment. The clinician and patient co-creates the treatment plan.<br>* Other names: Collaborative counselling;|
| No Intervention: Control group<br>Traditional directive and didactic style of patient information will be provided | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Percentage patients with healed wound (wound size = 0cm) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge score assessed by questionnaire | Knowledge score in Knowledge & Behaviour questionnaire (Maximum score 16) | Week 1 and week 12 | 
| Behaviour score assessed by questionnaire | Behaviour score in Knowledge & Behaviour questionnaire (Maximum score 59) | Week 1 and week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient education