A Collaborative Approach in Diabetes Foot Education - A Pragmatic Randomised Control Trial
Study Details
Study Description
Brief Summary
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
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invite patient to share their thoughts or concerns then
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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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Interventional - collaborative education Collaborative style of communication whereby the clinician and patient co-creates the treatment plan |
Other: Patient education
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.
Other Names:
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No Intervention: Control group Traditional directive and didactic style of patient information will be provided |
Outcome Measures
Primary Outcome Measures
- Wound healing [12 weeks]
Percentage patients with healed wound (wound size = 0cm)
Secondary Outcome Measures
- Knowledge score assessed by questionnaire [Week 1 and week 12]
Knowledge score in Knowledge & Behaviour questionnaire (Maximum score 16)
- Behaviour score assessed by questionnaire [Week 1 and week 12]
Behaviour score in Knowledge & Behaviour questionnaire (Maximum score 59)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed type II diabetes
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Above age 21
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Plantar foot ulcer - high risk with active full-thickness ulcer
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Pedal pulses palpable or min toe pressure of 30mmHg
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Medium of language: English
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Activities of daily living (ADL) independent (without carer)
Exclusion Criteria:
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Diagnosed mental health conditions
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Diagnosed cognitive impairment
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Diagnosed visual impairment
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Diagnosed hearing and speech disabilities
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Singapore General Hospital | Singapore | Singapore |
Sponsors and Collaborators
- Singapore General Hospital
Investigators
- Principal Investigator: Marabelle Heng, Singapore General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Gabbay RA, Kaul S, Ulbrecht J, Scheffler NM, Armstrong DG. Motivational interviewing by podiatric physicians: a method for improving patient self-care of the diabetic foot. J Am Podiatr Med Assoc. 2011 Jan-Feb;101(1):78-84.
- Kemp EC, Floyd MR, McCord-Duncan E, Lang F. Patients prefer the method of "tell back-collaborative inquiry" to assess understanding of medical information. J Am Board Fam Med. 2008 Jan-Feb;21(1):24-30. doi: 10.3122/jabfm.2008.01.070093.
- SGH_collab_edu