Clinical trial NCT04278742: A Collaborative Approach in Diabetes Foot Education - A Pragmatic Randomised Control Trial
Official title: A Collaborative Approach in Diabetes Foot Education - A Pragmatic Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Neuropathy;Peripheral
Keywords: patient education
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Suitable participants recruited and randomised into Study Intervention Group or Control Group.
Primary purpose: TREATMENT

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

1. invite patient to share their thoughts or concerns then
2. 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.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed type II diabetes
2. Above age 21
3. Plantar foot ulcer - high risk with active full-thickness ulcer
4. Pedal pulses palpable or min toe pressure of 30mmHg
5. Medium of language: English
6. Activities of daily living (ADL) independent (without carer)

Exclusion Criteria:

1. Diagnosed mental health conditions
2. Diagnosed cognitive impairment
3. Diagnosed visual impairment
4. Diagnosed hearing and speech disabilities

Primary outcomes:
measure: Wound healing
timeFrame: 12 weeks
Secondary outcomes:
measure: Knowledge score assessed by questionnaire
timeFrame: Week 1 and week 12
measure: Behaviour score assessed by questionnaire
timeFrame: Week 1 and week 12
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Marabelle Heng
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.7547/1010078.
citation: 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.