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

Not Applicable

• Conditions: Neuropathy;Peripheral; Diabetes Mellitus, Type 2
• Interventions: Other: Patient education

• Registration Number: NCT04278742
• Lead Sponsor: Singapore General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-03
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Status Verified: 2020-03
• Primary Completion: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional - collaborative education	Patient education	Collaborative style of communication whereby the clinician and patient co-creates the treatment plan

Primary Outcome Measures

Name	Time	Method
Wound healing	12 weeks	Percentage patients with healed wound (wound size = 0cm)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore