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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2; Neuropathy;Peripheral
• Intervention / Treatment: Other: Patient education

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Collaborative counselling
No Intervention: Control group; Traditional directive and didactic style of patient information will be provided

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Investigators: Principal Investigator: Marabelle Heng, Singapore General Hospital

Publications and helpful links

General 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. doi: 10.7547/1010078.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: patient education
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Endocrine System Diseases; Neuromuscular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Peripheral Nervous System Diseases
• Other Study ID Numbers: SGH_collab_edu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will only be available to the PI. The study team will be analysing de-identified data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No