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

NCT04278742 | Unknown

• 1 other identifier: SGH_collab_edu
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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. 1.invite patient to share their thoughts or concerns then
2. 2.clarify patient's understanding

Conditions

Diabetes Mellitus, Type 2; Neuropathy;Peripheral

Keywords

patient education

Outcome Measures

Primary Outcomes (1)

• Wound healing

  Percentage patients with healed wound (wound size = 0cm)

  12 weeks

Secondary Outcomes (2)

• Knowledge score assessed by questionnaire

  Week 1 and week 12

• Behaviour score assessed by questionnaire

  Week 1 and week 12

Study Arms (2)

Interventional - collaborative education

EXPERIMENTAL

Collaborative style of communication whereby the clinician and patient co-creates the treatment plan

Other: Patient education

Control group

NO INTERVENTION

Traditional directive and didactic style of patient information will be provided

Interventions

Patient education OTHER

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.

Also known as: Collaborative counselling

Interventional - collaborative education

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Diagnosed mental health conditions
• Diagnosed cognitive impairment
• Diagnosed visual impairment
• Diagnosed hearing and speech disabilities

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

Related Publications (2)

• 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.

  PMID: 21242475 BACKGROUND

• 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.

  PMID: 18178699 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Neuritis

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Marabelle Heng

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Suitable participants recruited and randomised into Study Intervention Group or Control Group.

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: February 20, 2020
• Study Start: December 3, 2018
• Primary Completion: March 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)