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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04278742
• Other study ID #: SGH_collab_edu
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: December 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Neuropathy;Peripheral
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing	Percentage patients with healed wound (wound size = 0cm)	12 weeks
Secondary	Knowledge score assessed by questionnaire	Knowledge score in Knowledge & Behaviour questionnaire (Maximum score 16)	Week 1 and week 12
Secondary	Behaviour score assessed by questionnaire	Behaviour score in Knowledge & Behaviour questionnaire (Maximum score 59)	Week 1 and week 12