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

NCT ID: NCT04278742

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-03
• Study Completion Date: 2020-12-31

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.

Conditions

Diabetes Mellitus, Type 2; Neuropathy;Peripheral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interventional - collaborative education

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

Group Type: EXPERIMENTAL

Patient education

Intervention Type: 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.

Control group

Traditional directive and didactic style of patient information will be provided

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Collaborative counselling

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marabelle Heng

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

Singapore General Hospital

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: BACKGROUND

PMID: 21242475 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18178699 (View on PubMed)

Other Identifiers

SGH_collab_edu

Identifier Type: -

Identifier Source: org_study_id