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

NCT04278742 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2020-03-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Marabelle Heng · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2020-03-31
Completion
2020-12-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04278742 on ClinicalTrials.gov