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

Sponsor
Singapore General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04278742
Collaborator
(none)
240
1
2
24
10

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Patient education
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Suitable participants recruited and randomised into Study Intervention Group or Control Group.Suitable participants recruited and randomised into Study Intervention Group or Control Group.
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Collaborative Approach in Diabetes Foot Education - A Pragmatic Randomised Control Trial
Actual Study Start Date :
Dec 3, 2018
Anticipated Primary Completion Date :
Mar 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Wound healing [12 weeks]

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

    Secondary Outcome Measures

    1. Knowledge score assessed by questionnaire [Week 1 and week 12]

      Knowledge score in Knowledge & Behaviour questionnaire (Maximum score 16)

    2. Behaviour score assessed by questionnaire [Week 1 and week 12]

      Behaviour score in Knowledge & Behaviour questionnaire (Maximum score 59)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Singapore General Hospital Singapore Singapore

    Sponsors and Collaborators

    • Singapore General Hospital

    Investigators

    • Principal Investigator: Marabelle Heng, Singapore General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Singapore General Hospital
    ClinicalTrials.gov Identifier:
    NCT04278742
    Other Study ID Numbers:
    • SGH_collab_edu
    First Posted:
    Feb 20, 2020
    Last Update Posted:
    Mar 19, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Singapore General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 19, 2020