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

Primary Purpose

Diabetes Mellitus, Type 2, Neuropathy;Peripheral

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Patient education
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring patient education

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Singapore General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional - collaborative education

Control group

Arm Description

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

Traditional directive and didactic style of patient information will be provided

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Knowledge score assessed by questionnaire
Knowledge score in Knowledge & Behaviour questionnaire (Maximum score 16)
Behaviour score assessed by questionnaire
Behaviour score in Knowledge & Behaviour questionnaire (Maximum score 59)

Full Information

First Posted
December 17, 2018
Last Updated
March 17, 2020
Sponsor
Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04278742
Brief Title
A Collaborative Approach in Diabetes Foot Education - A Pragmatic Randomised Control Trial
Official Title
A Collaborative Approach in Diabetes Foot Education - A Pragmatic Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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 invite patient to share their thoughts or concerns then 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Neuropathy;Peripheral
Keywords
patient education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Suitable participants recruited and randomised into Study Intervention Group or Control Group.
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional - collaborative education
Arm Type
Experimental
Arm Description
Collaborative style of communication whereby the clinician and patient co-creates the treatment plan
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Traditional directive and didactic style of patient information will be provided
Intervention Type
Other
Intervention Name(s)
Patient education
Other Intervention Name(s)
Collaborative counselling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound healing
Description
Percentage patients with healed wound (wound size = 0cm)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Knowledge score assessed by questionnaire
Description
Knowledge score in Knowledge & Behaviour questionnaire (Maximum score 16)
Time Frame
Week 1 and week 12
Title
Behaviour score assessed by questionnaire
Description
Behaviour score in Knowledge & Behaviour questionnaire (Maximum score 59)
Time Frame
Week 1 and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Diagnosed mental health conditions Diagnosed cognitive impairment Diagnosed visual impairment Diagnosed hearing and speech disabilities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marabelle Heng
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will only be available to the PI. The study team will be analysing de-identified data
Citations:
PubMed Identifier
21242475
Citation
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.
Results Reference
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PubMed Identifier
18178699
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.
Results Reference
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A Collaborative Approach in Diabetes Foot Education - A Pragmatic Randomised Control Trial

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