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
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring patient education
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
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
NCT ID
NCT04278742
First Posted
December 17, 2018
Last Updated
March 17, 2020
Sponsor
Singapore General Hospital
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
background
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
background
Learn more about this trial
A Collaborative Approach in Diabetes Foot Education - A Pragmatic Randomised Control Trial
We'll reach out to this number within 24 hrs