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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04278742
Enrollment
240
Registered
2020-02-20
Start date
2018-12-03
Completion date
2020-12-31
Last updated
2020-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Neuropathy;Peripheral

Keywords

patient education

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.

Interventions

OTHERPatient 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

Singapore General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Suitable participants recruited and randomised into Study Intervention Group or Control Group.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Wound healing12 weeksPercentage patients with healed wound (wound size = 0cm)

Secondary

MeasureTime frameDescription
Knowledge score assessed by questionnaireWeek 1 and week 12Knowledge score in Knowledge & Behaviour questionnaire (Maximum score 16)
Behaviour score assessed by questionnaireWeek 1 and week 12Behaviour score in Knowledge & Behaviour questionnaire (Maximum score 59)

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026